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?
2 other identifiers
interventional
80
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Mar 2011
Typical duration for not_applicable diabetes-mellitus-type-2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2010
CompletedFirst Posted
Study publicly available on registry
December 22, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedDecember 22, 2010
December 1, 2010
2 years
December 20, 2010
December 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Benefits obtained after the physical activity counseling
6 months
Study Arms (2)
A : immediate physical activity counseling
EXPERIMENTALParticipants 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
ACTIVE COMPARATORExercise 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.
Interventions
Specific consultation
Specific consultation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Center of Martiniquelead
- Clinique Antilles-Guyanecollaborator
Study Sites (2)
CHU de Fort-de-France- Hôpital Pierre Zobda Quitman
Fort-de-France, Martinique, 97261, France
CHU de Bordeaux - Hôpital Haut Lévêque
Pessac, 33604, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cédric FAGOUR, MD
CHU de Fort-de-France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 20, 2010
First Posted
December 22, 2010
Study Start
March 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
December 22, 2010
Record last verified: 2010-12