HRB Open Research
HRB Open Research 2020, 3:86 Last updated: 14 MAY 2021
STUDY PROTOCOL
ReStOre@Home: Feasibility study of a virtually delivered 12week multidisciplinary rehabilitation programme for
survivors of upper gastrointestinal (UGI) cancer - study
protocol [version 1; peer review: 2 approved with
reservations]
Linda O'Neill 1,2, Emer Guinan2,3, Suzanne L. Doyle4, Louise O'Connor1,2,
Grainne Sheill 1,2, Emily Smyth1,2, Ciaran M. Fairman 5, Ricardo Segurado 6,
Deirdre Connolly 2,7, Jacintha O'Sullivan2,8, John V. Reynolds2,8, Juliette Hussey1,2
1Discipline of Physiotherapy, Trinity College Dublin, the University of Dublin, Dublin, Ireland
2Trinity St James's Cancer Institute, Dublin, Ireland
3School of Medicine, Trinity College Dublin, the University of Dublin, Dublin, Ireland
4School of Biological and Health Sciences, Technological University Dublin, Dublin, Ireland
5Department of Exercise Science, Arnold School of Public Health, University of South Carolina, Columbia, USA
6School of Public Health, Physiotherapy and Sports Sciences,, University College Dublin, Dublin, Ireland
7Discipline of Occupational Therapy, Trinity College Dublin, the University of Dublin, Dublin, Ireland
8Department of Surgery, Trinity Translational Medicine Institute, Trinity College Dublin, the University of Dublin and St James's
Hospital Dublin, Dublin, Ireland
v1
First published: 25 Nov 2020, 3:86
https://doi.org/10.12688/hrbopenres.13185.1
Open Peer Review
Latest published: 04 May 2021, 3:86
https://doi.org/10.12688/hrbopenres.13185.2
Reviewer Status
Abstract
Background: Exercise rehabilitation programmes, traditionally
involving supervised exercise sessions, have had to rapidly adapt to
virtual delivery in response to the coronavirus disease 2019 (COVID19) pandemic to minimise patient contacts. In the absence of an
effective vaccine, the pandemic is likely to persist in the medium term
and during this time it is important that the feasibility and
effectiveness of remote solutions is considered. We have previously
established the feasibility of the Rehabilitation Strategies following
Oesophago-gastric Cancer (ReStOre) intervention - a face to face
multidisciplinary rehabilitation programme for upper gastrointestinal
(UGI) cancer survivors. This study will examine the feasibility of a
virtually delivered 12-week multi-component ReStOre@Home
programme.
Methods: This single arm feasibility study will recruit 12 patients who
have completed curative treatment for oesophago-gastric cancer.
Participants will complete the 12-week ReStOre@Home programme
Invited Reviewers
1
2
version 2
(revision)
report
04 May 2021
version 1
25 Nov 2020
report
report
1. Lara Edbrooke, University of Melbourne,
Melbourne, Australia
Linda Denehy, University of Melbourne,
Melbourne, Australia
Page 1 of 21
HRB Open Research
consisting of exercise (aerobic and resistance training), 1:1 dietary
counselling and group education sessions through virtual delivery.
Underpinned by the Medical Research Council (MRC) Framework,
feasibility will be determined by recruitment rates, adherence,
retention, incidents, and acceptability. Acceptability will be assessed
qualitatively through post-intervention interview and the Telehealth
Usability Questionnaire. Secondary outcomes will be assessed pre and
post-intervention and will include measures of physical performance
(cardiopulmonary exercise test, short physical performance battery,
hand grip strength, Godin Leisure Time Questionnaire, and body
composition), health related quality of life (European Organisation for
Research and Treatment of Cancer Core Quality of Life Questionnaire
(EORTC-QLQ-C30) and oesophago-gastric cancer specific subscale
(EORTC-QLQ-OG25), fatigue (Multidimensional Fatigue Inventory (MFI20), and venous blood samples will be collected for the UGI Cancer
Survivorship Biobank.
Discussion: The ReStOre@Home feasibility study will provide
important data regarding the amenability of a multidisciplinary
programme designed for UGI cancer survivors to virtual delivery.
Trial registration: ClinicalTrials.gov NCT04603339 (26/10/2020)
HRB Open Research 2020, 3:86 Last updated: 14 MAY 2021
2. Cynthia Forbes
, University of Hull, Hull,
UK
Any reports and responses or comments on the
article can be found at the end of the article.
Keywords
Virtual delivery, multidisciplinary rehabilitation, upper gastrointestinal
cancer, exercise, diet, education
Corresponding author: Linda O'Neill (oneilll8@tcd.ie)
Author roles: O'Neill L: Conceptualization, Methodology, Project Administration, Writing – Original Draft Preparation; Guinan E:
Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing; Doyle SL: Funding Acquisition, Methodology, Writing –
Review & Editing; O'Connor L: Methodology, Project Administration, Writing – Review & Editing; Sheill G: Conceptualization,
Methodology, Project Administration, Writing – Review & Editing; Smyth E: Investigation, Project Administration, Writing – Review &
Editing; Fairman CM: Methodology, Writing – Review & Editing; Segurado R: Funding Acquisition, Methodology, Resources, Writing –
Review & Editing; Connolly D: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing; O'Sullivan J:
Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing; Reynolds JV: Conceptualization, Funding Acquisition,
Methodology, Supervision, Writing – Review & Editing; Hussey J: Conceptualization, Funding Acquisition, Methodology, Supervision,
Visualization, Writing – Review & Editing
Competing interests: No competing interests were disclosed.
Grant information: Health Research Board Ireland [DIFA-FA-2018-009]
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Copyright: © 2020 O'Neill L et al. This is an open access article distributed under the terms of the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite this article: O'Neill L, Guinan E, Doyle SL et al. ReStOre@Home: Feasibility study of a virtually delivered 12-week
multidisciplinary rehabilitation programme for survivors of upper gastrointestinal (UGI) cancer - study protocol [version 1; peer
review: 2 approved with reservations] HRB Open Research 2020, 3:86 https://doi.org/10.12688/hrbopenres.13185.1
First published: 25 Nov 2020, 3:86 https://doi.org/10.12688/hrbopenres.13185.1
Page 2 of 21
HRB Open Research 2020, 3:86 Last updated: 14 MAY 2021
Introduction
We have previously established the safety, feasibility and
initial efficacy of multidisciplinary rehabilitation in oesophagogastric cancer survivorship, an understudied cohort of cancer
survivors with significant nutritional, functional, and quality
of life needs1–3. The ReStOre (Rehabilitation Strategies following Oesophago-gastric Cancer) feasibility study4,5 and pilot randomised controlled trial (RCT)6,7 demonstrated that a 12-week
programme of supervised and homebased exercise, 1:1 dietary counselling, and health education could result in clinically
significant improvements in cardiorespiratory fitness and
physical and mental well-being without compromise to body
composition in this nutritionally vulnerable cohort. Thus the
ReStOre RCT is the first evidence-based model of rehabilitation
in UGI cancer survivorship. The ReStOre II (Rehabilitation
Strategies following Oesophagogastric and Hepatopancreaticobiliary Cancer) RCT now plans to further examine the effectiveness of the ReStOre programme by RCT in a larger cohort of
upper-gastrointestinal (UGI) cancer survivors8. However, due
to the coronavirus disease 2019 (COVID-19) pandemic plans
to commence recruitment to the ReStOre II RCT have been
delayed until public health advice facilitates implementation of
such activities.
