Eccentric Cycling : a New Training Modality in Multiple Sclerosis Rehabilitation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Liege
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Maximal Isometric Force
Study Overview
Brief 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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Eccentric group
Intervention: Eccentric training (Other)
Concentric group
Intervention: Concentric training (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Neurocognitive capacity(At baseline and endline of intervention (Week 1 and 14))
- Handgrip strength(At baseline and endline of intervention (Week 1 and 14))
- Spasticity(At baseline and endline of intervention (Week 1 and 14))
- Timed up and go(At baseline and endline of intervention (Week 1 and 14))
- Five time sit to stand test(At baseline and endline of intervention (Week 1 and 14))
- Berg Balance Scale(At baseline and endline of intervention (Week 1 and 14))
- Maximal aerobic power(At baseline and endline of intervention (Week 1 and 14))
- Maximal oxygen consumption(At baseline and endline of intervention (Week 1 and 14))
- Fatigue(At baseline and endline of intervention (Week 1 and 14))
- Multiple Sclerosis Quality of Life-54(At baseline and endline of intervention (Week 1 and 14))
- Maximal heart rate(At baseline and endline of intervention (Week 1 and 14))
Investigators
Vandenbroeck Benoit
Physiotherapist
University of Liege