Exercise Consultation for Type 2 Diabetes Patients in Real Life (APDT 2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Centre Hospitalier Universitaire de Fort-de-France.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Clinique Antilles-Guyane
Information provided by:
Centre Hospitalier Universitaire de Fort-de-France
ClinicalTrials.gov Identifier:
NCT01264809
First received: December 20, 2010
Last updated: December 21, 2010
Last verified: December 2010

December 20, 2010
December 21, 2010
March 2011
March 2013   (final data collection date for primary outcome measure)
Change in daily physical activity measured by SenseWear Pro3 Armband®. Participants were instructed to wear the monitor for seven days during all waking hours except bathing. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01264809 on ClinicalTrials.gov Archive Site
Benefits obtained after the physical activity counseling [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

The secondary outcome of this study is to compare the benefits obtained 3 and 6 mounths after the physical activity counseling on :

  • Quality of life scores
  • Anthropometric measurement and Body Mass Index (BMI)
  • Body composition measurement
  • Hand grip strength
  • Blood pressure
  • Glycaemic control and cholesterol
  • Medication
Same as current
Not Provided
Not Provided
 
Exercise Consultation for Type 2 Diabetes Patients in Real Life
Does Exercise Consultation Have a Realistic Chance of Increasing the Physical Activity Level of Type 2 Diabetes Patients in Real Life?

The prevalence of type 2 diabetes is high and expected to increase dramatically in worldwide, in France and especially in the French West Indies.This chronic disease is associated with premature mortality and various debilitating complications which can be prevented by optimal control of glycaemia, blood pressure and lipids. Diabetes management includes lifestyle modification and medication. Despite numerous studies supporting the benefits of frequent physical activity for people with Type 2 diabetes, an estimated 60±80% of this population remain sedentary. Promotion of physical activity in current diabetes care seems to be inadequate.

The aim of this randomized controlled trial is to evaluate the medium-term effectiveness (after 3 and 6months) of exercise consultation in promoting physical activity in outpatients with Type 2 diabetes.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Diabetes Mellitus, Type 2
  • Behavioral: Specific consultation for physical activity counseling
    Specific consultation
  • Behavioral: Consultation for physical activity counseling
    Specific consultation
  • Experimental: A : immediate physical activity counseling
    Participants randomized in the experimental group (group A) will receive physical activity counseling during a one-to-one consultation at both baseline and 3 months.
    Intervention: Behavioral: Specific consultation for physical activity counseling
  • Active Comparator: B : later physical activity counseling
    Exercise consultation will be realised only at 3 months in the control group(group B). Furthermore, patients of group B will not received any physical activity counseling at baseline.
    Intervention: Behavioral: Consultation for physical activity counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
80
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 DM diagnosed within 10 years prior the inclusion
  • 18-70 years old
  • Signed written informed consent
  • Diabetes treatment regimens :

    • diet only
    • oral antidiabetic drug
    • oral antidiabetic drugs with long acting insulin analog
    • oral antidiabetic drugs with GLP 1 analog

Exclusion Criteria:

  • Minors
  • Patients with concurrent medical conditions preventing exercise
  • Pregnancy or intention to become pregnant during the study
  • Inability to read and write French
  • History of participating in our education program during the past two years
  • Usual sporty activities
  • Change in diabetes treatment during the three months prior to study enrollment
  • No written informed consent
Both
18 Years to 70 Years
No
Contact: Jocelyne CRASPAG (0)596592698 ext +596 jocelyne.craspag@chu-fortdefrance.fr
Contact: Mickaëlle ROSE (0) 596592698 ext +596 mickaelle.rose@chu-fortdefrance.fr
France
 
NCT01264809
09/B/07, 2010-A00450-39
Yes
FAGOUR Cédric, CHU de Fort-de-France
Centre Hospitalier Universitaire de Fort-de-France
Clinique Antilles-Guyane
Principal Investigator: Cédric FAGOUR, MD CHU de Fort-de-France
Centre Hospitalier Universitaire de Fort-de-France
December 2010

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