Healthy Control SubjectsOPTIMEXNCT06193824
Optimisation of Eccentric Exercises
A study testing Experimental: downhill treadmill walking at -10% and -20% gradient in people with Healthy Control Subjects, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Regular physical activity is an important public health lever and is recognised as an alternative in the management of certain long-term conditions. To achieve beneficial effects on the body, exercise recommendations are based on several parameters such as duration, intensity and continuous or intermittent nature of… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Control Subjects
- What is being tested?
- Experimental: downhill treadmill walking at -10% and -20% gradient
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2023to Dec 2024
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index between 18.5 and 24.9 kg/m² (18.5 ≤ BMI ≤ 24.9)
- Non-smoker
- No treatment (background or at the time of the examination)
- Physical check up considered compatible with study participation (no bones, articular or muscular problems in lower limbs)
- Subjects considered healthy by investigator based on medical questioning and clinical examination
- Affiliation to the French Social Security system
- Person who has read and understood the research-related information, and signed the consent forms
Who cannot join
- Smoking
- Subjects with heart or respiratory failure
- Participants with lower extremity injury in the past three months
- Contraindication to the application of a magnetic field (wearing a pacemaker, presence of prosthetic material or ferromagnetic foreign bodies, presence of cochlear implants or ocular prosthetic material)
- Participant that does not wish to participate (refusal to sign the consent form)
- Patients under guardianship, trusteeship, deprived of liberty or safeguard of justice
Trial locations and contacts
1 site in 1 country.
Fabrice Rannou contact
France1 site, 1 recruiting
- Recruiting
Chu Clermont Ferrand
Clermont-Ferrand
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
Fabrice Rannou
About this study
Official title: Characterization of the Endocrine Response to Exercise: Impact of the Muscle Contraction Modality
Regular physical activity is an important public health lever and is recognised as an alternative in the management of certain long-term conditions. To achieve beneficial effects on the body, exercise recommendations are based on several parameters such as duration, intensity and continuous or intermittent nature of the activity. However, the mode of muscle contraction during exercise is generally little considered or poorly defined in these recommendations, which can lead to prescribing errors. In particular, the eccentric contraction modality, which can be found in actions designed to slow down movement (e.g. walking downhill), represents an interesting strategy, but its prescription modalities are still poorly understood.
The beneficial effects of physical activity are based in part on the release of molecules (myokines) by the skeletal muscles during exercise, which improve the functioning of the body. However, the effect of downhill walking on the release of myokines by the muscle has been little studied. The lack of knowledge of this effect is therefore an obstacle to the use of this exercise modality to try to optimise physical activity recommendations for health or performance improvement.
The aim of this study is therefore to better understand how downhill walking (eccentric muscle contraction) affects the production of molecules by muscles (myokines) during exercise.
Read the detailed description
After being informed of the aims, nature and possible risks of the study, written informed consent will be obtained from the subjects.
Prior to enrolment, volunteers will undergo a medical evaluation that includes a review of personal and family medical history, any current medications, and a standard physical examination. Compliance with the inclusion/exclusion criteria will be checked during this examination.
After enrolment, subjects will perform a treadmill familiarization session.
Experimental days:
- Subjects will complete a 45-minute walking exercise on a negative gradient treadmill (6 km/h) in a randomised 2-way cross-over design with either a -10% or -20% gradient.
- Blood will be sampled immediately pre-exercise, 1-h and 24-h post-exercise for the analysis of muscle myokines.
- Exercise-induced muscle fatigue in lower limbs will be evaluated using squat and counter-movement jumps immediately before and post-exercise.
- Heart-rate variability will be measured during the eccentric exercise session.
- Thigh muscle volume will be measured immediately before and post-exercise.
- Exercise-induced myalgia at 24-, 48-, 72- and 96h will be assessed using a visual analogue scale.
