CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
supervised exercise trainingother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02421393
NCT02421393N/ACompleted

Study to Weigh the Effect of Exercise Training on BONE Quality and Strength (SWEET-BONE) in Type 2 Diabetes: an Exercise Intervention Program for Reducing the Risk of Fractures

Metabolic Fitness Association, Italy·interventional·Posted Apr 20, 2015·Updated Mar 22, 2024

In Brief

A clinical study evaluating supervised exercise training for Type 2 Diabetes. Completed, enrolled 200 participants across 1 site.

Detailed Summary

Type 2 diabetes mellitus (T2DM) is associated with increased fracture risk despite normal to increased bone mass, thus suggesting poor bone quality. This study is aimed at weighing the effect of an exercise intervention program on parameters of bone quality in patients with type 2 diabetes mellitus. Two hundred patients with T2DM will be randomized to supervised exercise training on top of standard care (exercise, EXE, group; n=100) versus standard care (control, CON, group; n=100) for 24 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesItaly

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 20, 2015
Enrollment StartOct 1, 2018
Primary CompletionNov 1, 2023
Study CompletionMar 1, 2024
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 11.2 years ago

Interventions

supervised exercise trainingother

Two weekly sessions of 75 min each, supervised by an exercise specialist in a dedicated gym facility. Each session will include: 5 min of warm up; 20 min of aerobic training using treadmill; 15 min of resistance training of muscle groups of skeletal sites of fragility fractures; 15 min of "weight bearing" exercises using weighted vests; 8 min of core stability training; 8 min of balance training; and 4 min of flexibility training. Weighted vest worn also during aerobic training and any occupational, home and leisure-time physical activity.