Clinical trial NCT01289587: Promoting Physical Activity in Patients With Type 2 Diabetes (DIAfit)
Official title: Efficacy and Feasibility of a Program to Promote Physical Activity in Patients With Type 2 Diabetes (DIAfit)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Physical activity
Body composition
Aerobic fitness
Metabolic control
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
First posted: 2011-02-04
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Aerobic fitness
timeFrame: End of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Secondary outcomes:
measure: Body composition
timeFrame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
measure: BMI
timeFrame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
measure: HbA1c
timeFrame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
measure: Lipid values
timeFrame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
measure: Motor performance
timeFrame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
measure: Physical activity
timeFrame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
measure: Well-being
timeFrame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
measure: Self-efficacy
timeFrame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
measure: Qualitative evaluation (satisfaction of achievement of personal objectives, evaluation of group session)
timeFrame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
measure: Adherence/Attendance: Number of physical activity sessions attended
timeFrame: During the intervention
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University of Lausanne Hospitals
Study officials:
References:
citation: Allet L, Giet O, Barral J, Junod N, Durrer D, Amati F, Sykiotis GP, Marques-Vidal P, Puder JJ. Educational Level Is Related to Physical Fitness in Patients with Type 2 Diabetes - A Cross-Sectional Study. PLoS One. 2016 Oct 12;11(10):e0164176. doi: 10.1371/journal.pone.0164176. eCollection 2016.