- Conditions
- Healthy Control Subjects
- Being tested
- Experimental: downhill treadmill walking at -10% and -20% gradient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: downhill treadmill walking at -10% and -20% gradientDevice
The subjects will perform downhill walking at 6 km/h for 45 min on a treadmill (-10% or -20% incline)
| Study group | Role | What they receive |
|---|---|---|
| downhill treadmill walking -10% gradient | Experimental | The subjects will perform downhill walking at 6 km/h for 45 min on a treadmill (-10% incline) Receives: Device: Experimental: downhill treadmill walking at -10% and -20% gradient |
| downhill treadmill walking -20% gradient | Experimental | The subjects will perform downhill walking at 6 km/h for 45 min on a treadmill (-20% incline) Receives: Device: Experimental: downhill treadmill walking at -10% and -20% gradient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of eccentric exercise on myokine concentrations
Changes in systemic myokine levels following submaximal downhill treadmill exercise at different inclines, at the same speed and for the same duration.
Measured: Blood sample at baseline (prior exercise), Hour 1 and Hour 24 post-exercise
Effect of treadmill inclination on myokine concentrations
Differences in systemic myokine levels concentrations following -10 and -20% gradient submaximal downhill treadmill exercises, at the same speed and for the same duration.
Measured: Blood sample at baseline (prior exercise), Hour 1 and Hour 24 post-exercise
Secondary outcomes (6)
Assessment of exercise-induced muscle fatigue in lower limbs
squat jump
Measured: Baseline (prior exercise) and 15 seconds post-exercise
Assessment of exercise-induced muscle fatigue in lower limbs
counter-movement jump
Measured: Baseline (prior exercise) and 15 seconds post-exercise
Assessment of autonomic nervous system function
Heart rate variability (HRV) analysis Temporal and spectral analyses of cardiac variability
Measured: During treadmill exercise
Effect of treadmill exercise on muscle volume
Measurement of thigh and calf circumferences
Measured: Baseline (prior exercise) and 15 seconds post-exercise
Effect of treadmill exercise on muscle pain
Measurement of muscle pain induced by a half-squat movement (self-measurement by the subject using a visual analogic scale, 0-10)
Measured: Baseline (prior exercise) and 15 seconds post-exercise
Effect of treadmill exercise on delayed onset muscle soreness
Measurement of muscle pain induced by eccentric exercise (self-measurement by the subject using a visual analogic scale, 0-10)
Measured: Baseline (prior exercise) and Hour 24, Hour 48, Hour 72, Hour 96 post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start4 May 2023
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Control SubjectsStudies of the same condition, open and under way.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193824
- Sponsor's protocol ID
- RBHP 2022 RANNOU
- Acronym
- OPTIMEX
- Status last verified
- May 2023
- First submitted
- 23 Jun 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Endocrine Response to Exercise: Impact of the Muscle Contraction Modality
- ClinicalTrials.gov ID
- NCT06193824
- Acronym / sponsor ID
- OPTIMEX / RBHP 2022 RANNOU
- Conditions
- Healthy Control Subjects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Jan 2024 (actual)
- 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.
Regular physical activity is an important public health lever and is recognised as an alternative in the management of certain long-term conditions. To achieve beneficial effects on the body, exercise recommendations are based on several parameters such as duration, intensity and continuous or intermittent nature of the activity. However, the mode of muscle contraction during exercise is generally little considered or poorly defined in these recommendations, which can lead to prescribing errors. In particular, the eccentric contraction modality, which can be found in actions designed to slow down movement (e.g. walking downhill), represents an interesting strategy, but its prescription modalities are still poorly understood.
The beneficial effects of physical activity are based in part on the release of molecules (myokines) by the skeletal muscles during exercise, which improve the functioning of the body. However, the effect of downhill walking on the release of myokines by the muscle has been little studied. The lack of knowledge of this effect is therefore an obstacle to the use of this exercise modality to try to optimise physical activity recommendations for health or performance improvement.
The aim of this study is therefore to better understand how downhill walking (eccentric muscle contraction) affects the production of molecules by muscles (myokines) during exercise.
Detailed description
After being informed of the aims, nature and possible risks of the study, written informed consent will be obtained from the subjects.
Prior to enrolment, volunteers will undergo a medical evaluation that includes a review of personal and family medical history, any current medications, and a standard physical examination. Compliance with the inclusion/exclusion criteria will be checked during this examination.
