The Effects of Aerobic Exercise on Sleep Quality, Quality of Life, and Functional Status in Stroke Patients Treated With Botulinum Toxin for Upper Extremity Spasticity
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bursa Yuksek Ihtisas Training and Research Hospital
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Functional Recovery, Sleep, and Quality of Life Outcomes
概览
简要总结
This study aimed to investigate the contribution of aerobic exercise programmes to improving sleep quality, quality of life, and functional status, alongside conventional rehabilitation, in stroke patients who had received botulinum toxin treatment for upper extremity spasticity.
详细描述
This randomized controlled trial included 62 chronic stroke patients receiving BTX-A injections for upper extremity spasticity. Participants were randomized into two groups: one that participated in a 4-week aerobic exercise program and a control group that received conventional rehabilitation without aerobic exercise. The primary outcomes were functional independence, upper extremity motor development, walking speed, sleep quality and quality of life.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Weeks 至 75 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •62 patients aged 18-75 years who were planned for botulinum toxin treatment due to upper extremity spasticity following a stroke
排除标准
- •Stroke patients who had BTX-A injections for lower extremity spasticity or had a Modified Ashworth Scale (MASH) score ≥ 2 for lower extremity spasticity,
- •Uncontrolled diabetes, hypertension, cardiovascular diseases,
- •Cognitive dysfunction,
- •Flaccid stroke,
- •Upper extremity disorders (fractures, frozen shoulder, arthritis, surgery),
- •Pre-existing sleep disorders (obstructive sleep apnea, insomnia, parasomnia, narcolepsy, restless leg syndrome, or psychiatric disorders),
- •Cancer diagnosis,
- •Those who had received antispastic or antiepileptic treatment with dose changes in the last month
研究组 & 干预措施
Aerobic Exercise Group
Participants in this group received a supervised low- to moderate-intensity aerobic exercise program in addition to standard care. The aerobic exercise program was performed three times per week for four weeks, with 30-minute sessions consisting of warm-up, exercise, and cool-down periods. All participants also received botulinum toxin type A injections and conventional rehabilitation as part of routine clinical care.
干预措施: Aerobic exercise training using a cycle ergometer (Other)
Control Group
Participants in this group received standard care only, consisting of botulinum toxin type A injections for upper extremity spasticity and conventional rehabilitation.
结局指标
主要结局
Functional Recovery, Sleep, and Quality of Life Outcomes
时间窗: From baseline to 12 weeks after starting the exercise program
Health-related quality of life will be assessed using the Euroqol Quality of Life Scale, which evaluates mobility, selfcare, usual activities, pain and depression, with higher index values indicating better quality of life. Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (0-24), where higher scores indicate greater sleepiness. Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (0-21), with higher scores indicating poorer sleep quality. Activities of daily living will be assessed using the Barthel Index (0-20). Functional independence will be evaluated using the Functional Independence Measure (18-126), with higher scores indicating greater independence. Neurological and motor recovery will be assessed using Brunnstrom stages, upper extremity motor function using the Fugl-Meyer Assessment of the Upper Extremity (0-66) and spasticity using the Modified Ashworth Scale. Functional exercise capacity will be assessed using the 6-Minute Walk Test.
Effects of Aerobic Exercise on Sleep Quality, Quality of Life, and Functional Status in Stroke Patients Treated with BTX-A for Upper Extremity Spasticity
时间窗: From baseline to 12 weeks after starting the exercise program
次要结局
未报告次要终点
研究者
Merve Yeni
Doctor, Department of Physical Medicine and Rehabilitation
Bursa Yuksek Ihtisas Training and Research Hospital