The COVID-19 pandemic has changed all our lives and how
we go about our activities of daily living, including how we
exercise. Rehabilitation including exercise therapy is an important part of recovery from cancer9, and efforts to continue these
interventions are a priority despite COVID-1910. However, delivery of rehabilitative programmes has been greatly inhibited
due to the pandemic. Current barriers to the implementation of
cancer rehabilitation in Ireland and internationally include the
need for vulnerable cohorts to cocoon, a reluctance amongst
high risk cohorts to attend appointments in healthcare environments due to infection control fears, the need for physical
distancing, public health recommendations to minimise use of
public transport, and rolling restrictions11. As a means of overcoming these barriers, remote delivery is an attractive alternative mode of providing much needed rehabilitative services to
cancer survivors within the safety of their own homes12. In recent
years, the feasibility and efficacy of delivering rehabilitation
virtually to patients living with and beyond cancer has been
increasingly explored in exercise oncology research. Whilst initial results of trials are largely supportive of virtual delivery13,14,
little is known regarding the feasibility of delivering multidisciplinary rehabilitation virtually to survivors of UGI cancers.
Whilst video-conferencing provides an ideal vehicle for delivery
of established rehabilitation programmes at this time, successful transition to a virtual model needs to be multidimensional,
delivering all the essential components of the planned rehabilitative intervention including group exercise sessions, 1:1
dietary consultations, group education sessions and opportunity for group discussion. These contrasting modes of participant
engagement and interaction requires rigorous evaluation to establish effectiveness and comparability to face-to-face models
of care. Moreover, face to face programmes in cancer survivorship are advocated for their innate social value, whereby
participants benefit hugely from the peer support gained from
meeting and engaging with other cancer survivors, validating
their role as experts in their condition7. However, it is unknown
if such social benefits may translate to a virtually delivered
programme.
To this end, the COVID-19 pandemic presents an excellent
opportunity to discover more about the potential of the virtual delivery of multidisciplinary rehabilitation to UGI cancer survivors. Although complex to implement given the
multi-component nature of the programme, consultation with
public and patient involvement (PPI) representatives indicates
investigation of delivery of this programme virtually would be
thoroughly welcomed by this patient cohort as the pandemic persists. Accordingly, we will explore this issue through the implementation of a sub-study to the planned ReStOre II RCT entitled
‘ReStOre@Home’ which will be underpinned by the Medical
Research Council (MRC) Framework for evaluating complex
interventions15.
Study aims
The overall aim of this work is to examine the feasibility of
implementing a 12-week multidisciplinary rehabilitation programme consisting of aerobic and resistance exercise, dietary
counselling, and education sessions delivered virtually via
video-conferencing for survivors of UGI cancer.
Feasibility will be determined by the following outcomes;
i)
Recruitment rate
ii)
Adherence rate
iii) Acceptability of the programme
iv)
Retention
v)
Incidents
Secondary aims are:
·
To examine the effect of the
programme on physical functioning.
·
To explore the effect of the ReStOre@Home
programme on dietary quality and nutritional status.
·
To examine the effects of the ReStOre@Home
programme on patient reported outcomes including
HRQOL, and fatigue.
ReStOre@Home
Methods
Study design
ReStOre@Home will be implemented as a single arm,
feasibility study. This feasibility work will be part of a series
of work to complete a process evaluation of ReStOre@Home
underpinned by the MRC framework for evaluating complex
interventions16. Table 1 describes the feasibility/piloting phase
of the MRC Framework alongside the activities involved in
this process evaluation15. Ethical approval has been granted from
the Tallaght University Hospital (TUH)/ St James’s Hospital
(SJH) Ethics Committee. Any amendment to the protocol
which may impact on the conduct of the study will be submitted as an amendment for approval to the ethics committees.
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The study will be performed according to the Declaration of
Helsinki. The flow of participants through the study is depicted
in Figure 1.
Study participants
ReStOre@Home will recruit 12 patients with a histological
confirmed diagnosis of cancer of the oesophagus or stomach
who have undergone surgery with curative intent. Participants
must meet the following eligibility criteria:
·
be ≥ three months post oesophagectomy, total
gastrectomy
·
with or without neo-adjuvant/adjuvant chemo/chemoradiotherapy with curative intent
Table 1. Mapping activities to Medical Research Council (MRC) Framework.
2 Assessing feasibility and piloting methods
2.1
2.2
2.3
Testing procedures for
acceptability, compliance,
and intervention delivery
i.
Testing procedures and intervention prescription previously determined feasible in pilot RCT
work.
ii.
Potential acceptability of telehealth intervention discussed with PPI representatives.
iii.
Assess feasibility of delivering intervention via telehealth in terms of recruitment, retention,
and usability through a pilot with 12 participants.
iv.
Assess acceptability through qualitative interviews.
Estimating recruitment
and retention
i.
Recruitment from a single, national cancer centre.
ii.
Review of literature and engagement with trial methodology groups e.g. Health Research
Board Trial Methodology Research Network (HRB-TMR) and MRC-NIHR Trials Methodology
Research Partnership (TMRP) symposia and working groups to determine best practice for
ongoing retention of participants.
Determining sample size
i.
Sample size for feasibility work based on guidelines by Julious et al.17 re: feasibility studies
and similar feasibility trials in the field of cancer rehabilitation.
ii.
Feasibility results may be used to inform sample size calculation of a future controlled trial.
Figure 1. Study design.
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·
adjuvant therapy must be completed
·
access to home broadband
·
medical clearance to participate
Exclusion criteria are; ongoing serious post-operative morbidity, and evidence of active or recurrent disease. In addition
those with any serious co-morbidity that would impact on exercise participation will be excluded including those with; uncontrolled hypertension (resting systolic blood pressure >180mmHg
and/or diastolic >100mmHg), recent serious cardiovascular
events (within 12 months) including, but not limited to
cerebrovascular accident, and myocardial infarction, unstable cardiac, renal, lung, liver or other severe chronic disease, uncontrolled
atrial fibrillation, and left ventricular function <50%.
