Volunteers Who Can do Moderate Physical ActivityExo-Mode 3NCT04886115
Effects of Eccentric Pedaling at Different Rates on Neuromuscular Function
A study testing Neuromuscular evaluation, Assessment of aerobic capacity, muscle architecture and habituation to the eccentric pedaling task and Pedaling at 15 rpm in people with Volunteers Who Can do Moderate Physical Activity, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The recent appearance of ergocycles that can be used for eccentric pedaling (Cyclus type) has aroused a growing interest in the field of rehabilitation. The mechanical, metabolic, and cardiorespiratory characteristics of eccentric exercises make them an exercise of choice when the goal is to improve locomotor muscle… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Volunteers Who Can do Moderate Physical Activity
- What is being tested?
- Neuromuscular evaluation, Assessment of aerobic capacity, muscle architecture and habituation to the eccentric pedaling task and Pedaling at 15 rpm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2022to Jun 2025
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Person who has given oral consent
- Subject capable of understanding simple commands and giving consent
- Subject (male or female) between 18 and 40 years of age.
- Subject able to do moderate physical activity
Who cannot join
- Person not affiliated to national health insurance.
- Physical disabilities affecting the lower limbs or the pelvis, and which may hinder or prevent the practice of exercise on an ergocycle, whether neurological (central or peripheral), arterial (in particular, arterial disease of the lower limbs with a systolic index < 0.6) or orthopedic (degenerative or inflammatory rheumatism).
- Person under legal protection (curatorship, guardianship)
- Person under court order (sauvegarde de justice)
- Pregnant, parturient or breastfeeding women
- Major unable to express consent
- Minor
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Davy LAROCHE, 03 80 29 56 65, davy.laroche@chu-dijon.fr
About this study
The recent appearance of ergocycles that can be used for eccentric pedaling (Cyclus type) has aroused a growing interest in the field of rehabilitation. The mechanical, metabolic, and cardiorespiratory characteristics of eccentric exercises make them an exercise of choice when the goal is to improve locomotor muscle function and exercise capacity. Despite its potential advantages, the optimal modalities of eccentric pedaling, in particular the choice of pedaling frequency, are still poorly understood, especially its effects on the neuromuscular system. Indeed, most training protocols impose a fixed pedaling power but with highly variable pedaling rates, ranging from 15 to 60 rpm (Besson et al., 2013; MacMillan et al., 2017). For a given pedaling power level (P), the choice of pedaling frequency (F) directly impacts the force torque (C) and thus the force applied to the pedals, since power is equal to the product of pedaling frequency and force torque (P = F.C). For frequencies varying from 15 to 60 rpm, the level of muscular tension during pedaling therefore varies from single to quadruple. These very large variations in force can influence the neuromuscular adaptations induced during a prolonged training period. For example, the use of low pedaling frequencies corresponding to high muscle tension could favor peripheral muscular adaptations (e.g. contractility) whereas higher pedaling frequencies could favor central (i.e. nervous) adaptations.
A better understanding of the neuromuscular adaptations induced by a period of eccentric pedaling at different cadences will allow for a more precise definition of training protocols for populations likely to undergo this type of training (e.g. elderly people, patients with heart failure).
- Being tested
- Neuromuscular evaluation, Assessment of aerobic capacity, muscle architecture and habituation to the eccentric pedaling task, Pedaling at 15 rpm, No pedaling, usual activity, Pedaling at 60rpm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular evaluationOther
Before and after training.
Muscle function:
- voluntary maximal isometric force of the knee extensors
- evoked force in the knee extensors by double percutaneous electrical stimulation at 100 and 10 Hz
- level of voluntary activation
- voluntary maximum force in concentric and eccentric mode at an angular speed of 60°.s-1
- squat jump and counter-movement jump
Assessment of aerobic capacity, muscle architecture and habituation to the eccentric pedaling taskOther
Before and after training.
Cardiovascular-respiratory function:
- Oxygen consumption during the incremental concentric pedaling test conducted to high effort perception.
- heart rate during pedaling tasks
Muscle architecture:
- Pennation angle and thickness of vastus lateralis, rectus femoris, gastrocnemius medialis and lateralis muscles, before and after training.
Familiarization with eccentric pedaling
Pedaling at 15 rpmOther
3 training sessions per week for 6 weeks
No pedaling, usual activityOther
Maintain usual physical activity and diet for a period of 6 weeks.
Pedaling at 60rpmOther
3 sessions per week of training for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Eccentric pedalling group at 15 rpm | Experimental | Not described Receives: Other: Neuromuscular evaluation; Other: Assessment of aerobic capacity, muscle architecture and habituation to the eccentric pedaling task; Other: Pedaling at 15 rpm |
| Eccentric pedalling group at 60 rpm | Experimental | Not described Receives: Other: Neuromuscular evaluation; Other: Assessment of aerobic capacity, muscle architecture and habituation to the eccentric pedaling task; Other: Pedaling at 60rpm |
| Control | Active comparator | Not described Receives: Other: Neuromuscular evaluation; Other: Assessment of aerobic capacity, muscle architecture and habituation to the eccentric pedaling task; Other: No pedaling, usual activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum isometric force developed in the quadriceps
Measured: 6 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start7 Feb 2022
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volunteers Who Can do Moderate Physical ActivityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886115
- Sponsor's protocol ID
- LAROCHE 2021
- Acronym
- Exo-Mode 3
- Status last verified
- Feb 2024
- First submitted
- 10 May 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Eccentric Pedaling at Different Rates on Neuromuscular Function
- ClinicalTrials.gov ID
- NCT04886115
- Acronym / sponsor ID
- Exo-Mode 3 / LAROCHE 2021
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 13 May 2021 (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.
