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Eksentrisk sykling i multippel sklerose-rehabilitering

1. oktober 2026 oppdatert av: Vandenbroeck Benoit, University of Liege

Eksentrisk sykling: En ny treningsmodus i rehabilitering ved multippel sklerose

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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

I. 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.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Liège
      • Liège, Liège, Belgia, 4000
        • Liege University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • One or more contraindications to physical activity
  • Significant comorbidities
  • Active flare-up

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Eksentrisk gruppe

Eccentric cycling training

Aktiv komparator: Konsentrisk gruppe

Concentric cycling training

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maximal Isometric Force
Tidsramme: 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.

At baseline and endline of intervention (Week 1 and 14)
Walking distance
Tidsramme: 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.

At baseline and endline of intervention (Week 1 and 14)
Glial Fibrillary Acidic Protein (GFAP)
Tidsramme: 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.

At baseline and endline of intervention (Week 1 and 4)
Neurofilament Light Chain (NfL)
Tidsramme: 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.

At baseline and endline of intervention (week 1 and 4)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Handgrip strength
Tidsramme: At baseline and endline of intervention (Week 1 and 14)

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

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

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)

At baseline and endline of intervention (Week 1 and 14)
Timed up and go
Tidsramme: At baseline and endline of intervention (Week 1 and 14)

The TUAG (in seconds) will be used to evaluate lower limb functional capacity

At baseline and endline of intervention (Week 1 and 14)
Neurocognitive capacity
Tidsramme: At baseline and endline of intervention (Week 1 and 14)

Neurocognitive capacity will be evaluated using a combinaison of Tests of Attentional Performance battery (TAP battery)

At baseline and endline of intervention (Week 1 and 14)
Berg Balance Scale
Tidsramme: At baseline and endline of intervention (Week 1 and 14)

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)

At baseline and endline of intervention (Week 1 and 14)
Five time sit to stand test
Tidsramme: At baseline and endline of intervention (Week 1 and 14)

The sit to stand test (in seconds) will be performed to measure lower limb functional capacity

At baseline and endline of intervention (Week 1 and 14)
Maximal aerobic power
Tidsramme: At baseline and endline of intervention (Week 1 and 14)

Maximal aerobic power (in Watts) will be evaluated by performing a Cardiopulmonary Exercise Test on an ergocycle.

At baseline and endline of intervention (Week 1 and 14)
Maximal oxygen consumption
Tidsramme: At baseline and endline of intervention (Week 1 and 14)

Oxygen consumption (in milliliter per minute per kilogram ) will be evaluated by performing a cardiopulmonary exercise test on an ergometer.

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

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)

At baseline and endline of intervention (Week 1 and 14)
Multiple Sclerosis Quality of Life-54
Tidsramme: At baseline and endline of intervention (Week 1 and 14)

Quality of life will be evaluated using the Multiple Sclerosis Quality of Life-54 (MSQoL-54). This scale will be expressed in percent.

At baseline and endline of intervention (Week 1 and 14)
Maximal heart rate
Tidsramme: At baseline and endline of intervention (Week 1 and 14)

Maximal heart brate (in beats per minute) will be measured by performing a cardiopulmonary exercise test on an ergocycle.

At baseline and endline of intervention (Week 1 and 14)
Posturographic data
Tidsramme: At baseline and endline of intervention (week 1 and 4)

K-Force Plates (Kinvent) will allow us to assess both static and dynamic balance in order to objectively evaluate postural control, stability, and asymmetries.

At baseline and endline of intervention (week 1 and 4)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Height
Tidsramme: At baseline and endline of intervention (Week 1 and 14)

Height will me measured and expressed in centimeters.

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

Weight in kilograms will be measured using a Tanita scale.

At baseline and endline of intervention (Week 1 and 14)
Body fat percentage
Tidsramme: At baseline and endline of intervention (Week 1 and 14)

Body fat percentage (in percent) will be measured using a Tanita scale.

At baseline and endline of intervention (Week 1 and 14)
Body mass index
Tidsramme: At baseline and endline of intervention (Week 1 and 14)

BMI (in kilograms per square meters) will be measured using the height and the weight (H/W^2).

At baseline and endline of intervention (Week 1 and 14)
Heart rate
Tidsramme: Throughout the entire intervention (week 2 to week 13)

Heart rate (in percent of max heart rate) will be analyzed during each training session

Throughout the entire intervention (week 2 to week 13)
Rating of perceived exertion
Tidsramme: Throughout the entire intervention (week 2 to week 13)

RPE (in arbitrary unit) will be evaluated using the Borg scale after each training session. Borg scale ranges from 6 (no exertion) to 20 (extremely hard).

Throughout the entire intervention (week 2 to week 13)
Mental demand
Tidsramme: Throughout the entire intervention (week 2 to week 13)

Mental demand of the training (in arbitrari unit) will be evaluated using a modified Borg scale after each training session. Modified Borg scale ranges from 0 (no exertion) to 10 (extremely hard).

Throughout the entire intervention (week 2 to week 13)
Muscle soreness
Tidsramme: Throughout the entire intervention (week 2 to week 13)

Muscle soreness (in arbitrary unit) will be evaluated using a visual analog scale before each training session. This scale ranges from 0 (no pain) to 10 (worst pain possible).

Throughout the entire intervention (week 2 to week 13)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Samarbeidspartnere

Etterforskere

  • Studiestol: Stéphanie HODY, PhD, Department of Physical Activity and Rehabilitation Sciences, University of Liege and University Hospital of Liege, Liege, Belgium

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

27. mars 2026

Primær fullføring (Antatt)

30. desember 2026

Studiet fullført (Antatt)

31. juli 2027

Datoer for studieregistrering

Først innsendt

8. desember 2025

Først innsendt som oppfylte QC-kriteriene

23. desember 2025

Først lagt ut (Faktiske)

5. januar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2025-416

Plan for individuelle deltakerdata (IPD)

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NEI

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Nei

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Nei

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