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

Diabetes Clinical Trial

— DIAfit  

Official title:

Efficacy and Feasibility of a Program to Promote Physical Activity in Patients With Type 2 Diabetes (DIAfit)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289587
• Other study ID #: 252/10
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: October 2017

Study information

• Verified date: March 2020
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: October 2017
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Behavioral:
• Physical activity intervention
36 sessions of physical activity offered at different frequencies

Locations

Country	Name	City	State
Switzerland	University of Lausanne Hospitals	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
University of Lausanne Hospitals	University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aerobic fitness	Change in aerobic fitness	End of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Secondary	Body composition	Change in body composition	At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Secondary	BMI	Change in BMI	At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Secondary	HbA1c	Change in HbA1c	At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Secondary	Lipid values	Change in Lipid values	At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Secondary	Motor performance	Change in motor performance	At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Secondary	Physical activity	Change in physical activity	At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Secondary	Well-being	Change in well-being (validated questionnaire)	At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Secondary	Self-efficacy	Change in self-efficacy (questionnaire)	At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Secondary	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)
Secondary	Adherence/Attendance: Number of physical activity sessions attended		During the intervention

External Links

•   Website of the program