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Completed

NCT Number: NCT01289587

Promoting 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.

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Key information

Conditions

Diabetes Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Lausanne Hospitals

Lausanne, 1011, Switzerland

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

physical activity intervention

Behavioral

36 sessions of physical activity offered at different frequencies

Primary outcomes

  1. Aerobic fitness

    Time frame: End of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)

    Change in aerobic fitness

Secondary outcomes

  1. Body composition

    Time frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)

    Change in body composition

  2. BMI

    Time frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)

    Change in BMI

  3. HbA1c

    Time frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)

    Change in HbA1c

  4. Lipid values

    Time frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)

    Change in Lipid values

  5. Motor performance

    Time frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)

    Change in motor performance

  6. Physical activity

    Time frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)

    Change in physical activity

  7. 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)

  8. 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)

  9. 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)

  10. Adherence/Attendance: Number of physical activity sessions attended

    Time frame: During the intervention

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Collaborators

  • University Hospital, Geneva

Registry information

Official study title

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

Acronym: DIAfit

Important dates

Study start
2011
Primary completion
2012
Study completion
2017
First posted
Feb 4, 2011
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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