Effects Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics Persons
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- NIDDM
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 10
- Locations
- 4
- Primary Endpoint
- Increase physical activity compliance long-term
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
Brief Summary
The principal objective is to assess and analyze the effects of a six month programme in Adapted Physical Activity (APA) on physical activity, compliance, and insulin resistance among type 2 diabetics.
Detailed Description
Clinical trial with direct individual profit. Study phase 2. Study center: University Hospital Grenoble Principal investigator: Pr. Serge HALIMI Sponsor: University Hospital Grenoble The principal objective is to assess and analyze the effects of a six month programme in Adapted Physical Activity (APA) on physical activity, compliance, and insulin resistance among type 2 diabetics. Secondary objectives are to assess and analyze the effects of a six month programme in APA of: * arterial tension * weight, body composition and abdominal perimeter * quality of life * treatment dosage * number of hospitalisation thick a diabetes complication acute for one year and for each patient Compare two exercise's intensity: first lactate threshold (SL1) and crossover (PCGL). Inclusion criteria: * type 2 diabetics * age \> 40 years * first education in Education Diabetics Department of University Hospital Grenoble * sedentary patients * HbA1c \> 7%- * BMI \> 25 * to be affiliate disease assurance * to give consent written and inform Judgment criteria for physical activity compliance: * leisure time physical activity: Modifiable Activity Questionnaire * training note-book Judgment criteria for resistance insulin: * Crossover (PCGL) * HOMA and FIRI index * HbA1c Programme test: Rehabilitation programme in Adapted Physical Activity (APA) Programme test period: 6 months Study total period: 28 months Study period for each patient: 18 months Safety criteria: clinical compendium undesirable events
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 2 diabetics
- •Age \> 40
- •First education in the Education Diabetics Department of the University Hospital Grenoble
- •Sedentary patients
- •Hemoglobin A1c (HbA1c) \> 7%
- •Body mass index (BMI) \> 25
- •To be affiliated with disease assurance
- •To give written and informed consent
Exclusion Criteria
- •Foot sore \< six months
- •Renal disease - proteinuria stage
- •Contraindication for exercise
- •VO2 max \> 120% Wassermann standard
- •Coronary pathology non-stabilization
- •Arteriopathy stage 2 non-compensation
- •Osteo-articular crippling problem
- •Geographically distant
Outcomes
Primary Outcomes
Increase physical activity compliance long-term
Time Frame: 6 months after the beginning of the program
Modifiable Activity Questionnaire (MAQ
Lessen insulin resistance
Time Frame: 6 months after the beginning of the program
HOMA (Homeo-stasis model assessment), HbA1c, PCGL
Secondary Outcomes
- Improve the arterial tension(6 months after the beginning of the program)
- Lessen the weight(6 months after the beginning of the program)
- Improve the quality of life(6 months after the beginning of the program)