Does a Cardiorespiratory Interval Training Program at Home Improve Post-stroke Fatigue?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Post-stroke fatigue
研究概览
简要总结
Post-stroke fatigue is common and negatively influences post-stroke recovery. Today, there is insufficient evidence how to treatment post-stroke fatigue. Our objective is to investigate if a structured cardiorespiratory interval training program added to the early supported discharge (ESD)-service results in relieved post-stroke fatigue and increased oxygen uptake.
This is a 1:1 prospective randomized open- label trial(Two-centre study) with blinded evaluators (PROBE-design) of 50 participants referred to ESD with study start at 4 (±1) weeks after discharge from the stroke unit. The intervention group (N=25) receives a structured cardiorespiratory interval training program on ergometer cycle, 30-40 minutes, 3 days a week for 8 weeks. The cardiorespiratory interval training program comprises of 4x4 minute interval, at 70 to 80% of peak heart rate, interrupted by 3 minutes active recovery.
The control group (N=25) receives usual ESD care. The primary outcome will be a shift in the Swedish Fatigue Assessment Scale before intervention (baseline) versus 8 weeks months after start of intervention in the intervention and control groups. Secondary outcomes include cardiorespiratory fitness, compliance, adherence and adverse events.
详细描述
Stroke is a major cause of disability among adults. After stroke, post-stroke fatigue is a common and negatively influences post-stroke recovery. Today, there is insufficient evidence how to treatment post-stroke fatigue. Post-stroke fatigue is considered to have a multifactorial cause and it is biologically plausible that fatigue might be related to physical deconditioning and reduced physical activity.
After stroke, functional limitations often lead to a reduction in physical activity, which in turn may lead to decline in cardiorespiratory fitness. Cardiorespiratory fitness is often measured as peak oxygen consumption, VO2peak. Studies have reported that physical activity and cardiorespiratory fitness is lower in stroke victims than gender- and aged-matched healthy individuals.
Intervention aimed to increased cardiorespiratory fitness has been highlighted as an important component in in stroke rehabilitation. Guidelines for physical activity and cardiorespiratory fitness following stroke recommend cardiorespiratory training 20-60 minutes, 3-7 days a week at 50-80% of maximal heart rate. Interval training (4 x 4 minutes) has showed to improve cardiovascular fitness at different patient groups, including Stroke.
Today, stroke unit and early supported discharge service (ESD) is recommended as an effective way to improve patient outcome and quality of care following stroke. The ESD service provides support and rehabilitation for the patients in their own environment and the rehabilitation is often focused on activities in daily living and mobility.
The objective of this study is to investigate if a structured cardiorespiratory interval training program added to the early supported discharge (ESD)-service results in relieved post-stroke fatigue and increased oxygen uptake. Furthermore, the study will explore whether it is feasible and safe for patients with post-stroke fatigue to perform a structured cardiorespiratory interval training program in their home environment.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preliminary or final diagnosis of acute stroke due to Brain infarction: large vessel disease, lacunar syndrome, cryptogenic stroke Intracerebral hemorrhage
- •Post-stroke fatigue (defined as a summation score of 28 or more on the S-FAS)
- •Medical stability
- •Independent living in Umeå or Gävle (in the nearby surrounding areas) and able to cycle an ergometer cycle.
排除标准
- •Patients with severe stroke with modified Rankin Scale >3
- •Atrial fibrillation, pacemaker or other arrhythmia which exclude reliable monitoring of heart-frequency
- •Unstable pulmonary or cardiac disease
- •Serious co-morbidity with for example terminal cancer, hemodialysis, severe cognitive dysfunction with Montreal Cognitive Assessment (MOCA) ≤ 26
- •Drug abuse
- •Patients living far away from the hospital or in residential care facilities.
结局指标
主要结局
Post-stroke fatigue
时间窗: The S-FAS will be measured before intervention (pre-treatment test) and immediately after end of 8 week intervention (post-treatment test)
Post-stroke fatigue will be measured with The Swedish Fatigue Assessment Scale (S-FAS) comprises 10 questions that describe how a person generally feels. The answers are given using a 5-point scale ranging from 1 (never) to 5 (always) such that the total score ranges from 10 to 50 points. Items 4 and 10 require reversed scoring. A high score indicate an increase level of fatigue.
次要结局
- Feasibility (Adherence)(Adherence will be measured throughout the intervention and will be monitored at each individual training session, 3 days a week for 8 weeks)
- Cardiorespiratory fitness (Peak oxygen consumption, VO2peak)(Cardiorespiratory fitness (peak oxygen consumption) will be measured before intervention (pre-treatment test) and immediately after end of 8 week intervention (post-treatment test))
- Feasibility (Fidelity)(Fidelity will be measured throughout the intervention and will be monitored at each individual training session, 3 days a week for 8 weeks)
- Feasibility (Adverse events)(Adverse events will be measured throughout the intervention and will be monitored at each individual training session, 3 days a week for 8 weeks)