Participants will be recruited from one hospital site, SJH
Dublin, the National Centre for Oesophago-gastric Cancer in
Ireland. Participants will be identified at post-operative clinics and through institutional databases by their clinical team.
Eligibility screening will be completed by the clinical team in
conjunction with the research team at SJH. All participants
will require medical clearance prior to enrolment. Participants will continue with all routine care as planned during their
participation in the study. Potentially eligible patients will be
informed about the study by a member of the research team
in person or via telephone and will receive a participant information leaflet. Following a reflection period of 1 week, a
researcher will telephone the patient to confirm their interest in
participation.
As a consequence of the ongoing COVID-19 pandemic those
interested in participating will be required to give initial consent verbally over telephone. Researchers will then schedule
a baseline assessment which will be conducted in the Wellcome
Trust-Health Research Board Clinical Research Facility
(CRF) at SJH. In advance of the assessment as much information as possible will be collected via telephone interview e.g.
background medical history, dietary interview and questionnaires will be provided in advance to minimise face to face
contact. Written informed consent will be obtained during the
baseline assessment (Extended data18).
Intervention
The ReStOre@Home intervention will be delivered virtually through a video-conferencing platform and will follow a
modified version of our established protocol for the ReStOre II
RCT8, the feasibility of which has been previously determined4,6.
The ReStOre@Home programme comprises of three elements: exercise training, individualised dietetic counselling, and
multidisciplinary education. The intervention is summarised in
Figure 2. Coordination of the multicomponent virtual intervention
will be overseen by the project manager, a physiotherapist
experienced in the delivery of multimodal interventions. All
video-conferencing sessions including the group education and
resistance training sessions, and individual goal setting and
dietetic counselling sessions will follow a defined schedule which will be provided to participants at the start of the
intervention.
ReStOre@Home will aim to give participants a greater sense
of self-efficacy over their recovery from UGI cancer, to give
them the belief that they can safely return to physical activity
following their cancer journey, and promote lasting healthy lifestyle changes. This aim is grounded in Social Cognitive Theory
(SCT)19,20 as it considers perceived self-efficacy as a key determinant of health behaviour change. Other core determinants
of the model include; knowledge of health risks, outcome
expectations, and perceived facilitators and impediments of
behaviour20. The design of the ReStOre@Home programme
incorporates each of these core determinants (Figure 3). Key
to the programme is the goal to enhance self-efficacy amongst
participants. This goal will be targeted through enhancing patient
knowledge across the three components of the programme
(exercise, dietary counselling, group education sessions), providing participants with education on the benefits of exercise,
Figure 2. Frequency of ReStOre@Home Sessions.
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Figure 3. Social Cognitive Theory. Figure 3 has been adapted with permission from Bandura A. Health promotion by social cognitive means.
Health Educ Behav. 2004 Apr;31(2):143–64. doi: 10.1177/1090198104263660. PMID: 1509011820.
exercise safety, maintaining a stable body weight, and managing
other symptoms such as fatigue. Outcome expectations will be
derived through the setting of individualised exercise and dietary goals throughout the programme. The programme is also
developed with perceived facilitators and impediments of physical activity in mind. Key facilitators of the programme will
be the clear structure, and a motivated rehabilitation team.
The multidisciplinary nature of the programme will also help
address barriers to activity e.g. fear of weight loss, fatigue etc. to
maximise adherence to the programme.
Aerobic and resistance exercise training. The exercise component will consist of a 12-week programme of aerobic and
resistance programme. Unsupervised aerobic exercise in the
form of walking will be prescribed as per the F.I.T.T (Frequency,
intensity, type and time) principles outlined in the ReStOre II
protocol8, commencing at a low intensity (40–45% heart rate
reserve (HRR)) and progressing to a moderate-vigorous intensity
(65–85% HRR)8. During the ReStOre@Home Programme all
walking sessions will be monitored by the participant’s Polar
Heart Rate Monitor (Polar M200) which will be provided. Participants will grant the research team access to their Polar
Flow account to allow them to monitor their progress. The
physiotherapist will organise a video-conference call check-in
meeting with participants twice weekly for the first month, once
weekly for the second month and once per fortnight for the
final month of the programme. During this meeting the
physiotherapist will perform a subjective assessment to check
in on how the participant is feeling and will review with the
participant how they are doing with the programme, explain
their exercise prescription for the coming days/week, and set
personal goals with the participant.
Resistance exercises will be performed as described in the
ReStOre II RCT protocol8. Participants will complete two sessions of resistance training per week for the duration of the
programme, targeting major muscle groups. Participants will
commence resistance training at a low intensity (16 repetition
max (RM), one set x 12 repetitions) and progress to a higher
intensity of 7RM (4 sets x 6 repetitions). Supervised resistance
training sessions will be held in small online groups (maximum
of 6) with the study physiotherapist via video-conference call.
As per the ReStOre II protocol8 there will be a gradual transition from supervised to independent training as the programme
progress. All participants will be provided with the equipment
necessary to complete the programme at home including free
weights, an aerobic step, resistance bands and a polar heart
rate monitor. Participants will log details of all their exercise
sessions in a logbook.
Dietary counselling. One-to-one dietetic sessions will be
delivered via video-conference calls during week 1, week 2 and
fortnightly thereafter, or more frequently if required. Dietetic
sessions will be delivered by a registered dietitian. As per the
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ReStOre II RCT protocol8 the target for participants undertaking the ReStOre@Home programme will be to optimise dietary
intake, ensuring adequate energy and micronutrient status, in
alignment with international guidelines for cancer survivors21,22.
Multidisciplinary education sessions. Over the 12-week
intervention participants will receive seven group education
sessions via video-conference call which will be delivered by
multidisciplinary team members including a doctor, dietitian,
occupational therapist, and physiotherapist. Group size during
the education component will be limited to six participants per
session to optimise opportunities for peer to peer engagement.
Education topics will include items of concern to UGI cancer
survivors including; self-management, benefits of physical
activity, and fatigue management.
Outcomes
The ReStOre@Home study outcomes are listed in Table 2. The
main assessment battery will be performed at baseline (T0),
and post-intervention (T1).
Table 2. ReStOre@Home Study Outcomes.
