Multiple SclerosisNCT07316764
Eccentric Cycling in Multiple Sclerosis Rehabilitation
A study testing Eccentric training and Concentric training in people with Multiple Sclerosis and Rehabilitation, run by University of Liege at 1 site in Belgium.
Trial summary
The project aims to optimise functional rehabilitation programmes for people with multiple sclerosis. Investigators are proposing eccentric cycling as a new exercise modality for treating these patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis, Rehabilitation, Neuro-Degenerative Disease
- What is being tested?
- Eccentric training and Concentric training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Mar 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of multiple sclerosis
- Multiple sclerosis: EDSS score < 7
- Age under 75 years
- Stable disease state
- Written medical clearance authorizing participation
- Legal adult status
- Written informed consent, with demonstrated understanding of the consent form (via a few specific questions)
- Ability to mobilize independently (e.g., transfers, walking)
Who cannot join
- One or more contraindications to physical activity
- Significant comorbidities
- Active flare-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eccentric Cycling : a New Training Modality in Multiple Sclerosis Rehabilitation
The project aims to optimise functional rehabilitation programmes for people with multiple sclerosis.
Investigators are proposing eccentric cycling as a new exercise modality for treating these patients.
Based on previous results in healthy subjects, investigators will attempt to define the optimal parameters of this new modality (in terms of duration, intensity, frequency, etc.).
Investigators also aim to demonstrate the effectiveness of this training (compared to conventional training) in improving muscle function, functional capacity, perception of chronic fatigue, quality of life, physical condition, and neurological and cognitive function.
Read the detailed description
Our study will focus on multiple sclerosis. For each pathology included, a "control" group will consist of patients undergoing a traditional rehabilitation program combined with a concentric cycling session. An experimental group ("eccentric rehabilitation") will consist of patients enrolled in an eccentric ergocycle training protocol paired with standard rehabilitation. In practice, a portion of the classical rehabilitation program will be replaced by either concentric or eccentric cycling, for a maximum duration of 30 minutes. Based on a preliminary study conducted in healthy subjects, a review of the existing literature, and a sample size calculation performed by the Biostatistics Department of the University Hospital of Liège, investigators aim to recruit 60 to 80 subjects per pathology (details in the appendix). Participation of pregnant women is permitted.
Type of Study
This is a prospective interventional study conducted longitudinally, with all subjects evaluated over the same time period (2025-2027). The study will take place at the Sart-Tilman sites (Blanc-Gravier, Exercise Physiology Unit) or at the CNRF in Fraiture-en-Condroz, depending on participant preference.
Neurological Pathologies Inclusion criteria
Participants must:
present with one of the following neurological disorders: Parkinson's disease or multiple sclerosis.
- Eccentric Rehabilitation Program
Given the increasing clinical interest in eccentric contraction modalities for chronic diseases, a semi-recumbent eccentric ergometer has been specifically designed for clinical use. Patient installation on this device is safe and easily achievable, and the semi-recumbent position provides additional comfort during exercise. The ergometer allows secure workload control via visual feedback powered by dedicated software. The device can be transported between sites (Sart-Tilman - Fraiture - Esneux).
Experimental Protocol
This experimental study aims to establish and compare the effects of an eccentric cycling training protocol versus a traditional concentric cycling protocol performed on an ergometric bicycle. Subjects will be randomly allocated (stratified by sex and disease stage) into one of the two experimental groups. Randomization will be conducted by Mr. Benoît Vandenbroeck after encoding the relevant data in a table and assigning subjects within each stratum using random distribution.
Ambulatory participants will undergo a 2-week evaluation period followed by a 12-week training program consisting of two sessions per week, for a total of 28 sessions. In-hospitalisation participants will undergo a 1-week evaluation period (3 sessions), followed by 12 cycling training sessions and a 3 last sessions of evaluation, over a 4-week period, for a total of 18 sessions. Sessions will take place either at the Neurological and Functional Rehabilitation Center in Fraiture-en-Condroz (CNRF) or at Blanc-Gravier (Sart-Tilman), according to participant preference. Training sessions (eccentric or concentric) will last a maximum of 30 minutes. For participants already enrolled in a rehabilitation program at the CNRF, part of their traditional session will be replaced by the cycling training.