After enrolment, subjects will perform a treadmill familiarization session.
Experimental days:
- Subjects will complete a 45-minute walking exercise on a negative gradient treadmill (6 km/h) in a randomised 2-way cross-over design with either a -10% or -20% gradient.
- Blood will be sampled immediately pre-exercise, 1-h and 24-h post-exercise for the analysis of muscle myokines.
- Exercise-induced muscle fatigue in lower limbs will be evaluated using squat and counter-movement jumps immediately before and post-exercise.
- Heart-rate variability will be measured during the eccentric exercise session.
- Thigh muscle volume will be measured immediately before and post-exercise.
- Exercise-induced myalgia at 24-, 48-, 72- and 96h will be assessed using a visual analogue scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| downhill treadmill walking -10% gradient | Experimental | Device: Experimental: downhill treadmill walking at -10% and -20% gradientThe subjects will perform downhill walking at 6 km/h for 45 min on a treadmill (-10% incline) |
| downhill treadmill walking -20% gradient | Experimental | Device: Experimental: downhill treadmill walking at -10% and -20% gradientThe subjects will perform downhill walking at 6 km/h for 45 min on a treadmill (-20% incline) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Body Mass Index between 18.5 and 24.9 kg/m² (18.5 ≤ BMI ≤ 24.9)
- Non-smoker
- No treatment (background or at the time of the examination)
- Physical check up considered compatible with study participation (no bones, articular or muscular problems in lower limbs)
- Subjects considered healthy by investigator based on medical questioning and clinical examination
Key exclusion criteria (6 listed)
- Smoking
- Subjects with heart or respiratory failure
- Participants with lower extremity injury in the past three months
- Contraindication to the application of a magnetic field (wearing a pacemaker, presence of prosthetic material or ferromagnetic foreign bodies, presence of cochlear implants or ocular prosthetic material)
- Participant that does not wish to participate (refusal to sign the consent form)
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 |
|---|---|---|
| Experimental: downhill treadmill walking at -10% and -20% gradientThe subjects will perform downhill walking at 6 km/h for 45 min on a treadmill (-10% or -20% incline) | Device | downhill treadmill walking -10% gradient, downhill treadmill walking -20% gradient |
Primary outcome
Effect of eccentric exercise on myokine concentrations
Time frame: Blood sample at baseline (prior exercise), Hour 1 and Hour 24 post-exercise
Changes in systemic myokine levels following submaximal downhill treadmill exercise at different inclines, at the same speed and for the same duration.
Effect of treadmill inclination on myokine concentrations
Time frame: Blood sample at baseline (prior exercise), Hour 1 and Hour 24 post-exercise
Differences in systemic myokine levels concentrations following -10 and -20% gradient submaximal downhill treadmill exercises, at the same speed and for the same duration.
6 secondary outcomes
Assessment of exercise-induced muscle fatigue in lower limbs
Time frame: Baseline (prior exercise) and 15 seconds post-exercise
Assessment of exercise-induced muscle fatigue in lower limbs
Time frame: Baseline (prior exercise) and 15 seconds post-exercise
Assessment of autonomic nervous system function
Time frame: During treadmill exercise
Effect of treadmill exercise on muscle volume
Time frame: Baseline (prior exercise) and 15 seconds post-exercise
Effect of treadmill exercise on muscle pain
Time frame: Baseline (prior exercise) and 15 seconds post-exercise
Effect of treadmill exercise on delayed onset muscle soreness
Time frame: Baseline (prior exercise) and Hour 24, Hour 48, Hour 72, Hour 96 post-exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
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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.
Fabrice Rannou contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: downhill treadmill walking at -10% and -20% gradient in people with Healthy Control Subjects, 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 7 inclusion and 6 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 11 Jan 2024. 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 Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of eccentric exercise on myokine concentrations (time frame: Blood sample at baseline (prior exercise), Hour 1 and Hour 24 post-exercise). The study lists 2 primary outcomes in all. 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 11 Jan 2024.