Outcome
Instrument
Baseline
Postintervention
T0
T1
Primary outcome
Feasibility
Recruitment rates
Adherence
Acceptability
Secondary outcomes
Aerobic Fitness
Cardiopulmonary Exercise Test
X
X
Functional performance
Short Physical Performance Battery (SPPB)
X
X
Muscle Strength
Hand grip strength (HGS)
X
X
Leg Press 1-RM
X
X
Physical activity
Godin Leisure-Time Exercise Questionnaire
X
X
Body composition
Anthropometry
X
X
Mid arm and waist circumference
Bioimpedance Analysis
X
X
X
X
Dietary interview
X
X
Foodbook24
X
X
Gastrointestinal Symptom Rating Scale (GSRS)
X
X
Simplified Nutritional Appetite Questionnaire (SNAQ)
X
X
Quality of Life
EORTC-QLQ-C30
X
X
Cancer specific quality of Life
EORTC-QLQ-OG25 (oesophago-gastric cancer)
X
X
Fatigue
Multidimensional Fatigue Inventory (MFI-20)
X
X
Qualitative approach
Semi –structured interviews
Dietary intake
Nutrition-related symptoms
X
Other
Sociodemographic details
Participant self-report
X
Medical/Cancer history
Medical records
X
Incidents
Reports of patients/research personnel
X
Satisfaction with Telehealth
Telehealth Usability Questionnaire (TUQ)
Biobank samples
Blood samples
X
X
X
X
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Primary outcome – feasibility. This study will focus on the
feasibility/ piloting phase of the MRC framework for process evaluation16. Feasibility of the ReStOre@Home intervention will be described in terms of recruitment rates, adherence,
retention, acceptability of the programme and incidents. Recruitment rate will be defined as the percentage of eligible study
population whom consent to participation. In line with the
ReStOre II trial protocol8, adherence will be recorded according to a comprehensive battery of outcomes including number of
completed sessions, permanent treatment discontinuation, treatment interruption, dose modification, early session termination,
and pre-treatment intensity modification (Table 3), consistent
with recommended practice for clinical exercise trials23. A
number of sources will be used to calculate adherence including;
participants polar heart rate data, participants logbook of exercise completed, and the physiotherapist’s records of supervised
sessions. Retention will be defined as the percentage of enrolled
participants completing the post-intervention assessment.
Acceptability of the intervention will be determined through the
use of qualitative interviews and completion of the Telehealth
Usability Questionnaire (TUQ)24 post-intervention. Incidents
will be recorded throughout the study period.
Feasibility will be further examined using a qualitative
approach, wherein the acceptability of delivering the programme virtually will be explored along with participant’s perceptions of the impact of the ReStOre@Home programme on
their physical and mental well-being. Data will be collected
through semi-structured individual interviews immediately
post-intervention (T1) by a researcher experienced in qualitative
methods. Interviews will be held via telephone/video-conference
call and will be recorded. The discussion guide (Extended
data18) will explore recommendations for future delivery of the
programme through telehealth and the impact of the programme
on overall health and wellbeing. Interview recordings will
be transcribed and analysed using thematic analysis25.
Secondary outcomes. Secondary outcomes will investigate the
preliminary efficacy of the ReStOre@Home intervention, by
examining the impact of the intervention on physical functioning, dietary adequacy and nutritional status, health related quality of life, and fatigue. The feasibility of utilising these measures
in this cohort was previously established in the ReStOre I
feasibility study and pilot RCT4,6. Physical functioning will be
examined using a suite of validated measures examining aerobic
fitness, functional performance, muscle strength, physical activity and body composition. Aerobic fitness will be determined
by Cardiopulmonary Exercise Test (CPET). The CPET procedure will be performed as outlined in the ReStOre II protocol8.
An antibacterial/antiviral filter will be installed in the CPET
circuit to minimise infection risk by reducing the amount of
droplet aerosol dispersion in the air mitigating the contamination of the environment during testing. Functional performance
will be captured using the Short Physical Performance Battery26.
Muscle strength will be assessed by handheld dynamometry
and a 1-RM leg press test. Hand grip strength (HGS) provides a
measure of hand and forearm strength and is found to correlate
well with overall muscle strength and physical function27. The
1-RM leg-press test will be performed as per the ReStOre II
trial protocol8. Physical activity levels will be measured by the
Godin Leisure-Time Exercise Questionnaire, a validated tool for
determining physical activity levels in cancer survivors28. Weight
(kilogrammes (kg)) and height (centimetres (cm)) will be
recorded by standard methods and body mass index (BMI) will
be calculated as weight (kg)/ height (metres (m2)). Mid-arm
muscle circumference and waist circumference will be measured in centimetres with a flexible measuring tape. Measurements will be taken in duplicate and averaged for data entry.
Bioimpedance analysis (BIA) will be performed using Seca
mBCA 515 (Seca, Hamburg, Germany).
Dietary adequacy and nutrition related symptoms will be
assessed by the trial dietitian at T0 and T1 using a structured
Table 3. Exercise Adherence variables.
Variable
Definition
Total number of supervised sessions attended
Total number of scheduled programme sessions attended on video call.
Total number of unsupervised sessions completed
Total number of unsupervised sessions reported in exercise diary as complete
Total number of compliant aerobic sessions
completed
Total number of aerobic sessions where prescribed aerobic exercise dosage was
achieved
Total number of compliant resistance sessions
Total number of resistance sessions where prescribed resistance training dosage
was achieved
Permanent treatment discontinuation
Permanent discontinuation of the ReStOre@Home programme before week 12
Treatment interruption
Missing at least three consecutive ReStOre@Home supervised resistance training
sessions
Dose modification
Number of videocall supervised sessions requiring exercise dose modification
Early session termination
Number of videocall supervised sessions requiring early session termination
Pre-treatment intensity modification
Number of videocall supervised sessions requiring modification because of a preexercise screening indication.
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dietary interview. In addition participants will also complete
Foodbook 2429, the Gastrointestinal Symptom Rating Scale
(GSRS)30 and the Simplified Nutritional Appetite Questionnaire
(SNAQ)31. Health Related Quality of Life (HRQOL) will be
determined by the European Organisation for Research and
Treatment of Cancer Quality of Life Questionnaire (EORTCQLQ-C30 version 3.0)32 and the oesophago-gastric cancer specific
subscale (EORTC-QLQ-OG25). Fatigue will be assessed using
the Multidimensional Fatigue Inventory (MFI-20).
Biosample collection. As per the ReStOre II RCT8 participants
will be invited to consent to donating samples to the Upper
Gastrointestinal Cancer Survivorship Biobank (Extended data18).
Serum, plasma, and whole blood samples will be collected
from consenting participants at T0 and T1. Samples will be
processed and stored at -80°C at the Trinity Translational
Medicine Institute, St James’s Hospital, Dublin 8 for future
analyses to explore the impact of multidisciplinary rehabilitation
in survivorship on key biomarkers.
