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Clinical Trials/NCT01264809
NCT01264809
Unknown
Not Applicable

Does Exercise Consultation Have a Realistic Chance of Increasing the Physical Activity Level of Type 2 Diabetes Patients in Real Life?

University Hospital Center of Martinique2 sites in 1 country80 target enrollmentMarch 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
University Hospital Center of Martinique
Enrollment
80
Locations
2
Primary Endpoint
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.
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
March 2013
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital Center of Martinique

Eligibility Criteria

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

  • 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Benefits obtained after the physical activity counseling(6 months)

Study Sites (2)

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