The unusual nature of eccentric training may induce mild delayed-onset muscle soreness (DOMS), including pain and stiffness, appearing 24-48 hours after exercise. These symptoms are transient, and symptomatic treatments (analgesics, stretching, ice) are not permitted.
Multiple variables will be assessed before, during, and after the intervention period to quantify potential effects of each training protocol and allow direct comparison.
Description of Study Phases
The study consists of 5 phases over a 12-week period for ambulatory participants and a 4-week period for in-hospitalisation participants (see appendix):
Phase 0: Baseline Testing
Out participants : Measurements will be collected 5-7 days before and 7-14 days after the training period to monitor longitudinal changes and evaluate the impact of the protocols on body composition and functional capacity.
In participants : Measurements will be collected the fisrt and lest (4th) week of the training program.
Eccentric Ergocycle Training Protocol Phase 1: Familiarization (4 weeks)
Out participants:
Two sessions per week for four weeks.
In participants:
Three sessions per week for two weeks. The main objective is to familiarize subjects with eccentric cycling and its specific neuromuscular demands, thus limiting potential muscle damage. Duration and intensity will gradually increase. To progress to the training phase, subjects must maintain an average power output within ±10% of their target theoretical power during the final familiarization session. If needed, one to two additional weeks of familiarization may be added. Beyond this point, participants unable to meet the criteria will be withdrawn from the study.
Phase 2: Training (Part 1 - 4 weeks)
Out:
These four weeks establish the first phase of training, with predefined duration and intensity levels.
In:
Two weeks with three training a week, with predefined duration and intensity levels.
Phase 3: Training (Part 2 - 4 weeks)
Out:
An additional four weeks are included, based on evidence showing greater benefits after 8-12 weeks of training. Intensity will be increased during this phase.
In:
An additional week (with three sessions) is included with an increased intensity.
Throughout the 12-week training period, temporal progression and identification of potential physiological adaptations will be monitored.
Phase 4: Final Testing
Out:
Participants will return to the laboratory twice to repeat the baseline assessments. These tests will be performed 7-10 days after the final training session to ensure adequate muscle recovery.
In:
Participants will take the three last evaluation sessions during the last (4th) week of the program.
- Being tested
- Eccentric training, Concentric training
- Keywords
- eccentric cycling, multiple sclerosis, eccentric training, neurorehabilitation, physical therapy, neuro-degenerative disease
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric trainingOther
Eccentric cycling training
Concentric trainingOther
Concentric cycling training
| Study group | Role | What they receive |
|---|---|---|
| Eccentric group | Experimental | Not described Receives: Other: Eccentric training |
| Concentric group | Active comparator | Not described Receives: Other: Concentric training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Isometric Force
Maximal Isometric Force (in Newton-meters - Nm) of the quadriceps will be measured using a fixed dynamometer (Kinvent), at 90 degrees of knee flexion.
Measured: At baseline and endline of intervention (Week 1 and 14)
Walking distance
6 minutes walking test and 2 minutes walking test will be performed to measure the walking capacities (in meters) of participants.
Measured: At baseline and endline of intervention (Week 1 and 14)
Glial Fibrillary Acidic Protein (GFAP)
Blood samples will be collected to analyse GFAP concentration. This specific biomarker reflect chronic astrocytic activation, glial scarring, and track Progression Independent of Relapse Activity (PIRA) as well as diffuse, underlying neurodegeneration.
Measured: At baseline and endline of intervention (Week 1 and 4)
Neurofilament Light Chain (NfL)
NfL is a structural component of nerve fibers (axons). Elevated levels in the blood reflect acute axonal injury, focal inflammatory activity, and help predict upcoming relapses.
Measured: At baseline and endline of intervention (week 1 and 4)
Secondary outcomes (12)
Handgrip strength
Handgrip strength (in kilograms) will be measured using a handheld dynamometer.
