- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07316764
Eccentric Cycling in Multiple Sclerosis Rehabilitation
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.
Study Overview
Status
Intervention / Treatment
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.
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.
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. 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 (see appendix):
Phase 0: Baseline Testing
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.
Eccentric Ergocycle Training Protocol Phase 1: Familiarization (4 weeks)
Two sessions per week for four 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)
These four weeks establish the first phase of training, with predefined duration and intensity levels.
Phase 3: Training (Part 2 - 4 weeks)
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.
Throughout the 12-week training period, temporal progression and identification of potential physiological adaptations will be monitored.
Phase 4: Final Testing
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Benoît Vandenbroeck, PhD Student
- Phone Number: +32474271843
- Email: benoit.vandenbroeck@uliege.be
Study Locations
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-
Liège
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Liège, Liège, Belgium, 4000
- Liege University
-
Contact:
- Benoît Vandenbroeck, PhD Student
- Phone Number: +32474271843
- Email: benoit.vandenbroeck@uliege.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
- Current hospitalization or undergoing changes in medication
- Active flare-up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Eccentric group
|
Eccentric cycling training
|
|
Active Comparator: Concentric group
|
Concentric cycling training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At baseline and endline of intervention (Week 1 and 14)
|
|
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.
|
At baseline and endline of intervention (Week 1 and 14)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Handgrip strength
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Height
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Stéphanie HODY, PhD, Department of Physical Activity and Rehabilitation Sciences, University of Liege and University Hospital of Liege, Liege, Belgium
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-416
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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