Exercise Consultation for Type 2 Diabetes Patients in Real Life

Not Applicable

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Specific consultation for physical activity counseling; Behavioral: Consultation for physical activity counseling

• Registration Number: NCT01264809
• Lead Sponsor: University Hospital Center of Martinique

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-12
• Study First Submitted: 2010-12-20
• Study First Submitted QC: 2010-12-21
• Last Update Submitted: 2010-12-21
• Study First Posted: 2010-12-22
• Last Update Posted: 2010-12-22
• Study Start: 2011-03
• Primary Completion: 2013-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A : immediate physical activity counseling	Specific consultation for 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.
B : later physical activity counseling	Consultation for 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Benefits obtained after the physical activity counseling	6 months	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

Trial Locations

Locations (2)

CHU de Bordeaux - Hôpital Haut Lévêque; 🇫🇷 Pessac, France

CHU de Fort-de-France- Hôpital Pierre Zobda Quitman; 🇫🇷 Fort-de-France, Martinique, France