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

This study has been terminated.
(recrutment)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00234273
First received: October 5, 2005
Last updated: June 18, 2013
Last verified: June 2013

October 5, 2005
June 18, 2013
November 2004
June 2008   (final data collection date for primary outcome measure)
  • Increase physical activity compliance long-term [ Time Frame: 6 months after the beginning of the program ] [ Designated as safety issue: No ]
    Modifiable Activity Questionnaire (MAQ
  • Lessen insulin resistance [ Time Frame: 6 months after the beginning of the program ] [ Designated as safety issue: No ]
    HOMA (Homeo-stasis model assessment), HbA1c, PCGL
  • Increase physical activity compliance long-term
  • Lessen resitance insulin
Complete list of historical versions of study NCT00234273 on ClinicalTrials.gov Archive Site
  • Improve the quality of life [ Time Frame: 6 months after the beginning of the program ] [ Designated as safety issue: No ]
    Short Form-36 Health Survey Questionnary (SF-36)
  • Improve the arterial tension [ Time Frame: 6 months after the beginning of the program ] [ Designated as safety issue: No ]
    arterial tension
  • Lessen the weight [ Time Frame: 6 months after the beginning of the program ] [ Designated as safety issue: No ]
    weight
  • Improve the quality of life
  • Improve the arterial tension
  • Lessen the weight
  • Improve body composition
  • Lessen abdominal perimeter
  • Lessen treatment dosage
  • Lessen the number of hospitalisation thick diabetes complications acutes
Not Provided
Not Provided
 
APAD2: Effects of Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics
Effects Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics Persons

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
NIDDM
  • Procedure: Rehabilitation programme in Adapted Physical Activity (APA)
  • Behavioral: Therapeutic education primarily focused on dietary
  • Experimental: Therapeutic education combining dietary and rehabilitation
    Therapeutic education combining dietary and rehabilitation (APA)
    Interventions:
    • 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
    Intervention: Behavioral: Therapeutic education primarily focused on dietary

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
40 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00234273
DCIC 03 09
No
University Hospital, Grenoble
University Hospital, Grenoble
Not Provided
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
University Hospital, Grenoble
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP