Diabetes
Conditions
Keywords
Diabetes, Physical activity, Body composition, Aerobic fitness, Metabolic control
Brief summary
The aim of this study is to evaluate the effects of a physical activity intervention in patients with type 2 diabetes in a community setting.
Detailed description
The aim of this study is 1. to evaluate the effects (before and after) of a physical activity program (DIAfit program) which contains 36 sessions of structured PA and also encourages unstructured PA in an unselected population of patients with type 2 diabetes independent of the selected variant of the program 2. to compare the effects of a standard DIAfit program (3 times per week for 12 weeks) with and alternative program which suggests a more progressive PA activity intensity (starting with one PA session per week during 4 weeks and then twice a week over a period of 16 more weeks (20 weeks total). In total the program also consist of 36 sessions)
Interventions
BEHAVIORALPhysical activity intervention
36 sessions of physical activity offered at different frequencies
Sponsors
University Hospital, Geneva
University of Lausanne Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of type 2 diabetes
Exclusion criteria
* Orthopedic complications * Diabetic foot ulceration * Active cardiac (ischemia during the exercise test) or stade III peripheral vascular disease * Untreated proliferative retinopathy * Autonomic neuropathy * Active psychiatric, neurological, orthopedic, muscular or rheumatic disease interfering with a participation in a physical activity program * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aerobic fitness | End of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | Change in aerobic fitness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI | At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | Change in BMI |
| HbA1c | At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | Change in HbA1c |
| Lipid values | At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | Change in Lipid values |
| Motor performance | At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | Change in motor performance |
| Body composition | At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | Change in body composition |
| Well-being | At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | Change in well-being (validated questionnaire) |
| Self-efficacy | At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | Change in self-efficacy (questionnaire) |
| Qualitative evaluation (satisfaction of achievement of personal objectives, evaluation of group session) | At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | — |
| Adherence/Attendance: Number of physical activity sessions attended | During the intervention | — |
| Physical activity | At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) | Change in physical activity |
Countries
Switzerland
Outcome results
None listed