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Teenagers: Impact of Eccentric eXercise Training on Overweight and Obesity (TEXTOO)

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cycling exercises
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Adolescents (12 to 17 Years Old) focused on measuring pediatric obesity, eccentric exercise, body composition, training program

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Concentric cycling exercise (CON)

eccentric cycling exercise (EXC)

Arm Description

40 obese adolescents will be randomized into 2 groups: CON or EXC

40 obese adolescents will be randomized into 2 groups: CON or EXC

Outcomes

Primary Outcome Measures

change in total body fat mass (Dual X ray Absorptiometry)

Secondary Outcome Measures

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

Full Information

First Posted
September 26, 2016
Last Updated
March 6, 2017
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
ONAPS : Observatoire National de l'Activité Physique et de la Sédentarité
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1. Study Identification

Unique Protocol Identification Number
NCT02925572
Brief Title
Teenagers: Impact of Eccentric eXercise Training on Overweight and Obesity
Acronym
TEXTOO
Official Title
Impact of Muscular Training Program on Body Composition of Overweight and Obese Teenagers: classi201c Cycling Exercise in Concentric Versus Eccentric
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
ONAPS : Observatoire National de l'Activité Physique et de la Sédentarité

4. Oversight

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescents (12 to 17 Years Old), Obese (BMI>90th Percentile)
Keywords
pediatric obesity, eccentric exercise, body composition, training program

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concentric cycling exercise (CON)
Arm Type
Experimental
Arm Description
40 obese adolescents will be randomized into 2 groups: CON or EXC
Arm Title
eccentric cycling exercise (EXC)
Arm Type
Experimental
Arm Description
40 obese adolescents will be randomized into 2 groups: CON or EXC
Intervention Type
Other
Intervention Name(s)
Cycling exercises
Intervention Description
All measurements are performed before and after the training program (12 weeks)
Primary Outcome Measure Information:
Title
change in total body fat mass (Dual X ray Absorptiometry)
Time Frame
before and after the 12 weeks training program
Secondary Outcome Measure Information:
Title
aerobic capacities (VO2max)
Time Frame
before and after the 12 weeks training program
Title
isometric muscular lower limbs strength
Time Frame
before and after the 12 weeks training program
Title
isokinetic muscular lower limbs strength
Time Frame
before and after the 12 weeks training program
Title
rest energy expenditure (indirect calorimetry)
Time Frame
before and after the 12 weeks training program
Title
biological parameters (plasma lipid profile and insulin-resistance )
Time Frame
before and after the 12 weeks training program
Title
physical activity (actimetry and questionnaires)
Time Frame
before and after the 12 weeks training program
Title
food intakes (measurements and questionnaires)
Time Frame
before and after the 12 weeks training program
Title
quality of life (questionnaires)
Time Frame
before and after the 12 weeks training program
Title
segmental body composition (segmental fat and fat free mass, Dual X-ray Absorptiometry)
Time Frame
before and after the 12 weeks training program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie JULIAN
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Valérie JULIAN

12. IPD Sharing Statement

Citations:
PubMed Identifier
33121896
Citation
Julian V, Thivel D, Miguet M, Brengues C, Pereira B, Courteix D, Richard R, Duclos M. Bone response to eccentric versus concentric cycling in adolescents with obesity. Obes Res Clin Pract. 2020 Nov-Dec;14(6):554-560. doi: 10.1016/j.orcp.2020.10.002. Epub 2020 Oct 26.
Results Reference
derived

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Teenagers: Impact of Eccentric eXercise Training on Overweight and Obesity

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