The recent appearance of ergocycles that can be used for eccentric pedaling (Cyclus type) has aroused a growing interest in the field of rehabilitation. The mechanical, metabolic, and cardiorespiratory characteristics of eccentric exercises make them an exercise of choice when the goal is to improve locomotor muscle function and exercise capacity. Despite its potential advantages, the optimal modalities of eccentric pedaling, in particular the choice of pedaling frequency, are still poorly understood, especially its effects on the neuromuscular system. Indeed, most training protocols impose a fixed pedaling power but with highly variable pedaling rates, ranging from 15 to 60 rpm (Besson et al., 2013; MacMillan et al., 2017). For a given pedaling power level (P), the choice of pedaling frequency (F) directly impacts the force torque (C) and thus the force applied to the pedals, since power is equal to the product of pedaling frequency and force torque (P = F.C). For frequencies varying from 15 to 60 rpm, the level of muscular tension during pedaling therefore varies from single to quadruple. These very large variations in force can influence the neuromuscular adaptations induced during a prolonged training period. For example, the use of low pedaling frequencies corresponding to high muscle tension could favor peripheral muscular adaptations (e.g. contractility) whereas higher pedaling frequencies could favor central (i.e. nervous) adaptations.
A better understanding of the neuromuscular adaptations induced by a period of eccentric pedaling at different cadences will allow for a more precise definition of training protocols for populations likely to undergo this type of training (e.g. elderly people, patients with heart failure).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eccentric pedalling group at 15 rpm | Experimental | Other: Neuromuscular evaluation, Other: Assessment of aerobic capacity, muscle architecture and habituation to the eccentric pedaling task, Other: Pedaling at 15 rpm |
| Eccentric pedalling group at 60 rpm | Experimental | Other: Neuromuscular evaluation, Other: Assessment of aerobic capacity, muscle architecture and habituation to the eccentric pedaling task, Other: Pedaling at 60rpm |
| Control | Active comparator | Other: Neuromuscular evaluation, Other: Assessment of aerobic capacity, muscle architecture and habituation to the eccentric pedaling task, Other: No pedaling, usual activity |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Person who has given oral consent
- Subject capable of understanding simple commands and giving consent
- Subject (male or female) between 18 and 40 years of age.
- Subject able to do moderate physical activity
Key exclusion criteria (7 listed)
- Person not affiliated to national health insurance.
- Physical disabilities affecting the lower limbs or the pelvis, and which may hinder or prevent the practice of exercise on an ergocycle, whether neurological (central or peripheral), arterial (in particular, arterial disease of the lower limbs with a systolic index < 0.6) or orthopedic (degenerative or inflammatory rheumatism).
- Person under legal protection (curatorship, guardianship)
- Person under court order (sauvegarde de justice)
- Pregnant, parturient or breastfeeding women
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 |
|---|---|---|
| Neuromuscular evaluationBefore and after training. Muscle function: * voluntary maximal isometric force of the knee extensors * evoked force in the knee extensors by double percutaneous electrical stimulation at 100 and 10 Hz * level of voluntary activation * voluntary maximum force in concentric and eccentric mode at an angular speed of 60°.s-1 * squat jump and counter-movement jump | Other | Control, Eccentric pedalling group at 15 rpm, Eccentric pedalling group at 60 rpm |
| Assessment of aerobic capacity, muscle architecture and habituation to the eccentric pedaling taskBefore and after training. Cardiovascular-respiratory function: * Oxygen consumption during the incremental concentric pedaling test conducted to high effort perception. * heart rate during pedaling tasks Muscle architecture: - Pennation angle and thickness of vastus lateralis, rectus femoris, gastrocnemius medialis and lateralis muscles, before and after training. Familiarization with eccentric pedaling | Other | Control, Eccentric pedalling group at 15 rpm, Eccentric pedalling group at 60 rpm |
| Pedaling at 15 rpm3 training sessions per week for 6 weeks | Other | Eccentric pedalling group at 15 rpm |
| No pedaling, usual activityMaintain usual physical activity and diet for a period of 6 weeks. | Other | Control |
| Pedaling at 60rpm3 sessions per week of training for 6 weeks | Other | Eccentric pedalling group at 60 rpm |
Primary outcome
Maximum isometric force developed in the quadriceps
Time frame: 6 weeks of training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular evaluation, Assessment of aerobic capacity, muscle architecture and habituation to the eccentric pedaling task and Pedaling at 15 rpm in people with Volunteers Who Can do Moderate Physical Activity, run by Centre Hospitalier Universitaire Dijon 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 7 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 20 Feb 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 Davy LAROCHE (03 80 29 56 65, davy.laroche@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum isometric force developed in the quadriceps (time frame: 6 weeks of training). 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 20 Feb 2024.