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

June 18, 2013 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • Endocrinology, Diabetology and Nutrition Department - University Hospital of Grenoble
      • Grenoble, France, 38000
        • HALIMI Serge
    • Rhone-alpes
      • Grenoble, Rhone-alpes, France, 38000
        • Endocrinology, Diabetology and Nutrition - University Hospital of Grenoble
    • Rhône-Alpes
      • Grenoble, Rhône-Alpes, France, 38000
        • Department of Endocrinology, Diabetology and Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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
Behavioral: Therapeutic education primarily focused on dietary

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase physical activity compliance long-term
Time Frame: 6 months after the beginning of the program
Modifiable Activity Questionnaire (MAQ
6 months after the beginning of the program
Lessen insulin resistance
Time Frame: 6 months after the beginning of the program
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
Time Frame: 6 months after the beginning of the program
Short Form-36 Health Survey Questionnary (SF-36)
6 months after the beginning of the program
Improve the arterial tension
Time Frame: 6 months after the beginning of the program
arterial tension
6 months after the beginning of the program
Lessen the weight
Time Frame: 6 months after the beginning of the program
weight
6 months after the beginning of the program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

October 5, 2005

First Submitted That Met QC Criteria

October 5, 2005

First Posted (ESTIMATE)

October 6, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DCIC 03 09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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