See Appendix A for the complete list of the IDES_2 Investigators; Appendix B for the SPIRIT 2013 ... more See Appendix A for the complete list of the IDES_2 Investigators; Appendix B for the SPIRIT 2013 Checklist; Appendix C for Forms and Questionnaires; and Appendix D for World Health Organization Trial Registration Data Set. (DOC 252 kb)
Introduction Type 2 diabetes (T2D) is associated with an increased fracture risk despite normal-t... more Introduction Type 2 diabetes (T2D) is associated with an increased fracture risk despite normal-to-increased bone mineral density, suggesting reduced bone quality. Exercise may be effective in reducing fracture risk by ameliorating muscle dysfunction and reducing risk of fall, though it is unclear whether it can improve bone quality. Methods and analysis The ‘Study to Weigh the Effect of Exercise Training on BONE quality and strength (SWEET BONE) in T2D’ is an open-label, assessor-blinded, randomised clinical trial comparing an exercise training programme of 2-year duration, specifically designed for improving bone quality and strength, with standard care in T2D individuals. Two hundred T2D patients aged 65–75 years will be randomised 1:1 to supervised exercise training or standard care, stratified by gender, age ≤ or >70 years and non-insulin or insulin treatment. The intervention consists of two weekly supervised sessions, each starting with 5 min of warm-up, followed by 20 min...
Background Psychological well-being and quality of life (QoL) are important outcomes of lifestyle... more Background Psychological well-being and quality of life (QoL) are important outcomes of lifestyle interventions, as a positive impact may favour long-term maintenance of behaviour change. Objective This study investigated the effect of a behavioural intervention for adopting and maintaining an active lifestyle on psychological well-being and health-related QoL in individuals with type 2 diabetes. Methods Three hundred physically inactive and sedentary patients were randomized 1:1 to receive 1 month’s theoretical and practical counselling once a year (intervention group, INT) or standard care (control group, CON) for 3 years. Psychological well-being and QoL, assessed using the World Health Organization (WHO)-5 and the 36-Item Short Form (SF-36) questionnaire, respectively, were pre-specified secondary endpoints. The primary endpoint was sustained behaviour change, as assessed by accelerometer-based measurement of physical activity (PA) and sedentary time. Results WHO-5 and SF-36 phy...
Objective. Quantitative ultrasound (QUS) provides an estimate of bone mineral density (BMD) and a... more Objective. Quantitative ultrasound (QUS) provides an estimate of bone mineral density (BMD) and also evaluates bone quality, which has been related to increased fracture risk in people with diabetes. This study aimed at assessing the correlates of calcaneal QUS parameters in diabetic subjects encompassing various degrees of micro and macrovascular complications and a wide-range of peripheral nerve function. Methods. Four hundred consecutive diabetic patients were examined by QUS to obtain values of broadband ultrasound attenuation (BUA), the speed of sound (SOS), quantitative ultrasound index (QUI), and BMD. Results. Among surrogate measures of complications, sensory and motor nerve amplitude and heart rate response to cough test and standing correlated with QUS parameters at univariate analysis, together with age, body mass index (BMI), waist circumference, lipid profile, and renal function. Multivariate analysis revealed that BUA, SOS, QUI, and BMD were independently associated wi...
OBJECTIVE Adherence to physical activity (PA) recommendations is hampered by the lack of effectiv... more OBJECTIVE Adherence to physical activity (PA) recommendations is hampered by the lack of effective strategies to promote behavior change. The Italian Diabetes and Exercise Study 2 (IDES_2) is a randomized controlled trial evaluating a novel behavioral intervention strategy for increasing PA and decreasing sedentary time (SED-time) in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS The study randomized 300 physically inactive and sedentary patients with type 2 diabetes 1:1 to receive theoretical and practical counseling once yearly for 3 years (intervention group [INT]) or standard care (control group [CON]). Here, we report the 4-month effects on objectively (accelerometer) measured daily light-intensity PA (LPA), moderate-to-vigorous–intensity PA (MVPA), and SED-time, and cardiovascular risk factors. RESULTS LPA and MVPA both increased, and SED-time decreased in both groups, although changes were significantly more marked in INT participants (approximately twofold for LP...
Musculoskeletal disorders are common in subjects with type 2 diabetes mellitus (T2DM) and may rep... more Musculoskeletal disorders are common in subjects with type 2 diabetes mellitus (T2DM) and may represent a barrier to physical activity (PA). In the Italian Diabetes and Exercise Study, we assessed whether a strategy aimed at minimizing the risk of injury and worsening of musculoskeletal symptoms favors participation in exercise training and results in improvements in joint-specific functional scores, along with amelioration of metabolic profile. Sedentary patients with T2DM (n = 606) from 22 outpatient diabetes clinics were randomized to twice-a-week supervised aerobic and resistance training plus exercise counseling (EXE) versus counseling alone (CON) for 12 months. Musculoskeletal symptoms were evaluated at baseline in the entire cohort by the use of a self-reported questionnaire in order to design tailored exercise programs with exclusion of painful segments, and validated joint-specific scores were calculated at the end of study in a subgroup of CON (n = 65) and EXE subjects (n = 62). Musculoskeletal symptoms were present in more than ¾ of EXE and CON subjects. Yet, volumes of non-supervised PA were high, whereas dropout rates and adverse events were low in both groups. Moreover, in the EXE group, no difference was observed between patients with and without symptoms in session attendance and PA/exercise volume. Scores for symptoms and functional status of limbs and spine were significantly better in EXE than in CON subjects and correlated with PA/exercise volume and improvements in fitness parameters. Preliminary evaluation of musculoskeletal symptoms is useful in favoring compliance with supervised training programs and obtaining significant benefits to the functional status of the involved joints.
See Appendix A for the complete list of the IDES_2 Investigators; Appendix B for the SPIRIT 2013 ... more See Appendix A for the complete list of the IDES_2 Investigators; Appendix B for the SPIRIT 2013 Checklist; Appendix C for Forms and Questionnaires; and Appendix D for World Health Organization Trial Registration Data Set. (DOC 252 kb)
Introduction Type 2 diabetes (T2D) is associated with an increased fracture risk despite normal-t... more Introduction Type 2 diabetes (T2D) is associated with an increased fracture risk despite normal-to-increased bone mineral density, suggesting reduced bone quality. Exercise may be effective in reducing fracture risk by ameliorating muscle dysfunction and reducing risk of fall, though it is unclear whether it can improve bone quality. Methods and analysis The ‘Study to Weigh the Effect of Exercise Training on BONE quality and strength (SWEET BONE) in T2D’ is an open-label, assessor-blinded, randomised clinical trial comparing an exercise training programme of 2-year duration, specifically designed for improving bone quality and strength, with standard care in T2D individuals. Two hundred T2D patients aged 65–75 years will be randomised 1:1 to supervised exercise training or standard care, stratified by gender, age ≤ or >70 years and non-insulin or insulin treatment. The intervention consists of two weekly supervised sessions, each starting with 5 min of warm-up, followed by 20 min...
Background Psychological well-being and quality of life (QoL) are important outcomes of lifestyle... more Background Psychological well-being and quality of life (QoL) are important outcomes of lifestyle interventions, as a positive impact may favour long-term maintenance of behaviour change. Objective This study investigated the effect of a behavioural intervention for adopting and maintaining an active lifestyle on psychological well-being and health-related QoL in individuals with type 2 diabetes. Methods Three hundred physically inactive and sedentary patients were randomized 1:1 to receive 1 month’s theoretical and practical counselling once a year (intervention group, INT) or standard care (control group, CON) for 3 years. Psychological well-being and QoL, assessed using the World Health Organization (WHO)-5 and the 36-Item Short Form (SF-36) questionnaire, respectively, were pre-specified secondary endpoints. The primary endpoint was sustained behaviour change, as assessed by accelerometer-based measurement of physical activity (PA) and sedentary time. Results WHO-5 and SF-36 phy...
Objective. Quantitative ultrasound (QUS) provides an estimate of bone mineral density (BMD) and a... more Objective. Quantitative ultrasound (QUS) provides an estimate of bone mineral density (BMD) and also evaluates bone quality, which has been related to increased fracture risk in people with diabetes. This study aimed at assessing the correlates of calcaneal QUS parameters in diabetic subjects encompassing various degrees of micro and macrovascular complications and a wide-range of peripheral nerve function. Methods. Four hundred consecutive diabetic patients were examined by QUS to obtain values of broadband ultrasound attenuation (BUA), the speed of sound (SOS), quantitative ultrasound index (QUI), and BMD. Results. Among surrogate measures of complications, sensory and motor nerve amplitude and heart rate response to cough test and standing correlated with QUS parameters at univariate analysis, together with age, body mass index (BMI), waist circumference, lipid profile, and renal function. Multivariate analysis revealed that BUA, SOS, QUI, and BMD were independently associated wi...
OBJECTIVE Adherence to physical activity (PA) recommendations is hampered by the lack of effectiv... more OBJECTIVE Adherence to physical activity (PA) recommendations is hampered by the lack of effective strategies to promote behavior change. The Italian Diabetes and Exercise Study 2 (IDES_2) is a randomized controlled trial evaluating a novel behavioral intervention strategy for increasing PA and decreasing sedentary time (SED-time) in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS The study randomized 300 physically inactive and sedentary patients with type 2 diabetes 1:1 to receive theoretical and practical counseling once yearly for 3 years (intervention group [INT]) or standard care (control group [CON]). Here, we report the 4-month effects on objectively (accelerometer) measured daily light-intensity PA (LPA), moderate-to-vigorous–intensity PA (MVPA), and SED-time, and cardiovascular risk factors. RESULTS LPA and MVPA both increased, and SED-time decreased in both groups, although changes were significantly more marked in INT participants (approximately twofold for LP...
Musculoskeletal disorders are common in subjects with type 2 diabetes mellitus (T2DM) and may rep... more Musculoskeletal disorders are common in subjects with type 2 diabetes mellitus (T2DM) and may represent a barrier to physical activity (PA). In the Italian Diabetes and Exercise Study, we assessed whether a strategy aimed at minimizing the risk of injury and worsening of musculoskeletal symptoms favors participation in exercise training and results in improvements in joint-specific functional scores, along with amelioration of metabolic profile. Sedentary patients with T2DM (n = 606) from 22 outpatient diabetes clinics were randomized to twice-a-week supervised aerobic and resistance training plus exercise counseling (EXE) versus counseling alone (CON) for 12 months. Musculoskeletal symptoms were evaluated at baseline in the entire cohort by the use of a self-reported questionnaire in order to design tailored exercise programs with exclusion of painful segments, and validated joint-specific scores were calculated at the end of study in a subgroup of CON (n = 65) and EXE subjects (n = 62). Musculoskeletal symptoms were present in more than ¾ of EXE and CON subjects. Yet, volumes of non-supervised PA were high, whereas dropout rates and adverse events were low in both groups. Moreover, in the EXE group, no difference was observed between patients with and without symptoms in session attendance and PA/exercise volume. Scores for symptoms and functional status of limbs and spine were significantly better in EXE than in CON subjects and correlated with PA/exercise volume and improvements in fitness parameters. Preliminary evaluation of musculoskeletal symptoms is useful in favoring compliance with supervised training programs and obtaining significant benefits to the functional status of the involved joints.
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