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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Specific consultation for physical activity counseling; Behavioral: Consultation for physical activity counseling

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pessac, France, 33604
    • CHU de Bordeaux - Hôpital Haut Leveque
  • Martinique
    • Fort-de-France, Martinique, France, 97261
      • CHU de Fort-de-France- Hôpital Pierre Zobda Quitman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Specific consultation for physical activity counseling; Specific consultation
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.	Behavioral: Consultation for physical activity counseling; Specific consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Benefits obtained after the physical activity counseling	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	6 months

Collaborators and Investigators

• Sponsor: University Hospital Center of Martinique
• Collaborators: Clinique Antilles-Guyane
• Investigators: Principal Investigator: Cédric FAGOUR, MD, CHU de Fort-de-France

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: December 20, 2010
• First Submitted That Met QC Criteria: December 21, 2010
• First Posted (Estimate): December 22, 2010

Study Record Updates

• Last Update Posted (Estimate): December 22, 2010
• Last Update Submitted That Met QC Criteria: December 21, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 09/B/07; 2010-A00450-39 (Other Identifier: Afssaps- French Health Products Safety Agency)