Overview

This trial is active, not recruiting.

Condition diabetes
Treatment physical activity intervention
Sponsor University of Lausanne Hospitals
Collaborator University Hospital, Geneva
Start date February 2011
End date December 2012
Trial size 120 participants
Trial identifier NCT01289587, 252/10

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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)
physical activity intervention
36 sessions of physical activity offered at different frequencies
(Active Comparator)
Standard usual program (3 times per week over a period of 12 weeks)
physical activity intervention
36 sessions of physical activity offered at different frequencies

Primary Outcomes

Measure
Aerobic fitness
time frame: End of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)

Secondary Outcomes

Measure
Body composition
time frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
BMI
time frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
HbA1c
time frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Lipid values
time frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Motor performance
time frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Physical activity
time frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Well-being
time frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Self-efficacy
time frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Qualitative evaluation (satisfaction of achievement of personal objectives, evaluation of group session)
time frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Adherence/Attendance: Number of physical activity sessions attended
time frame: During the intervention

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Efficacy and Feasibility of a Program to Promote Physical Activity in Patients With Type 2 Diabetes (DIAfit)
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)
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Lausanne Hospitals.