Aerobic Exercise Training in Acute Ischaemic Stroke: A Single-centre, Single-blinded, Randomised, Controlled Feasibility Study of an Aerobic Exercise Training Intervention Versus Standard Care Conducted in the Acute Phase of Stroke.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety of aerobic exercise training
研究概览
简要总结
Stroke is a leading cause of adult disability in the UK. There are few treatment options that improve long-term disability outcomes after stroke. Animal studies indicate that aerobic exercise training can improve brain repair and reduce disability after stroke. However, in clinical practice it is difficult for stroke survivors to undertake aerobic exercise due to lower-limb disability and a lack of accessible exercise equipment. This study will assess the feasibility of implementing a 5-day aerobic exercise training intervention, beginning in the acute phase of stroke (1-7 days post-stroke), using a power-assisted exercise bike. Feasibility outcome measures: recruitment rate (30 participants recruited within 18 months), completeness of data (>80% of planned measurements recorded) and the safety (<10 adverse events related to the intervention) and acceptability (>3/5 comfort scale) of the intervention. We will also investigate the acute effects of aerobic exercise on cerebral blood flow velocity using transcranial Doppler ultrasound, and brain-derived neurotrophic factor (serum and plasma).
详细描述
Introduction
Pre-clinical studies indicate that aerobic exercise training can enhance brain repair and reduce disability when initiated early (1-7 days) after stroke. However, in the real-world clinical setting, most acute stroke patients have a lower-limb disability which makes it difficult to engage in aerobic exercise. Power-assisted exercise bikes can detect lower-limb motor deficits and compensate with motorised assistance. The primary aim of this study is to assess the feasibility of implementing a 5-day power-assisted aerobic exercise training programme, initiated in the acute phase of ischaemic stroke (1-7 days post-stroke). Key feasibility outcomes related to the intervention include safety (<10 adverse events related to the intervention) and acceptability (>3/5 comfort scale). The secondary aim is to assess the feasibility of conducting a randomised controlled trial (RCT), with a focus on study procedures including recruitment (30 participants recruited within 18 months) and completeness of data (≥80% of planned measurements recorded), and identification of a suitable primary outcome measure for a large-scale RCT.
Recruitment
People with acute ischaemic stroke admitted to the Royal Hallamshire Hospital (Sheffield, England) will be recruited to this study. After eligible individuals provide informed consent, a web-based permuted block randomisation procedure will be used to allocate participants into one of two study arms: 1) usual care; or 2) aerobic exercise training plus usual care. Participants will be stratified using the National Institutes of Health Stroke Scale (NIHSS): mild to moderate (0-15) and moderate to severe (>15) measured after reperfusion therapy or at a similar timepoint if not eligible for reperfusion therapy. Accounting for a predicted attrition rate of 20%, the target sample size is 30 participants.
Intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Adult (age >18 years) patients diagnosed with acute ischaemic stroke 1-7 days previously.
- •Medically stable, assessed by a stroke physician.
- •Sufficient English language comprehension and cognitive ability to understand the study protocol, follow instructions, complete questionnaires and give informed consent.
- •Ability to mobilise lower body limbs in a cyclical manner (at least one leg).
- •Likely to be admitted to the Royal Hallamshire Hospital for at least 7 days.
排除标准
- •Haemorrhagic stroke.
- •<1 day or >7 days after onset of stroke symptoms.
- •Clinically unstable, assessed by stroke physician.
- •Disability preventing unipedal cycling.
- •New York Heart Failure Classification stage III/IV.
- •Terminal illness (life expectancy <6 months).
- •Resting blood pressure >180/110 mmHg.
- •Uncontrolled arrhythmia causing symptoms or haemodynamic compromise.
- •Unstable angina.
- •Uncontrolled diabetes mellitus.
- •Acute deep vein thrombosis, pulmonary embolism or pulmonary infection.
- •Already participating in a clinical research trial.
- •Pain during mobilisation of lower-limbs.
- •Lower-limb spasticity or contracture which impairs ability to cycle.
结局指标
主要结局
Safety of aerobic exercise training
时间窗: 21 months
The following traffic light-style system is proposed: * Red: \>10 adverse events related to the intervention - do not proceed. * Amber: 5-10 adverse events related to the intervention - review and revise protocol. * Green: \<5 adverse events related to the intervention - proceed.
Acceptability of aerobic exercise training
时间窗: 18 months
Average comfort score \> 3/5 Likert scale (1= very uncomfortable to 5= very comfortable)
次要结局
- Feasibility of recruitment(18 months)
- Feasibility of data collection(21 months)
研究者
Simon Nichols
Senior Research Fellow
Sheffield Hallam University