Measured: At baseline and endline of intervention (Week 1 and 14)
Spasticity
Spasticity will be evaluated using the Tardieu's scale of spasticity (expressed in arbitrary unit).
This scale ranges from 0 (no resistance) to 4 (immobile)
Measured: At baseline and endline of intervention (Week 1 and 14)
Timed up and go
The TUAG (in seconds) will be used to evaluate lower limb functional capacity
Measured: At baseline and endline of intervention (Week 1 and 14)
Neurocognitive capacity
Neurocognitive capacity will be evaluated using a combinaison of Tests of Attentional Performance battery (TAP battery)
Measured: At baseline and endline of intervention (Week 1 and 14)
Berg Balance Scale
The balance test will be used to evaluate balance capacity (expressed in arbitrary unit). This scale ranges from 0 (High fall risk) to 56 (no fall risk)
Measured: At baseline and endline of intervention (Week 1 and 14)
Five time sit to stand test
The sit to stand test (in seconds) will be performed to measure lower limb functional capacity
Measured: At baseline and endline of intervention (Week 1 and 14)
Maximal aerobic power
Maximal aerobic power (in Watts) will be evaluated by performing a Cardiopulmonary Exercise Test on an ergocycle.
Measured: At baseline and endline of intervention (Week 1 and 14)
Maximal oxygen consumption
Oxygen consumption (in milliliter per minute per kilogram ) will be evaluated by performing a cardiopulmonary exercise test on an ergometer.
Measured: At baseline and endline of intervention (Week 1 and 14)
Fatigue
Fatigue will be evaluated using the modified fatigue impact scale (MFIS) (expressed in arbitrary unit). This scale present different item that should be ranged from 0 (never) to 4 (always). We will collect the physical aspect with a maximal score ranginig from 0 (no fatigue) to 36 (exhausted)
Measured: At baseline and endline of intervention (Week 1 and 14)
Multiple Sclerosis Quality of Life-54
Quality of life will be evaluated using the Multiple Sclerosis Quality of Life-54 (MSQoL-54). This scale will be expressed in percent.
Measured: At baseline and endline of intervention (Week 1 and 14)
Maximal heart rate
Maximal heart brate (in beats per minute) will be measured by performing a cardiopulmonary exercise test on an ergocycle.
Measured: At baseline and endline of intervention (Week 1 and 14)
Posturographic data
K-Force Plates (Kinvent) will allow us to assess both static and dynamic balance in order to objectively evaluate postural control, stability, and asymmetries.
Measured: At baseline and endline of intervention (week 1 and 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start27 Mar 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be split in 2 groups : one following an eccentric cycling training one following a concentric cycling training
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Sart Tilman, Liege
- Responsible party
- Principal investigator, Vandenbroeck Benoit, University of Liege
- Investigators
- Stéphanie HODY, PhD, Study chair, Department of Physical Activity and Rehabilitation Sciences, University of Liege and University Hospital of Liege, Liege, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316764
- Sponsor's protocol ID
- 2025-416
- Status last verified
- Oct 2026
- First submitted
- 8 Dec 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eccentric Cycling : a New Training Modality in Multiple Sclerosis Rehabilitation
- ClinicalTrials.gov ID
- NCT07316764
- Acronym / sponsor ID
- 2025-416
- Keywords
- eccentric cycling, multiple sclerosis, eccentric training, neurorehabilitation, physical therapy, neuro-degenerative disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- University Hospital Sart Tilman, Liege
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 5 Jan 2026 (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 project aims to optimise functional rehabilitation programmes for people with multiple sclerosis.
Investigators are proposing eccentric cycling as a new exercise modality for treating these patients.
Based on previous results in healthy subjects, investigators will attempt to define the optimal parameters of this new modality (in terms of duration, intensity, frequency, etc.).
Investigators also aim to demonstrate the effectiveness of this training (compared to conventional training) in improving muscle function, functional capacity, perception of chronic fatigue, quality of life, physical condition, and neurological and cognitive function.