Safety
All incidents will be recorded, and serious incidents will be
reported to the research ethics committee. Prior to baseline
testing, all participants will require medical approval confirming their suitability for participation. Weight loss is a concern
for UGI cancer survivors, and accordingly the study dietitian will monitor weight closely during the ReStOre@Home
programme.
In light of the current pandemic additional measures to enhance
safety will be implemented. All participants will be screened
for signs and symptoms of COVID-19 via telephone by the
research team the day before their assessments in the CRF
at SJH. Participants will be screened again on the day of their
assessment upon arrival at the CRF to confirm the participant
and all individuals in their household are free from symptoms
of COVID-19. All research staff will follow the COVID-19
National Protocol for workers and will not present themselves
for work if symptomatic. Research staff will be fully equipped
with alcohol hand gel, PPE and cleaning products and will
receive training in how to use all correctly. As much of the
assessment battery will be performed over the phone in advance
of study assessments to minimise face to face contact time.
Questionnaires will be provided via post to participants in
advance of their assessment to further reduce face to face contact
time. During the assessment in the CRF participants will be
required to don a mask and clean their hands upon arrival
and research staff will don appropriate PPE including a
facemask, and goggles, and maintain physical distancing as
much as possible. As the intervention will be delivered completely
in participants homes, participants will be provided with the
ReStOre@Home Exercising at Home Advice Sheet (Extended
data18) educating them on normal and abnormal responses
to exercise and what they should do if they experience an
abnormal response.
Statistical considerations
Sample size calculation. A sample of 12 participants will be
recruited to determine the feasibility of the ReStOre@Home
programme. This is based on the recommendations of Julious
et al.17 whom recommend a minimum sample size of 12 per
group as a rule of thumb and justifies this based on rationale
about feasibility and precision about the mean and variance33,
in order to inform future quantitative studies. Similar sample
sizes have been utilised in other rehabilitation trials in cancer
survivorship4,5,34–37.
Data management and analysis. The Data Management
Plan (Extended data18) will outline how research data will be
handled during and after the project. The data management
plan is a live document and will be reviewed regularly throughout the study. Source documents for this study will include
hospital records, procedure reports and data collection forms.
Outcome assessments will be recorded in a paper-based case
report form. Data from the case report form will then be entered
into a password protected computer data repository. Data
validation will be used to avoid erroneous data entry. All participants will be allocated a unique study code. The key to the
study code will be stored securely and separately. All paper
records will be stored in locked filing cabinets, in a locked office
in a restricted access building with swipe access. Electronic
records will be stored on password protected encrypted
devices. Upon completion of the trial an anonymised data set
will be deposited on a secure online repository in line with open
access publication requirements.
Quantitative data analysis will be performed using IBM SPSS
Statistics 26 software, employing statistical best practice. An
inspection of patient characteristics at baseline will be carried
out. Summary statistics for continuous variables (means and
standard deviations or median and ranges as appropriate) and
categorical variables (counts and proportions) will be presented.
A qualitative descriptive approach38 will be taken to the analysis of qualitative data. Braun and Clarke’s25 6 stage approach
to thematic analysis will be used to analyse all data collected
by a team of researchers using nVivo 12 (QSR International,
Australia).
Trial management and governance
The management of this feasibility study will be overseen by
the ReStOre II trial management groups; a Trial management
Group (TMG), Trial Steering Committee (TSC) and an
Independent Data Monitoring Committee (IDMC).
)
Dissemination
The results of the ReStOre@Home feasibility study will be
disseminated via peer-reviewed publications and conference
presentations. Upon completion of the trial an anonymised
data set will be deposited on a secure online repository in line
with open access publication requirements.
Study status
Recruitment will begin in Winter 2020.
Ethical statement
Ethical approval has been granted by the TUH/SJH Research
Ethics Committee (REC: 2020-07 List- Amendment (23)). Any
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HRB Open Research 2020, 3:86 Last updated: 14 MAY 2021
modifications to this planned protocol will be reported to the
ethics committee.
The study was registered with ClinicalTrials.gov on 26th
October 2020 (NCT04603339).
Discussion
In the absence of an effective vaccine, the COVID-19
pandemic is likely to persist into the medium term. Whilst society continues to grapple with living with COVID-19, implementation of much needed rehabilitative programmes to people
living with and beyond cancer in a face to face manner will
continue to be extremely challenging due to public health
restrictions and the valid fear experienced by vulnerable cancer
survivors of attending face to face appointments in health care
environments. To this end, never has the virtual delivery of
rehabilitation to cancer survivors within their homes had such
potential.
Implementing a complex multicomponent intervention virtually will not be without its challenges. Whilst existing evidence
supports the implementation of single component virtual programmes such as online exercise classes, there is however
emerging evidence to support the virtual delivery of other
multi-component rehabilitation programmes in chronic disease management. Of note virtually delivered pulmonary rehabilitation programmes consisting of exercise, education, and
self-management support has been found to be feasible, safe
and result in equivalent clinical gains in comparison to face to
face delivery39 however the application of these results to other
multimodal rehabilitation programmes, particularly those combining different individual interventions, is unknown and
requires investigation. Successful implementation of the
ReStOre@Home feasibility study would indicate the need to
continue the process evaluation of the ReStOre@Home programme by RCT to assess its effectiveness. In the future ReStOre@
Home may potentially provide a viable alternative template
for delivery of the ReStOre II programme to vulnerable patients
who are cocooning or shielding in their homes, or those who
would be otherwise unable to participate due to time constraints,
or travel restrictions.
Data availability
Underlying data
No data are associated with article.
Extended data
Open Science Framework: ReStOre@Home: Feasibility study
of a virtually delivered 12-week multidisciplinary rehabilitation
programme for survivors of upper gastrointestinal (UGI) cancer:
Study Protocol https://doi.org/10.17605/OSF.IO/EYV3M
This project contains the following extended data:
- ReStOre@Home Interview Guide Version 1.pdf (Focus
group/interview guide)
-
ReStOre@Home SJH Consent Form Version 1.pdf (Consent
form)
-
200908 PIL_ICF_V1_Upper GI Surviorship Biobank
ReStOre@Home.pdf (Biobank PIL and Consent Form)
-
Data Management Plan (DMP) Version 1 RESTORE@
HOME.pdf (Data Management Plan)
-
ReStOre@Home Exercising at Home Advice Sheet.pdf
(ReStOre@Home Exercising at Home Advice Sheet)
-
200626 ReStOre@Home Participant Logbook Version
1.pdf (Exercise session logbook)
Reporting guidelines
Open Science Framework: SPIRIT checklist for ‘ReStOre@
Home: Feasibility study of a virtually delivered 12-week
multidisciplinary rehabilitation programme for survivors of
upper gastrointestinal (UGI) cancer - study protocol’ https://doi.
org/10.17605/OSF.IO/EYV3M
Data are available under the terms of the Creative Commons
Attribution 1.0 Universal license (CC0 1.0).
