Teenagers: Impact of Eccentric eXercise Training on Overweight and Obesity

Adolescents (12 to 17 Years Old) Clinical Trial

— TEXTOO  

Official title:

Impact of Muscular Training Program on Body Composition of Overweight and Obese Teenagers: classi201c Cycling Exercise in Concentric Versus Eccentric

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02925572
• Other study ID #: CHU-0279
• Secondary ID: 2016-A00043-48
• Status: Recruiting
• Phase: N/A
• First received: September 26, 2016
• Last updated: March 6, 2017
• Start date: January 1, 2017
• Est. completion date: January 2020

Study information

• Verified date: March 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Nowadays, eccentric exercise can be realized in a dynamic way with an ergocycle which 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:

40 obese adolescents will be randomized into 2 groups: CON or EXC. The patients of ECC group will follow habituation sessions (2 weeks) 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 and 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: Recruiting
• Enrollment: 40
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• Adolescent (12 to 17 years old)

• BMI>90th percentile

• Post puberty (Tanner 3 to 5)

• Inactive (<10 METS/h/week)

• No other chronic disease (cardio pulmonary, osteo articulary or muscular diseases), no surgery during the last 3 months, no genetic obesity and no contraindication to physical activity

Exclusion Criteria:

Related Conditions & MeSH terms

• Adolescents (12 to 17 Years Old)
• Obese (BMI>90th Percentile)
• Overweight

Intervention

Other:
• Cycling exercises
All measurements are performed before and after the training program (12 weeks)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	ONAPS : Observatoire National de l’Activité Physique et de la Sédentarité

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