Detailed description
Our study will focus on multiple sclerosis. For each pathology included, a "control" group will consist of patients undergoing a traditional rehabilitation program combined with a concentric cycling session. An experimental group ("eccentric rehabilitation") will consist of patients enrolled in an eccentric ergocycle training protocol paired with standard rehabilitation. In practice, a portion of the classical rehabilitation program will be replaced by either concentric or eccentric cycling, for a maximum duration of 30 minutes. Based on a preliminary study conducted in healthy subjects, a review of the existing literature, and a sample size calculation performed by the Biostatistics Department of the University Hospital of Liège, investigators aim to recruit 60 to 80 subjects per pathology (details in the appendix). Participation of pregnant women is permitted.
Type of Study
This is a prospective interventional study conducted longitudinally, with all subjects evaluated over the same time period (2025-2027). The study will take place at the Sart-Tilman sites (Blanc-Gravier, Exercise Physiology Unit) or at the CNRF in Fraiture-en-Condroz, depending on participant preference.
Neurological Pathologies Inclusion criteria
Participants must:
present with one of the following neurological disorders: Parkinson's disease or multiple sclerosis.
- Eccentric Rehabilitation Program
Given the increasing clinical interest in eccentric contraction modalities for chronic diseases, a semi-recumbent eccentric ergometer has been specifically designed for clinical use. Patient installation on this device is safe and easily achievable, and the semi-recumbent position provides additional comfort during exercise. The ergometer allows secure workload control via visual feedback powered by dedicated software. The device can be transported between sites (Sart-Tilman - Fraiture - Esneux).
Experimental Protocol
This experimental study aims to establish and compare the effects of an eccentric cycling training protocol versus a traditional concentric cycling protocol performed on an ergometric bicycle. Subjects will be randomly allocated (stratified by sex and disease stage) into one of the two experimental groups. Randomization will be conducted by Mr. Benoît Vandenbroeck after encoding the relevant data in a table and assigning subjects within each stratum using random distribution.
Ambulatory participants will undergo a 2-week evaluation period followed by a 12-week training program consisting of two sessions per week, for a total of 28 sessions. In-hospitalisation participants will undergo a 1-week evaluation period (3 sessions), followed by 12 cycling training sessions and a 3 last sessions of evaluation, over a 4-week period, for a total of 18 sessions. Sessions will take place either at the Neurological and Functional Rehabilitation Center in Fraiture-en-Condroz (CNRF) or at Blanc-Gravier (Sart-Tilman), according to participant preference. Training sessions (eccentric or concentric) will last a maximum of 30 minutes. For participants already enrolled in a rehabilitation program at the CNRF, part of their traditional session will be replaced by the cycling training.
The unusual nature of eccentric training may induce mild delayed-onset muscle soreness (DOMS), including pain and stiffness, appearing 24-48 hours after exercise. These symptoms are transient, and symptomatic treatments (analgesics, stretching, ice) are not permitted.
Multiple variables will be assessed before, during, and after the intervention period to quantify potential effects of each training protocol and allow direct comparison.
Description of Study Phases
The study consists of 5 phases over a 12-week period for ambulatory participants and a 4-week period for in-hospitalisation participants (see appendix):
Phase 0: Baseline Testing
Out participants : Measurements will be collected 5-7 days before and 7-14 days after the training period to monitor longitudinal changes and evaluate the impact of the protocols on body composition and functional capacity.
In participants : Measurements will be collected the fisrt and lest (4th) week of the training program.
Eccentric Ergocycle Training Protocol Phase 1: Familiarization (4 weeks)
Out participants:
Two sessions per week for four weeks.
In participants:
Three sessions per week for two weeks. The main objective is to familiarize subjects with eccentric cycling and its specific neuromuscular demands, thus limiting potential muscle damage. Duration and intensity will gradually increase. To progress to the training phase, subjects must maintain an average power output within ±10% of their target theoretical power during the final familiarization session. If needed, one to two additional weeks of familiarization may be added. Beyond this point, participants unable to meet the criteria will be withdrawn from the study.
Phase 2: Training (Part 1 - 4 weeks)
Out:
These four weeks establish the first phase of training, with predefined duration and intensity levels.