Acknowledgments
The authors would like to acknowledge the assistance and
support of the Wellcome Trust/Health Research Board Clinical Research Facility at St. James’ Hospital, Dublin. The authors
greatly acknowledge the ongoing support of our charity partners the Irish Cancer Society and the Oesophageal Cancer Fund,
and of our patient and public representatives. The authors would
like to thank our infrastructural partners, the Health Research
Board Trials Methodology Research Network (HRB-TMRN)
for their support with this project.
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Open Peer Review
Current Peer Review Status:
Version 1
Reviewer Report 22 March 2021
https://doi.org/10.21956/hrbopenres.14318.r29019
© 2021 Forbes C. This is an open access peer review report distributed under the terms of the Creative Commons
Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the
original work is properly cited.
Cynthia Forbes
Wolfson Palliative Care Research Centre, Institute of Clinical and Applied Health Research,
University of Hull, Hull, UK
This article describes a study protocol for the modified version of a previously planned feasibility
RCT to deliver a multi-component rehabilitation programme to upper GI cancer survivors.
Feasibility for the in-person programme has been conducted and a larger trial was planned, now
on hold due to the pandemic. In order to explore remote delivery, the authors have modified the
protocol for video conference delivery.
Comments
A few question arose as I was reading, some of which were answered by the previous protocol.
Is there a minimum and maximum time for the counselling, education, and exercise sessions?
Study design: I say partly because the sample is too small to really estimate SD for a sample size
calculation. Many sources call for minimum 30 participants for this kind of study. 12 may even be
too few to reach saturation for the qualitative follow-up. Understandably, this may be a difficult
population to recruit but I think this needs to be very clear. Subsequently, the secondary
outcomes should be highlighted more so as exploratory.
Do all people start the programme at the same time? With only 12, this may be feasible but I
wondered how you would schedule these sessions.
You mention having smaller groups for certain sessions. Will the groups always be the same
people or will it be different each time?
Access to broadband is essential but how will you deal with different levels of competence and
grades of equipment? Will you exclude based on equipment availability, i.e. if someone doesn’t
have a webcam, can they participate in sessions with a smartphone?
Is the rationale for, and objectives of, the study clearly described?
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Yes
Is the study design appropriate for the research question?
Partly
Are sufficient details of the methods provided to allow replication by others?
Yes
Are the datasets clearly presented in a useable and accessible format?
Not applicable
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Cancer rehabilitation, digital technology.
I confirm that I have read this submission and believe that I have an appropriate level of
expertise to confirm that it is of an acceptable scientific standard, however I have
significant reservations, as outlined above.
Author Response 11 Apr 2021
Linda O'Neill, Trinity College Dublin, the University of Dublin, Dublin, Ireland
Dear Professor Forbes,
On behalf of the authorship I wish to thank you for taking the time to review our manuscript
and for your constructive feedback. Please see below our responses to your comments.
1. A few questions arose as I was reading, some of which were answered by the
previous protocol.
2. Is there a minimum and maximum time for the counselling, education, and exercise
sessions?
Response:
Thank you for your helpful feedback.
Group education sessions will be a maximum of one hour. Group resistance training
sessions will last approx. 30-40 minutes. 1:1 phone calls will last 30 minutes, apart from the
first call which may be longer as participants may have additional questions.
The following statement has been added to the ‘Intervention’ section of the manuscript:
“Group education sessions will last a maximum of one hour; check-in meetings and group
resistance training will last approximately 30 minutes.”
3. Study design: I say partly because the sample is too small to really estimate SD for a
sample size calculation. Many sources call for minimum 30 participants for this kind of
study. 12 may even be too few to reach saturation for the qualitative follow-up.
Understandably, this may be a difficult population to recruit but I think this needs to
be very clear. Subsequently, the secondary outcomes should be highlighted more so
as exploratory.
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Response:
Thank you for this feedback. To reinforce that secondary outcomes are exploratory only, the
following statement has been included in the ‘Outcomes’ section:
“These outcomes are exploratory only as the sample size is not sufficient to demonstrate
treatment effect.”
We have carefully considered your comments regarding the sample size. We believe a
sample size of 12 will provide sufficient data for the qualitative interviews. In accordance
with recommendations from Fusch et al., we will apply specific measures to ensure the best
chance of reaching data saturation: use of saturation grid, two-party coding of transcripts,
and suitably-designed interview guides. We understand that, will well-conducted interview,
data saturation can be achieved with 12 participants.
4. Do all people start the programme at the same time? With only 12, this may be
feasible but I wondered how you would schedule these sessions.
Response:
We aim to have two groups of six participants. Depending on recruitment rates, these two
groups may be run at the same time or one after another; either way, they will operate
separately to ensure that the groups of six have the opportunity to develop familiarity and
social connections.
5. You mention having smaller groups for certain sessions. Will the groups always be
the same people or will it be different each time?
Response:
The groups of six will be the same participants each time.
6. Access to broadband is essential but how will you deal with different levels of
competence and grades of equipment? Will you exclude based on equipment
availability, i.e. if someone doesn’t have a webcam, can they participate in sessions
with a smartphone?
Response:
Participants will be welcome to join the online sessions on any device which has a webcam
(desktop, laptop, tablet, smartphone). We will have opportunities to ensure they are familiar
with the technology and provide tutorials or explanations at recruitment, assessment and
during check-in calls. We will also provide each participant with ‘how-to’ information leaflets
for the video-conferencing software and for the heart rate monitor.
We hope that you find our response to your comments satisfactory and look forward to
hearing from you.
Kind regards,
Dr Linda O'Neill
References
Fusch P, Ness L. Are we there yet? Data saturation in qualitative research. Qual Rep.
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2015;20(9):1409-1416. doi:10.1177/1049732311401424
Competing Interests: The authorship have no competing interests to disclose
Reviewer Report 01 February 2021
https://doi.org/10.21956/hrbopenres.14318.r28448
© 2021 Denehy L et al. This is an open access peer review report distributed under the terms of the Creative
Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium,
provided the original work is properly cited.
Lara Edbrooke
University of Melbourne, Melbourne, Australia
Linda Denehy
Melbourne School of Health Sciences, University of Melbourne, Melbourne, Australia
Thank you for the opportunity to review this well written protocol paper involving 12 weeks of
'virtual' rehabilitation for patients following treatment for oesophago-gastric cancer. This work is a
sub study of an ongoing randomised controlled trial the ReStOre II RCT (NCT03958019) providing
rehabilitation face to face for which the protocol is already published. The virtual program aims to
establish the feasibility and safety of multi-disciplinary rehabilitation, including exercise, nutrition
support and education, delivered entirely remotely.
