NCT02938117

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

2.9 years

First QC Date

October 10, 2016

Last Update Submit

October 17, 2016

Conditions

AdultsBMI>35

Keywords

obesityeccentric exercisebody compositiontraining program

Outcome Measures

Primary Outcomes (1)

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

    before and after the 12 weeks training program

Secondary Outcomes (12)

  • aerobic capacities (VO2max)

    before and after the 12 weeks training program

  • isometric muscular lower limbs strength

    before and after the 12 weeks training program

  • isokinetic muscular lower limbs strength

    before and after the 12 weeks training program

  • rest energy expenditure (indirect calorimetry)

    before and after the 12 weeks training program

  • biological parameters (plasma lipid profile)

    before and after the 12 weeks training program

  • +7 more secondary outcomes

Study Arms (2)

CON : concentric cycling exercise

EXPERIMENTAL

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

Other: cycling exercises

EXC : eccentric cycling exercise

EXPERIMENTAL

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

Other: cycling exercises

Interventions

cycling exercisesOTHER
CON : concentric cycling exerciseEXC : eccentric cycling exercise

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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

You may not qualify if:

  • (BMI\<35)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Valérie JULIAN

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 19, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

October 19, 2016

Record last verified: 2016-10

Locations

FR(1)