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Clinical Trials/NCT00234273
NCT00234273
Terminated
Phase 2

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

University Hospital, Grenoble4 sites in 1 country10 target enrollmentNovember 2004
ConditionsNIDDM

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

Registry
clinicaltrials.gov
Start Date
November 2004
End Date
June 2008
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

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)

Study Sites (4)

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