Given the impact the COVID-19 pandemic has had on traditional face-to-face models of
rehabilitation delivery and taking into account rural or remote survivors who have limited access
to services, work in this area is timely and of critical importance.
The protocol is well written and clear and generally reproducible. Following review of the
manuscript we have the following questions and comments for the authors:
1. Despite the justification references used for the sample size, I am not convinced that n=12
would provide enough patients to be representative of the target study population for using
telehealth rehabilitation methods. The authors should remove the statement on page 9
that….’similar sample sizes have been used in in other rehabilitation trials in cancer’ This is
not a scientific justification of sample size. Thabane et al. 2010 in A tutorial on pilot studies:
what, why and how provide a simple confidence interval approach to estimating samples to
establish feasibility1. Additionally, I don’t believe that 12 patients will provide enough
information on efficacy and variance estimates for the battery of outcome measures to
estimate treatment effects in future trials and may lead to biased or unrealistic estimates.
Further, the authors should keep in mind the impact that the COVID-19 pandemic could
potentially have on the outcomes collected, including CPET, physical activity levels and
health-related quality of life and caution against the use of these data for powering future
trials.
2. This is a sub study of the larger RESTORE RCT. It is not documented how recruitment will
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work alongside the larger RCT at the one hospital site? This is important to ensure that bias
is not introduced if patients have a choice or are not sequentially offered to participate in
this smaller virtual sub study. Please add.
3. What cut-points will be used for the proportion of eligible patients recruited, adherence to
intervention sessions and outcome assessments to guide whether implementing the
intervention is feasible? Please add to aims/hypotheses.
4. If the baseline SPPB indicates balance impairments will participants still be prescribed
outdoor walking or is loan of a stationary cycle for aerobic exercise possible? Please add to
method.
5. Will participants be provided with equipment (bike/treadmill) in the event that walking
outdoors is limited by government COVID-19 restrictions? Our recent experience is that
participants may be wary of walking outdoors given the current situation. A suggestion.
6. The authors state one of the key aims of the programme is to increase participants’ selfefficacy over their recovery – the authors could consider including a patient-reported selfefficacy questionnaire to assess this. It would also strengthen the study to have an objective
measure of physical activity using accelerometry, in addition to the use of the Godin Leisure
Time Exercise questionnaire. A suggestion.
7. The authors state and Figure 2 highlights that this is a complex intervention. Will weekly
video calls from the dietitian, the physiotherapist and group education sessions be coordinated/performed in conjunction to reduce the burden on participants of multiple
weekly contacts? Please ad to method.
8. It is not clear (or may have missed it) if all outcome measures are being performed at the
hospital? Clearly CPET would be but for others there is potential to undertake these
remotely as well? This should be made clear.
References
1. Thabane L, Ma J, Chu R, Cheng J, et al.: A tutorial on pilot studies: the what, why and how.BMC
Med Res Methodol. 2010; 10: 1 PubMed Abstract | Publisher Full Text
Is the rationale for, and objectives of, the study clearly described?
Yes
Is the study design appropriate for the research question?
Partly
Are sufficient details of the methods provided to allow replication by others?
Partly
Are the datasets clearly presented in a useable and accessible format?
Not applicable
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Competing Interests: No competing interests were disclosed.
Reviewer Expertise: My research is focused on physiotherapy rehabilitation in acute care settings
including critical care, pre and post surgery and oncology.
We confirm that we have read this submission and believe that we have an appropriate level
of expertise to confirm that it is of an acceptable scientific standard, however we have
significant reservations, as outlined above.
Author Response 11 Apr 2021
Linda O'Neill, Trinity College Dublin, the University of Dublin, Dublin, Ireland
Dear Professor Edbroke and Professor Denehy,
On behalf of the authorship I would like to thank you both for taking the time to review our
paper and for your constructive feedback. Please see below our response to your
comments.
1. Despite the justification references used for the sample size, I am not convinced
that n=12 would provide enough patients to be representative of the target study
population for using telehealth rehabilitation methods.
The authors should remove the statement on page 9 that….’similar sample sizes have
been used in in other rehabilitation trials in cancer’ This is not a scientific justification
of sample size. Thabane et al. 2010 in A tutorial on pilot studies: what, why and how
provide a simple confidence interval approach to estimating samples to establish
feasibility1.
Additionally, I don’t believe that 12 patients will provide enough information on
efficacy and variance estimates for the battery of outcome measures to estimate
treatment effects in future trials and may lead to biased or unrealistic estimates.
Further, the authors should keep in mind the impact that the COVID-19 pandemic
could potentially have on the outcomes collected, including CPET, physical activity
levels and health-related quality of life and caution against the use of these data for
powering future trials.
Response:
Thank you for your thorough and helpful feedback.
The statement on page 9 has been removed.
We have carefully considered your comments regarding the sample size. We acknowledge
the sample size is small in comparison to many other feasibility studies. The target study
population is wide, covering a variety of ages, genders, levels of impairments and socioeconomic backgrounds. It will certainly be difficult to fully represent this population in a
feasibility study, and our randomised control trials in this population will more effectively
reflect the broader population. The characteristics of the sample as a reflection of the target
population will be discussed in the manuscript for publication and will be acknowledged as
a limitation of it is under-representative of the target population.
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We wish to emphasise that the primary aim of this study is to examine the feasibility of
implementing the ReStOre programme virtually using video-conferencing software.
Therefore, the main aspects of feasibility we will explore are related to how the programme
translates to a virtual rehabilitation setting. We believe a sample size of 12 will provide
sufficient data for the feasibility outcomes of recruitment, adherence, acceptability,
retention and adverse incidents, as well as qualitative interviews and the telehealth usability
questionnaire.
• No minimum sample size is required for the Telehealth Usability Questionnaire
(Parmanto et al. 2016).
• In interview-based studies, data saturation can be achieved with 12 interviews (Guest et
al. 2006). In accordance with recommendations from Fusch et al. (2015), we will apply
specific measures to ensure the best chance of reaching data saturation: use of saturation
grid, two-party coding of transcripts, and suitably designed interview guides.
As described in the paper’s introduction, the feasibility and effectiveness of the ReStOre
programme has already been evaluated in an in-person setting, with both a feasibility study
and a pilot randomised controlled trial. Regarding the information needed to estimate
treatment effects in future trials, the pilot study and RCT with the ReStOre programme will
assist greatly in providing this information, and it will not solely be acquired from this
feasibility study. To communicate more clearly that the secondary outcomes are exploratory
only and we do not aim to derive treatment effects from this data, we have included the
following statement has been in the ‘Outcomes’ section:
“These outcomes are exploratory only as the sample size is not sufficient to demonstrate
treatment effect.”
