High-intensity Interval Training in Patients With Spinal Muscular Atrophy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Questionnaire on quality of life
研究概览
简要总结
Patients with spinal muscular atrophy who are wheelchair users often experience lower back - and gluteal pain, reduced sleep quality, constipation and reduced quality of life - symptoms that regular exercise could potentially alleviate. However, only very little research has been done on exercise for patients who are wheelchair users. The aim of this study is to explore the impact of cycle exercise on patients with spinal muscular atrophy.
详细描述
Spinal muscular atrophy (SMA) is a neuromuscular disease affecting the motor neurons of the spinal cord that innervate the skeletal muscles, leading to progressive muscle atrophy and weakness. Consequently, many patients end up having to use a wheelchair from an early age.
Besides the impaired motor function, patients with SMA can also experience a variety of symptoms associated with their disease, a sedentary lifestyle and physical inactivity such as lower back and leg pain, obstipation, reduced sleep quality and impacted quality of life.
Training can help alleviate these symptoms in patients with neuromuscular diseases. However, there isn´t any validated way for patients with SMA to train as of today.
Research has shown that high-intensity interval training (HIIT) has been well tolerated among patients with SBMA, a disease resembling SMA with patients tolerating this form for training well.
The aim of this study is to investigate:(1) if HIIT could be exercise modality in SMA patients (2) and to see what positive effects exercise has for their impaired motor function and related challenges.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal muscular atrophy
- •Age: over 15 years
排除标准
- •Competing disorders (as arthritis) or other muscle disorders as well as heart- or lung related issues.
- •Current psychiatric treatment
- •Unable to use the cycle ergometer due to contractures
结局指标
主要结局
Questionnaire on quality of life
时间窗: 10 minutes
A QoL that has been used in former studies will be used. 16 questions with scores ranging from 1 (very unsatisfied) to 7 (very satisfied) will be scored.
Questionnaire on constipation
时间窗: 5 minutes
A questionnaire made from the Danish definition of constipation will be used. Four questions will be answered "yes" or "no".
Questionnaire on pain.
时间窗: 5 minutes
A visual pain score for leg and lower back pain with 3 questions with scores ranging from 1 to 10 each, 10 being the worst pain imaginable, will be used.
Questionnaire on fatigue
时间窗: 5 minutes
The Multidimensional Fatigue Inventory (MFI-20) will be used. It measures fatigue in 5 different domains comprised of 4 items each with values ranging from 1 to 5. A higher score indicates more fatigue. Each domain is scored individually, ranging from 4 points (best outcome) to 20 points (worst outcome).
Questionnaire on sleep quality
时间窗: 10 minutes
Minimum Score = 0 (better); Maximum Score = 21 (worse) Interpretation: TOTAL \< 5 associated with good sleep quality TOTAL \> 5 associated with poor sleep quality Minimum Score = 0 (better); Maximum Score = 21 (worse) Interpretation: TOTAL \< 5 associated with good sleep quality TOTAL \> 5 associated with poor sleep quality Minimum score is 0, maximum score is 21. Total over 5 is associated with good sleep quality and under 5 associated with poor sleep quality.
次要结局
- Ultrasound scan(15 minutes)
- Motorscore(20 minutes)
- MRI scan liver size(5 minutes)
- Exercise test(7 minutes)
- MR-elastography(5 minutes)
- MRI scan liver steatosis(5 minutes)
- Blood sample(2 minutes)
- MRI scan(15 minutes)
研究者
John Vissing
Prof. MD.
Rigshospitalet, Denmark