- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01289587
Promoting Physical Activity in Patients With Type 2 Diabetes (DIAfit) (DIAfit)
March 23, 2020 updated by: Jardena Puder, University of Lausanne Hospitals
Efficacy and Feasibility of a Program to Promote Physical Activity in Patients With Type 2 Diabetes (DIAfit)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is
- 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
- 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 Type
Interventional
Enrollment (Actual)
185
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lausanne, Switzerland, 1011
- University of Lausanne Hospitals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alternative frequency variant
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)
|
36 sessions of physical activity offered at different frequencies
|
Active Comparator: Standard frequency program
Standard usual program (3 times per week over a period of 12 weeks)
|
36 sessions of physical activity offered at different frequencies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aerobic fitness
Time Frame: End of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
|
Change in aerobic fitness
|
End of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body composition
Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
|
Change in body composition
|
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)
|
Change in BMI
|
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)
|
Change in HbA1c
|
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)
|
Change in Lipid values
|
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)
|
Change in motor performance
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At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
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Physical activity
Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
|
Change in physical activity
|
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)
|
Change in well-being (validated questionnaire)
|
At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
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Self-efficacy
Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
|
Change in self-efficacy (questionnaire)
|
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)
|
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
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During the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
January 28, 2011
First Submitted That Met QC Criteria
February 3, 2011
First Posted (Estimate)
February 4, 2011
Study Record Updates
Last Update Posted (Actual)
March 24, 2020
Last Update Submitted That Met QC Criteria
March 23, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 252/10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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