APAD2: Effects of Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics

Study Overview
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Brief Summary
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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
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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

Official Title
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Effects Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics Persons

Conditions
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NIDDM

Intervention / Treatment
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* Procedure: Rehabilitation programme in Adapted Physical Activity (APA)
* Behavioral: Therapeutic education primarily focused on dietary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic education combining dietary and rehabilitation<br>Therapeutic education combining dietary and rehabilitation (APA) | Procedure: Rehabilitation programme in Adapted Physical Activity (APA)<br> <br> Behavioral: Therapeutic education primarily focused on dietary<br> <br> |
| Active Comparator: Therapeutic education primarily focused on dietary<br>Therapeutic education primarily focused on dietary | Behavioral: Therapeutic education primarily focused on dietary<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase physical activity compliance long-term | Modifiable Activity Questionnaire (MAQ | 6 months after the beginning of the program | 
| Lessen insulin resistance | HOMA (Homeo-stasis model assessment), HbA1c, PCGL | 6 months after the beginning of the program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve the quality of life | Short Form-36 Health Survey Questionnary (SF-36) | 6 months after the beginning of the program | 
| Improve the arterial tension | arterial tension | 6 months after the beginning of the program | 
| Lessen the weight | weight | 6 months after the beginning of the program | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adapted Physical Activity, Quality of life, cardiovascular risk, teaching, Directly Observed Therapy, Physical activity