Promoting Physical Activity in Patients With Type 2 Diabetes (DIAfit)

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Behavioral: Physical activity intervention

• Registration Number: NCT01289587
• Lead Sponsor: University of Lausanne Hospitals

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)

Study Timeline

• Study First Submitted: 2011-01-28
• Study Start: 2011-02
• Study First Submitted QC: 2011-02-03
• Study First Posted: 2011-02-04
• Primary Completion: 2012-12
• Study Completion: 2017-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alternative frequency variant	Physical activity intervention	An alternative variant of the DIAfit program (progressive increase of the number of administered PA sessions per week, namely one PA session per week during 4 weeks and then twice a week over a period of 16 weeks)
Standard frequency program	Physical activity intervention	Standard usual program (3 times per week over a period of 12 weeks)

Primary Outcome Measures

Name	Time	Method
Aerobic fitness	End of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)	Change in aerobic fitness

Secondary Outcome Measures

Name	Time	Method
Body composition	At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)	Change in body composition
Lipid values	At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)	Change in Lipid values
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
Self-efficacy	At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)	Change in self-efficacy (questionnaire)
HbA1c	At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)	Change in HbA1c
Physical activity	At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)	Change in physical activity
Motor performance	At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)	Change in motor performance
BMI	At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)	Change in BMI
Well-being	At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)	Change in well-being (validated questionnaire)

Trial Locations

Locations (1)

University of Lausanne Hospitals; 🇨🇭 Lausanne, Switzerland