Cycle Exercise in Wheelchair Users With Muscular Dystrophy or Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Questionnaire on fatigue
研究概览
简要总结
Wheelchair bound patients often have pain in lower back and glutes, constipation and reduced quality of life - symptoms that exercise might ameliorate. However, in wheelchair bound patients with muscular dystrophies and cerebral palsy only very little research is done on exercise. We thus wish to investigate effects of cycle exercise in wheelchair bound patients with muscular dystrophy and cerebral palsy.
详细描述
Wheelchair bound patients with MD or CP live a sedentary life, and probably because of this, many experience pain in lower back and glutes, obstipation, reduced quality of life, reduced activity of daily living and social withdrawal. Exercise is likely to reduce these symptoms. However, research in exercising patients confined to a wheelchair lacks 3 things: 1) Most research is done in patients that are wheelchair bound due to stroke, and these results are not necessarily transferable to patients with MD or CP. Patients with stroke differ from patients with MD and CP since they can potentially gain walking ability again, they have had walking ability up to the stroke, they are only hemiparetic and thus have normal function in the rest of the body, their muscles are atrophic but otherwise healthy and they have no contractures. 2) Most research in exercise in patients with MD or CP focuses on preventing patients from being wheelchair bound - only very little research is done in the most severely affected patients that are wheelchair bound, although many of their symptoms can potentially be ameliorated by exercise. 3) To date, research in exercise in wheelchair bound patients with MD or CP has primarily consisted of arm cycling. It has been shown to reduce BMI and improve cardiorespiratory status, endurance, muscle strength and activities of daily living, but not without complications. The upper limbs consist of small muscle groups that are easily fatigued and therefore proper cardiopulmonary fitness is difficult to obtain. The risk of upper limb overuse injuries is high, reducing patients function and activities of daily living. Presently, there is no feasible and acceptable way to exercise for this large patient group.
The investigators have tested a cycle ergometer for the lower limbs that can be used while the patients sit in their own wheelchair. It has a motor, since most patients are not able to turn the pedals themselves, and a sensor that can measure how much patients contribute to cycling. They have tested 3 wheelchair bound patients. After training, they all experienced reduced pain in lower back and glutes, less obstipation and increased energy. Surprisingly, the heart rate increased during exercise by up to 65 beats even in patients that could not turn the pedals themselves, indicating cardiovascular fitness. To test this form of exercise in a larger group of patients that are wheelchair bound due to MD or CP will be of great interest.
The aim of this project is thus:
- to test a cycle ergometer for lower limbs in patients who are wheelchair bound due to MD or CP to find a feasible and acceptable way to exercise in order to increase health and quality of life.
- to investigate if patients unable to move their legs will have effect of the training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statistics will be made by an investigator blinded to what results are from before, in-between and after the two periods of rest and exercise respectively.
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
- •Verified muscular dystrophy or cerebral palsy
- •Age: Over 18 years
- •Wheelchair use; can at maximum stand up for transfers and is unable to walk for more than 5 meters.
排除标准
- •Competing disorders (as arthritis) or other muscle disorders
- •Unable to use the cycle ergometer due to contractures
研究组 & 干预措施
Run-in period, patients with cerebral palsy or muscular dystrophy
10 weeks of no exercise
Exercise period, patients with cerebral palsy or muscular dystrophy
10 weeks of exercise
干预措施: Cycle exercise (Other)
结局指标
主要结局
Questionnaire on fatigue
时间窗: 5 minutes
The FSS (fatigue severity scale) will be used. Scores range from 1 to 7 with a total maximum score at 63. Lower scores mean less fatigue.
Questionnaire on pain.
时间窗: 5 minutes
A visual pain score that has been used in former studies with 3 questions with scores ranging from 1 to 10 each, 10 being the worst pain imaginable, will be used.
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 quality of life, QOL
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.
次要结局
- Blood sample(5 minutes)
- Ultrasound(20 minutes)
- Motorscore(30 minutes)
- Exercise test(30 minutes)
研究者
Nanna Scharff Poulsen
MD, PhD-student
Rigshospitalet, Denmark
