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
Recruitment status was Not yet recruiting
Sponsor:
Centre Hospitalier Universitaire de Fort-de-France
Collaborator:
Centre d'Investigation Clinique - Epidémiologie Clinique CIE 802
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus, Type 2 |
Behavioral: Specific consultation for physical activity counseling Behavioral: Consultation for physical activity counseling |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Does Exercise Consultation Have a Realistic Chance of Increasing the Physical Activity Level of Type 2 Diabetes Patients in Real Life? |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire de Fort-de-France:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264809
Contacts
| Contact: Jocelyne CRASPAG | (0)596592698 ext +596 | jocelyne.craspag@chu-fortdefrance.fr |
| Contact: Mickaëlle ROSE | (0) 596592698 ext +596 | mickaelle.rose@chu-fortdefrance.fr |
Locations
| France | |
| CHU de Fort-de-France- Hôpital Pierre Zobda Quitman | Not yet recruiting |
| Fort-de-France, Martinique, France, 97261 | |
| Contact: Cédric FAGOUR, MD (0)596552241 ext +596 cedric.fagour@chu-fortdefrance.fr | |
| Contact: Miguelle ROSETTE-NARECE, MD (0)596552241 ext +596 miguelle.rosette-narece@chu-fortdefrance.fr | |
| Principal Investigator: Cedric FAGOUR, MD | |
| Sub-Investigator: Miguelle ROSETTE-NARECE, MD | |
| CHU de Bordeaux - Hôpital Haut Lévêque | Not yet recruiting |
| Pessac, France, 33604 | |
| Contact: Vincent RIGALLEAU, MD-PhD (0)556795679 ext +33 vincent.rigalleau@chu-bordeaux.fr | |
| Contact: Henri GIN, MD-PhD (0)556795679 ext +33 henri.gin@chu-bordeaux.fr | |
| Principal Investigator: Vincent RIGALLEAU, MD-PhD | |
| Sub-Investigator: Henri GIN, MD-PhD | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Fort-de-France
Centre d'Investigation Clinique - Epidémiologie Clinique CIE 802
Investigators
| Principal Investigator: | Cédric FAGOUR, MD | CHU de Fort-de-France |
More Information
No publications provided
| Responsible Party: | FAGOUR Cédric, CHU de Fort-de-France |
| ClinicalTrials.gov Identifier: | NCT01264809 History of Changes |
| Other Study ID Numbers: | 09/B/07, 2010-A00450-39 |
| Study First Received: | December 20, 2010 |
| Last Updated: | December 21, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Hospitalier Universitaire de Fort-de-France:
|
diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013