AdultsOPEXNCT02938117
Impact of a Training Program on the Body Composition of Overweight and Obese Young Adults : Concentric Versus Eccentric Exercise
A study testing cycling exercises in people with Adults and BMI>35, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- What is being tested?
- cycling exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - 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
Who cannot join
- (BMI<35)
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Valérie JULIAN
About this study
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
Read the detailed 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).
- Being tested
- cycling exercises
- Keywords
- obesity, eccentric exercise, body composition, training program
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cycling exercisesOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: cycling exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in total body fat mass (Dual X ray Absorptiometry)
Measured: before and after the 12 weeks training program
Secondary outcomes (12)
aerobic capacities (VO2max)
Measured: before and after the 12 weeks training program
isometric muscular lower limbs strength
Measured: before and after the 12 weeks training program
isokinetic muscular lower limbs strength
Measured: before and after the 12 weeks training program
rest energy expenditure (indirect calorimetry)
Measured: before and after the 12 weeks training program
biological parameters (plasma lipid profile)
Measured: before and after the 12 weeks training program
biological parameters (insulin-resistance)
Measured: before and after the 12 weeks training program
physical activity
(questionnaires)
Measured: before and after the 12 weeks training program
physical activity
(actimetry)
Measured: before and after the 12 weeks training program
food intakes
(measurements)
Measured: before and after the 12 weeks training program
food intakes
(questionnaires)
Measured: before and after the 12 weeks training program
quality of life (questionnaires)
Measured: before and after the 12 weeks training program
segmental body composition
(segmental fat and fat free mass)
Measured: before and after the 12 weeks training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdultsStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie JULIAN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938117
- Sponsor's protocol ID
- CHU-0284
- Other IDs
- 2016-A01185-46
- Acronym
- OPEX
- Status last verified
- Oct 2016
- First submitted
- 10 Oct 2016
- Last updated
- 19 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Training Program on the Body Composition of Overweight and Obese Young Adults : Concentric Versus Eccentric Exercise
- ClinicalTrials.gov ID
- NCT02938117
- Acronym / sponsor ID
- OPEX / CHU-0284
- Keywords
- obesity, eccentric exercise, body composition, training program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CON : concentric cycling exercise | Experimental | Other: cycling exercisesThirty 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 |
| EXC : eccentric cycling exercise | Experimental | Other: cycling exercisesThirty 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- - 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
Key exclusion criteria (1 listed)
- (BMI<35)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cycling exercises | Other | CON : concentric cycling exercise, EXC : eccentric cycling exercise |
Primary outcome
change in total body fat mass (Dual X ray Absorptiometry)
Time frame: before and after the 12 weeks training program
12 secondary outcomes
aerobic capacities (VO2max)
Time frame: before and after the 12 weeks training program
isometric muscular lower limbs strength
Time frame: before and after the 12 weeks training program
isokinetic muscular lower limbs strength
Time frame: before and after the 12 weeks training program
rest energy expenditure (indirect calorimetry)
Time frame: before and after the 12 weeks training program
biological parameters (plasma lipid profile)
Time frame: before and after the 12 weeks training program
biological parameters (insulin-resistance)
Time frame: before and after the 12 weeks training program
physical activity
Time frame: before and after the 12 weeks training program
physical activity
Time frame: before and after the 12 weeks training program
food intakes
Time frame: before and after the 12 weeks training program
food intakes
Time frame: before and after the 12 weeks training program
quality of life (questionnaires)
Time frame: before and after the 12 weeks training program
segmental body composition
Time frame: before and after the 12 weeks training program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie JULIAN principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cycling exercises in people with Adults and BMI>35, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in total body fat mass (Dual X ray Absorptiometry) (time frame: before and after the 12 weeks training program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2016.