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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University Hospital, Geneva
Information provided by (Responsible Party):
Jardena Puder, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01289587
First received: January 28, 2011
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Diabetes
Behavioral: Physical activity intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Feasibility of a Program to Promote Physical Activity in Patients With Type 2 Diabetes (DIAfit)

Resource links provided by NLM:


Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • Aerobic fitness [ Time Frame: End of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) ] [ Designated as safety issue: No ]
    Change in aerobic fitness


Secondary Outcome Measures:
  • Body composition [ Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) ] [ Designated as safety issue: No ]
    Change in body composition

  • BMI [ Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) ] [ Designated as safety issue: No ]
    Change in BMI

  • HbA1c [ Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) ] [ Designated as safety issue: No ]
    Change in HbA1c

  • Lipid values [ Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) ] [ Designated as safety issue: No ]
    Change in Lipid values

  • Motor performance [ Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) ] [ Designated as safety issue: No ]
    Change in motor performance

  • Physical activity [ Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) ] [ Designated as safety issue: No ]
    Change in physical activity

  • Well-being [ Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) ] [ Designated as safety issue: No ]
    Change in well-being (validated questionnaire)

  • Self-efficacy [ Time Frame: At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment) ] [ Designated as safety issue: No ]
    Change in self-efficacy (questionnaire)

  • 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) ] [ Designated as safety issue: No ]
  • Adherence/Attendance: Number of physical activity sessions attended [ Time Frame: During the intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2011
Estimated Study Completion Date: October 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Behavioral: Physical activity intervention
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)
Behavioral: Physical activity intervention
36 sessions of physical activity offered at different frequencies

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289587

Locations
Switzerland
University of Lausanne Hospitals
Lausanne, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
University Hospital, Geneva
  More Information

Additional Information:
No publications provided

Responsible Party: Jardena Puder, MD, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01289587     History of Changes
Other Study ID Numbers: 252/10
Study First Received: January 28, 2011
Last Updated: April 18, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Lausanne Hospitals:
Diabetes
Physical activity
Body composition
Aerobic fitness
Metabolic control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014