The Effect of Low-İntensity Combined Exercises on Fatigue, Balance and Quality of Life in Patients With Early Stage ALS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The fatigue severity scale (FSS)
研究概览
简要总结
The aim of this study is to investigate the effects of low-intensity combined exercises on balance, fatigue and quality of life applied to patients with ALS.
详细描述
Balance problems and signs of fatigue are seen in early-stage ALS patients. While balance problems lead to falls in ALS patients, fatigue also affects a part of their lives. Studies investigating the effects of low-intensity exercise on fatigue, balance, and quality of life in patients with early-stage ALS are rare. This study will investigate the effects of low-intensity combined exercises on balance, fatigue and quality of life in patients with ALS.
Participants will be randomly divided into Supervised and Home groups. Low-intensity exercises will be applied to the home exercise group as a home program for 1 hour a day, 3 days a week, for 6 weeks. Low-intensity exercises will be applied to the supervised exercise group for 1 hour a day, 3 days a week for 6 weeks, accompanied by a physiotherapist. Evaluations will be made at the beginning and at the end of the treatment.
Berg Balance Scale, Fatigue Severity Scale (FSS), Amyotrophic Lateral Sclerosis Assessment Questionnaire-40 (ALSAQ-40) and revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) will be used to evaluate patients before and 6 weeks after treatment.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed with early-stage ALS by a neurologist
- •Disease duration in the range of 1-18 months
- •ALSFRS-R score > 24 higher
- •Without infectious disease
- •Saturation >95
- •Heart rate <92
排除标准
- •History of other neurological disease
- •Inability to walk
- •With mechanical ventilation
- •People with Heart and Respiratory Insufficiency
- •People with neuropsychological or cognitive impairment
- •Dyspnea after ALS
结局指标
主要结局
The fatigue severity scale (FSS)
时间窗: Post-intervention (7th week)
FSS is a self-report scale of nine items examining motivation, physical function, responsibilities, work, family or social life, exercise, fatigue, frequency of problems, and priority of symptoms.
次要结局
- Berg Balance Scale (BBS)(Post-intervention (7th week))
- Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40)(Post-intervention (7th week))
- ALS Functional Rating Scale Revised (ALSFRS-R)(Post-intervention (7th week))
研究者
Xhennet Muriqi
Researcher
Istanbul University - Cerrahpasa (IUC)