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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02938117
Other study ID # CHU-0284
Secondary ID 2016-A01185-46
Status Not yet recruiting
Phase N/A
First received October 10, 2016
Last updated October 17, 2016
Start date January 2017
Est. completion date January 2020

Study information

Verified date October 2016
Source University Hospital, Clermont-Ferrand
Contact Patrick LACARIN
Phone 04 73 75 11 95
Email placarin@chu-clermontferrand.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

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


Description:

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. The training program will last 12 weeks for the two groups. Before and after, each subjects will participate to the following measurements: total and segmental body composition (DXA), aerobic capacities (maximal incremental exercise test, VO2max), muscular lower limbs strength (isometric end isokinetic dynamometer), rest energy expenditure (indirect calorimetry), biological parameters (lipid profile, insulin-resistance), physical activity (actimetry), food intakes and quality of life (questionnaires).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date January 2020
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 35 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)


Related Conditions & MeSH terms


Intervention

Other:
cycling exercises


Locations

Country Name City State
France CHU Clermont-Ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in total body fat mass (Dual X ray Absorptiometry) before and after the 12 weeks training program Yes
Secondary aerobic capacities (VO2max) before and after the 12 weeks training program Yes
Secondary isometric muscular lower limbs strength before and after the 12 weeks training program Yes
Secondary isokinetic muscular lower limbs strength before and after the 12 weeks training program Yes
Secondary rest energy expenditure (indirect calorimetry) before and after the 12 weeks training program Yes
Secondary biological parameters (plasma lipid profile) before and after the 12 weeks training program Yes
Secondary biological parameters (insulin-resistance) before and after the 12 weeks training program Yes
Secondary physical activity (questionnaires) before and after the 12 weeks training program Yes
Secondary physical activity (actimetry) before and after the 12 weeks training program Yes
Secondary food intakes (measurements) before and after the 12 weeks training program Yes
Secondary food intakes (questionnaires) before and after the 12 weeks training program Yes
Secondary quality of life (questionnaires) before and after the 12 weeks training program Yes
Secondary segmental body composition (segmental fat and fat free mass) before and after the 12 weeks training program Yes
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