The Effect of Cycling Using Active-passive Trainers on Spasticity, Cardiovascular Fitness, Function and Quality of Life in People With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Effect of spasticity on daily life scored on Multiple Sclerosis Spasticity Scale (MSSS-88)
研究概览
简要总结
This randomised controlled trial aims to explore the effectiveness of a four week programme of exercise using lower limb Active Passive trainer (APT) (MOTOmed trainer) in terms of spasticity in people with moderate to severe Multiple Sclerosis.
详细描述
Exercise is beneficial for people with Multiple Sclerosis (pwMS). However, exercise options for those with moderate to high levels of disability are limited. Cycling, delivered with an Active Passive Trainer (APT) is one exercise option often offered within rehabilitation/exercise settings and many pwMS buy APTs for home use. Anecdotally, pwMS report they feel better and their spasticity reduces after APT cycling, however there is a lack of evidence to support this.
30 pwMS will be recruited from the Physical Disability Rehabilitation Unit at the Queen Elizabeth University Hospital, Glasgow, and randomised to APT + usual care or usual care only. Those in the APT group will receive 30 minutes of APT (2 mins passive warm up, 26 mins active cycling and 2 mins passive cool down), five days per week for 4 weeks. Outcome measures will be cardiovascular fitness measured using the oxygen uptake efficiency slope (OUES), spasticity assessed by Modified Ashworth Scale (MAS) and the Multiple Sclerosis Spasticity Scale (MSSS-88), function assessed by the Functional Independence Measure (FIM) and the Timed 25 foot walk test (T25FW), Quality of Life measured by MSQOL-54. Outcome measures will be assessed in both groups before and after the 4 week intervention period. Symmetry, distance cycled and power will be recorded following each cycling session in the intervention group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have a confirmed diagnosis of progressive MS
- •are aged over 18 years
- •have an Expanded Disability Status Scale (EDSS) of between 6.5 (requires two walking aids - pair of canes, crutches, etc - to walk about 20m without resting) and 8.5 (essentially restricted to bed much of day); has some effective use of arms (retains some self care functions) and spasticity in their lower limbs (self reported)
排除标准
- •cognitive impairment (cannot understand instructions)
- •other co-morbidities which would preclude them taking part in exercise
- •visual impairment (such that they cannot see the screen on the APT)
研究组 & 干预措施
Intervention group
Usual care - conventional, personalised in-patient rehabilitation - plus APT cycling programme 4 weeks duration
干预措施: Usual care (Other)
Control group
Usual care - conventional, personalised in-patient rehabilitation 4 weeks duration
干预措施: Usual care (Other)
Intervention group
Usual care - conventional, personalised in-patient rehabilitation - plus APT cycling programme 4 weeks duration
干预措施: APT (Other)
结局指标
主要结局
Effect of spasticity on daily life scored on Multiple Sclerosis Spasticity Scale (MSSS-88)
时间窗: Change from Baseline at 4 weeks
Score on Multiple Sclerosis Spasticity Scale (MSSS-88)
次要结局
- Spasticity scored on Modified Ashworth Scale (MAS)(Change from Baseline at 4 weeks)
- Cardiovascular fitness calculated using Oxygen Uptake Efficiency Slope (OUES)(Change from Baseline at 4 weeks)
- Function - FIM(Change from Baseline at 4 weeks)
- Function - T25FW(Change from Baseline at 4 weeks)
- Quality of Life (MSQOL)-54 scale(Change from Baseline at 4 weeks)
- APT cycling performance - symmetry(Change from Baseline at 4 weeks)
- APT cycling performance - distance(Change from Baseline at 4 weeks)
- APT cycling performance - power(Change from Baseline at 4 weeks)