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临床试验/NCT02938000
NCT02938000已完成不适用

E-Rehabilitation: Aerobic Resistance Training for Stroke Survivors

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2016年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
2
主要终点
VO2: aerobic capacity measurement with peak VO2 using 6 minute walk test

研究概览

简要总结

This pilot study intends to evaluate an online exercise video rehabilitation program for stroke survivors with moderate disability compared to usual care. The intervention videos combine aerobic and resistance training using a latex resistance band, Thera band® elastic band, specifically designed for rehabilitation. This study will aim to show that for patients suffering acute ischemic stroke resulting in disability, at-home physical therapy with aerobic exercise videos will improve depression level and aerobic capacity more than usual care.

详细描述

Seven million Americans are stroke survivors and another four million Americans are expected to have strokes by 2030.1 Nearly 800,000 strokes occur annually and of these, 25% occur after a previous stroke or transient ischemic attack (TIA).2 Put another way, stroke recurrence affects 30% of stroke survivors.3 Given the high burden of stroke among stroke survivors, preventing recurrence is a top priority for post-stroke and post-TIA management.

Stroke survivors must cope with impairments in functioning that can range from facial droops to hemiparesis and aphasia. These physical challenges mean that even four years after stroke, 71% of survivors feel they have not completely recovered from the stroke.4 The peak oxygen cost (VO2) of participating in activities of daily living such as walking is higher in stroke survivors six months after stroke than able-bodied individuals.5,6 This increased energy cost is related to decreased cardiorespiratory reserve, changes in tissue composition, and gait deviation and asymmetry.5,6 The exhaustion point for hemiparetic stroke survivors falls within the range of aerobic fitness required to perform activities of daily living (3-5 METS [Metabolic Equivalents]).6 Small increases in aerobic capacity would therefore translate into the ability to perform activities of daily living.6

The American Heart Association (AHA) and American Stroke Association issued guidelines in 2014 recommending physical activity and exercise to improve stroke survivors' functional ability, quality of life, and morbidity of stroke recurrence.3 It is the goal of this study to improve physical activity adherence in stroke survivors and thereby improve their cardiorespiratory reserve and reduce depression. Secondary variables to be examined include functional ability, balance, blood pressure, body mass index (BMI), rates of cerebrovascular and cardiovascular events, and mortality.

Exercise-based cardiac rehabilitation post-stroke or post-TIA Cardiac rehabilitation care post-discharge for stroke survivors is not established standard of practice. Several groups have been evaluating the efficacy of comprehensive cardiac rehabilitation, as provided to patients after acute MI, in post-stroke populations. This intervention has been shown to be cost effective in post-MI care, reducing healthcare cost overall (attributed to fewer re-admissions) and per quality-adjusted life year.12 Several groups have conducted small-scale trials of cardiac rehabilitation among TIA and stroke patients with promising improvements in cardiovascular fitness outcomes.13-16 Aerobic exercise for rehabilitation after stroke has been evaluated in small randomized controlled trials.6,17

One group conducted a randomized controlled trial of a comprehensive cardiac rehabilitation program in chronic stroke patients after ischemic events.14 Their intervention was twice weekly, supervised exercise on cycle ergometers (upper or lower body) to 50-60% maximal heart rate.14 At the end of the ten-week program, subjects in the intervention arm showed significant improvements in cardiovascular fitness as measured by peak oxygen consumption (VO2) and rating of perceived exertion (RPE) after three minutes of exercise.14 Self-reported depression and anxiety scores also improved in the intervention arm, though health-related quality of life did not.14 The same group is now conducting a larger clinical trial called Cardiac Rehabilitation Adapted For Transient Ischemic Attack and Stroke (CRAFTS) expanding on the results of the earlier pilot.13,14

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • acute ischemic stroke within 2 weeks of enrollment

排除标准

  • unstable coronary artery disease, oxygen dependent, with oxygen saturation less than 92% on room air, unable to perform peak oxygen consumption testing, musculoskeletal disease limiting exercise performance.

研究组 & 干预措施

Theraband group

Experimental

This group will be furnished with Thera-band, and link to exercise video, with plans for regular exercise as described previously, in addition to usual post stroke care.

干预措施: Theraband with exercise video (Device)

Usual Care Group

Placebo Comparator

This group will have usual post stroke care, and will be advised to get regular exercise.

干预措施: usual care with advice to exercise (Other)

结局指标

主要结局

VO2: aerobic capacity measurement with peak VO2 using 6 minute walk test

时间窗: 12 weeks

次要结局

  • Berg Balance Score(12 weeks)
  • adherence to exercise program, interventional group only(12 weeks)
  • Patient Health Questionnaire - 9 (PHQ 9)(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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