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

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ClinicalTrials.gov Identifier: NCT00234273
Recruitment Status : Terminated (recrutment)
First Posted : October 6, 2005
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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.

Condition or disease Intervention/treatment Phase
NIDDM Procedure: Rehabilitation programme in Adapted Physical Activity (APA) Behavioral: Therapeutic education primarily focused on dietary Phase 2

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Effects Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics Persons
Study Start Date : November 2004
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Therapeutic education combining dietary and rehabilitation
Therapeutic education combining dietary and rehabilitation (APA)
Procedure: Rehabilitation programme in Adapted Physical Activity (APA)
Behavioral: Therapeutic education primarily focused on dietary
Active Comparator: Therapeutic education primarily focused on dietary
Therapeutic education primarily focused on dietary
Behavioral: Therapeutic education primarily focused on dietary



Primary Outcome Measures :
  1. Increase physical activity compliance long-term [ Time Frame: 6 months after the beginning of the program ]
    Modifiable Activity Questionnaire (MAQ

  2. Lessen insulin resistance [ Time Frame: 6 months after the beginning of the program ]
    HOMA (Homeo-stasis model assessment), HbA1c, PCGL


Secondary Outcome Measures :
  1. Improve the quality of life [ Time Frame: 6 months after the beginning of the program ]
    Short Form-36 Health Survey Questionnary (SF-36)

  2. Improve the arterial tension [ Time Frame: 6 months after the beginning of the program ]
    arterial tension

  3. Lessen the weight [ Time Frame: 6 months after the beginning of the program ]
    weight



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234273


Locations
France
Endocrinology, Diabetology and Nutrition - University Hospital of Grenoble
Grenoble, Rhone-alpes, France, 38000
Department of Endocrinology, Diabetology and Nutrition
Grenoble, Rhône-Alpes, France, 38000
Endocrinology, Diabetology and Nutrition Department - University Hospital of Grenoble
Grenoble, France, 38000
HALIMI Serge
Grenoble, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: HALIMI Serge Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Halimi S. Therapeutic strategies for type 2 diabetes. Rev Prat HALIMI Institut National de la Santé Et de la Recherche Médicale, France