Eccentric Cycling : a New Training Modality in Multiple Sclerosis Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maximal Isometric Force
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •One or more contraindications to physical activity
- •Significant comorbidities
- •Current hospitalization or undergoing changes in medication
- •Active flare-up
研究组 & 干预措施
Eccentric group
干预措施: Eccentric training (Other)
Concentric group
干预措施: Concentric training (Other)
结局指标
主要结局
Maximal Isometric Force
时间窗: 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
时间窗: 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.
次要结局
- 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))
研究者
Vandenbroeck Benoit
Physiotherapist
University of Liege