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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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.

Belgium1 site
  • Liege University

    Liège, Liège, 4000

Other trials in Belgium

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.

  1. 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 groups in NCT07316764
Study groupRoleWhat they receive
Eccentric groupExperimentalNot described
Receives: Other: Eccentric training
Concentric groupActive comparatorNot described
Receives: Other: Concentric training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  2. 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)

  3. 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)

  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)
  1. Handgrip strength

    Handgrip strength (in kilograms) will be measured using a handheld dynamometer.

    Measured: At baseline and endline of intervention (Week 1 and 14)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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.

  1. First posted5 Jan 2026
  2. Study start27 Mar 2026
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

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)
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

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.

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Eccentric Cycling in Multiple Sclerosis Rehabilitation | AzTrials