- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02938117
Impact of a Training Program on the Body Composition of Overweight and Obese Young Adults : Concentric Versus Eccentric Exercise (OPEX)
Nowadays, eccentric exercise can be realized in a dynamic way with an ergocycle wich permits eccentric (ECC) lower limbs contractions at a defined power output. With this type of ergometer, O2 consumption (VO2) in ECC is three fold lower than in concentric (CON) for the same power output. Consequently, ECC program could be used in chronic disorders with limited capacities, such as obesity.
The investigators hypothesis that an eccentric training program, as it will induce higher mechanical constraints, would improve body composition, especially by reducing fat mass. This effect could be explained by an increased rest energy expenditure and a better improvement in biological parameters (particularly lipid profile and insulin-resistance) after ECC training (versus CON training).
This study aims to compare the modification of fat mass after an ECC program versus a CON program at the same VO2. The secondary goal is to assess the physiological mechanisms involved in the modification of body composition
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Clermont-Ferrand, France, 63003
- CHU Clermont-Ferrand
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- - Adults
- Obese (BMI>35)
- Inactive (<10 METS/h/week)
- No other chronic disease (cardio pulmonary, osteo articulary or muscular diseases), no surgery during the last 3 months, no contraindication to physical activity
Exclusion Criteria:
- (BMI<35)
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CON : concentric cycling exercise
Thirty adults will be randomized into 2 groups: CON or EXC.
The patients of ECC group will follow habituation sessions (2weeks) to avoid the secondary muscular effects of high intensity eccentric exercise
|
|
Experimental: EXC : eccentric cycling exercise
Thirty adults will be randomized into 2 groups: CON or EXC.
The patients of ECC group will follow habituation sessions (2weeks) to avoid the secondary muscular effects of high intensity eccentric exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in total body fat mass (Dual X ray Absorptiometry)
Time Frame: before and after the 12 weeks training program
|
before and after the 12 weeks training program
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
aerobic capacities (VO2max)
Time Frame: before and after the 12 weeks training program
|
before and after the 12 weeks training program
|
|
isometric muscular lower limbs strength
Time Frame: before and after the 12 weeks training program
|
before and after the 12 weeks training program
|
|
isokinetic muscular lower limbs strength
Time Frame: before and after the 12 weeks training program
|
before and after the 12 weeks training program
|
|
rest energy expenditure (indirect calorimetry)
Time Frame: before and after the 12 weeks training program
|
before and after the 12 weeks training program
|
|
biological parameters (plasma lipid profile)
Time Frame: before and after the 12 weeks training program
|
before and after the 12 weeks training program
|
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biological parameters (insulin-resistance)
Time Frame: before and after the 12 weeks training program
|
before and after the 12 weeks training program
|
|
physical activity
Time Frame: before and after the 12 weeks training program
|
(questionnaires)
|
before and after the 12 weeks training program
|
physical activity
Time Frame: before and after the 12 weeks training program
|
(actimetry)
|
before and after the 12 weeks training program
|
food intakes
Time Frame: before and after the 12 weeks training program
|
(measurements)
|
before and after the 12 weeks training program
|
food intakes
Time Frame: before and after the 12 weeks training program
|
(questionnaires)
|
before and after the 12 weeks training program
|
quality of life (questionnaires)
Time Frame: before and after the 12 weeks training program
|
before and after the 12 weeks training program
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segmental body composition
Time Frame: before and after the 12 weeks training program
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(segmental fat and fat free mass)
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before and after the 12 weeks training program
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Collaborators and Investigators
Investigators
- Principal Investigator: Valérie JULIAN, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-0284
- 2016-A01185-46 (Other Identifier: 2016-A01185-46)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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