As you have highlighted, the secondary outcomes of CPET, physical activity levels and
health-related quality of life may be influenced by the government-enforced restrictions,
personal decisions to ‘cocoon’ and subsequently reduce physical activity, or indeed by the
effects of the disease itself. To understand the effects of the COVID-19 pandemic on
participants, we will include the following question on the interview guide:
“How do you feel your health, fitness and overall wellbeing has been impacted by the
COVID-19 pandemic and the restrictions imposed over the last year?”
In addition, the potential influence of Covid-19 restrictions on secondary outcomes for this
study will be highlighted as limitations in future manuscripts detailing the study results.
2.This is a sub study of the larger RESTORE RCT. It is not documented how recruitment
will work alongside the larger RCT at the one hospital site? This is important to ensure
that bias is not introduced if patients have a choice or are not sequentially offered to
participate in this smaller virtual sub study. Please add.
Response:
The main RCT is currently on hold due to the COVID-19 pandemic. Ireland continues to
experience high numbers of cases and exercising in groups has not been permitted for over
one year. Therefore, recruitment for both trials will not be happening at the same time. We
aim to commence recruitment for ReStOre@Home in May 2021 and for ReStOre II after the
summer, when, hopefully, the wider population is vaccinated and a return to group exercise
is permitted.
The following statement has been included in the ‘Study Participants’ section:
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“Recruitment for ReStOre@Home will not occur at the same time as recruitment for the
main ReStOre RCT.”
3. What cut-points will be used for the proportion of eligible patients recruited,
adherence to intervention sessions and outcome assessments to guide whether
implementing the intervention is feasible? Please add to aims/hypotheses.
Response:
Cut-points will be as follows:
Proportion of eligible patients recruited: 50%
○
Adherence to intervention sessions: mean of 80% adherence to supervised sessions,
70% adherence to unsupervised sessions.
Attendance of assessment sessions (expressed in paper as ‘retention’): 100%
attendance at T0, 83% attendance at T1
The following statement has been included in the Outcomes section:
“Feasibility to proceed to a definitive trial of ReStOre@Home will be determined by
considering all the above factors, and the specific achievement of the following criteria:
≥50% of eligible patients recruited; mean of ≥80% adherence to supervised exercise
sessions and ≥70% adherence to unsupervised sessions; ≥83% attendance at T1
assessment.”
○
○
4. If the baseline SPPB indicates balance impairments will participants still be
prescribed outdoor walking or is loan of a stationary cycle for aerobic exercise
possible? Please add to method.
If researchers find that a participant has a balance impairment which would make it
unsafe to walk outdoors, they will not be included in the study. By clearly identifying
in the participant information leaflet and in recruitment discussions that a core
component of this study is outdoors walking, we think it is unlikely that a participant
will be excluded at assessment for this reason.
Response:
The following statement has been added to the ‘Study Participants’ section:
“If there are any findings at assessment which indicate that a person is unsafe to exercise,
they will not proceed with the intervention phase of the study.”
5. Will participants be provided with equipment (bike/treadmill) in the event that
walking outdoors is limited by government COVID-19 restrictions? Our recent
experience is that participants may be wary of walking outdoors given the current
situation. A suggestion.
Response:
Walking outdoors has been permitted in Ireland throughout the pandemic, and has even
been encouraged by the government, with city and county councils providing specific hours
for vulnerable individuals to have preferential use of local parks. We will discuss
participant’s levels of comfort around walking outdoors and provide safety advice such as
wearing a mask and avoiding exercising outdoor in times where parks and pavements are
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busy. Unfortunately, we do not currently have the means to loan home exercise equipment.
6. The authors state one of the key aims of the programme is to increase
participants’ self-efficacy over their recovery – the authors could consider including a
patient-reported self-efficacy questionnaire to assess this. It would also strengthen
the study to have an objective measure of physical activity using accelerometry, in
addition to the use of the Godin Leisure Time Exercise questionnaire. A suggestion.
Response:
Thank you for these two helpful suggestions. We aim to examine changes in self-efficacy
through the qualitative interviews, however on reflection we can see that the study will
benefit from this being addressed more explicitly. We have therefore added the following
questions to the interview guide, which directly explore self-efficacy concepts:
“Have you noticed any changes in your confidence, specifically around being able to do the
things that are important to you? How do you feel now about starting or completing
something (a task or personal goal) that you find challenging?”
We have chosen not to use an accelerometer because, as physical activity is not a main
outcome of the study, objectively measuring physical activity is not a priority in this
feasibility trial. Additionally, as participants will be using videoconferencing software as well
as the heart rate monitor and its associated smartphone app, we feel this is already a lot of
novel technologies for this population and do not wish to over-burden them from a
technological perspective. The results from this study will inform the feasibility of using
additional wearable technology in future studies.
7. The authors state and Figure 2 highlights that this is a complex intervention. Will
weekly video calls from the dietitian, the physiotherapist and group education
sessions be co-ordinated/performed in conjunction to reduce the burden on
participants of multiple weekly contacts? Please add to method.
Response:
Video calls and sessions will be scheduled to suit participant’s personal commitments, and,
as much as possible, will be grouped together and scheduled at the same time each week.
This will be achieved as follows: at recruitment, researchers will ask participants what times
and days suit best for attending sessions online and, with this information, a 12-week
timetable will be generated for each participant and provided at the start of the
intervention. Group sessions (strength training, education) will be at the same time each
week. We aim to run 1:1 sessions directly before or after group sessions as able, but this will
not always be possible due to staffing numbers. Participants can alter 1:1 sessions on the
timetable by consulting the study physiotherapist or dietician as needed.
The following statement has been added to the ‘Intervention’ section:
“To ensure the schedule is acceptable to each participant, group sessions will be planned for
the same time each week and 1:1 sessions will be scheduled at times chosen by
participants.”
8. It is not clear (or may have missed it) if all outcome measures are being performed
at the hospital? Clearly CPET would be but for others there is potential to undertake
these remotely as well? This should be made clear.
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Response:
This is detailed in the ‘Study Participants’ section as follows:
“In advance of the assessment as much information as possible will be collected via
telephone interview e.g. background medical history, dietary interview and questionnaires
will be provided in advance to minimise face to face contact.”
We hope that you find the above changes to the manuscript satisfactory.
Kindest regards,
Dr Linda O'Neill
Competing Interests: The authorship have no competing interests to declare.
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