In:
Two weeks with three training a week, with predefined duration and intensity levels.
Phase 3: Training (Part 2 - 4 weeks)
Out:
An additional four weeks are included, based on evidence showing greater benefits after 8-12 weeks of training. Intensity will be increased during this phase.
In:
An additional week (with three sessions) is included with an increased intensity.
Throughout the 12-week training period, temporal progression and identification of potential physiological adaptations will be monitored.
Phase 4: Final Testing
Out:
Participants will return to the laboratory twice to repeat the baseline assessments. These tests will be performed 7-10 days after the final training session to ensure adequate muscle recovery.
In:
Participants will take the three last evaluation sessions during the last (4th) week of the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be split in 2 groups : one following an eccentric cycling training one following a concentric cycling training
| Arm | Type | Receives |
|---|---|---|
| Eccentric group | Experimental | Other: Eccentric training |
| Concentric group | Active comparator | Other: Concentric training |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of multiple sclerosis
- Multiple sclerosis: EDSS score < 7
- Age under 75 years
- Stable disease state
- Written medical clearance authorizing participation
Key exclusion criteria (3 listed)
- One or more contraindications to physical activity
- Significant comorbidities
- Active flare-up
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 |
|---|---|---|
| Eccentric trainingEccentric cycling training | Other | Eccentric group |
| Concentric trainingConcentric cycling training | Other | Concentric group |
Primary outcome
Maximal Isometric Force
Time frame: At baseline and endline of intervention (Week 1 and 14)
Maximal Isometric Force (in Newton-meters - Nm) of the quadriceps will be measured using a fixed dynamometer (Kinvent), at 90 degrees of knee flexion.
Walking distance
Time frame: At baseline and endline of intervention (Week 1 and 14)
6 minutes walking test and 2 minutes walking test will be performed to measure the walking capacities (in meters) of participants.
Glial Fibrillary Acidic Protein (GFAP)
Time frame: At baseline and endline of intervention (Week 1 and 4)
Blood samples will be collected to analyse GFAP concentration. This specific biomarker reflect chronic astrocytic activation, glial scarring, and track Progression Independent of Relapse Activity (PIRA) as well as diffuse, underlying neurodegeneration.
Neurofilament Light Chain (NfL)
Time frame: At baseline and endline of intervention (week 1 and 4)
NfL is a structural component of nerve fibers (axons). Elevated levels in the blood reflect acute axonal injury, focal inflammatory activity, and help predict upcoming relapses.
12 secondary outcomes
Handgrip strength
Time frame: At baseline and endline of intervention (Week 1 and 14)
Spasticity
Time frame: At baseline and endline of intervention (Week 1 and 14)
Timed up and go
Time frame: At baseline and endline of intervention (Week 1 and 14)
Neurocognitive capacity
Time frame: At baseline and endline of intervention (Week 1 and 14)
Berg Balance Scale
Time frame: At baseline and endline of intervention (Week 1 and 14)
Five time sit to stand test
Time frame: At baseline and endline of intervention (Week 1 and 14)
Maximal aerobic power
Time frame: At baseline and endline of intervention (Week 1 and 14)
Maximal oxygen consumption
Time frame: At baseline and endline of intervention (Week 1 and 14)
Fatigue
Time frame: At baseline and endline of intervention (Week 1 and 14)
Multiple Sclerosis Quality of Life-54
Time frame: At baseline and endline of intervention (Week 1 and 14)
Maximal heart rate
Time frame: At baseline and endline of intervention (Week 1 and 14)
Posturographic data
Time frame: At baseline and endline of intervention (week 1 and 4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Stéphanie HODY, PhD study chair
Department of Physical Activity and Rehabilitation Sciences, University of Liege and University Hospital of Liege, Liege, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric training and Concentric training in people with Multiple Sclerosis and Rehabilitation, run by University of Liege at 1 site in Belgium.
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 8 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Isometric Force (time frame: At baseline and endline of intervention (Week 1 and 14)). The study lists 4 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 6 Oct 2026.