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临床试验/NCT05429255
NCT05429255已完成不适用

Aerobic Training vs Exergame Training in Patients With Chronic Mild-Moderate Stroke

Columbia University2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年6月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Average Gait Speed

研究概览

简要总结

The purpose of this study is to compare aerobic training to exergame training in people with chronic mild/moderate stroke. The objectives of this study are two-fold: 1) To evaluate the effects of a home-based aerobic exercise cycle ergometer program on cardiorespiratory fitness, mobility, cognitive, and exercise self-efficacy outcomes in subacute and chronic stroke patients; and 2) to evaluate the effects of an exergaming program on the same outcomes.

详细描述

Annually, 13.7 million strokes occur worldwide, placing it as a leading cause of death and disability, especially among older adults. Stroke survivors often face significant cognitive and motor impairments for months to years after a stroke event, creating significant deficits in functional capacity during activities of daily living (ADLs), as well as in overall quality of life. Stroke patients have identified interventions to improve cognitive outcomes, mobility training, and exercise programs as top priorities for guiding research pursuits.

Aerobic exercise has been shown to produce significant improvements in key stroke rehabilitation outcomes, including functional movement, balance and cardiorespiratory fitness. Exercise programs have been shown to improve a variety of functional outcomes important for carrying out ADLs, including gait speed, gait endurance, Berg Balance Score, and 3-meter Timed Up and Go. Additionally, there is mounting evidence that aerobic exercise may improve cognitive recovery post-stroke. However, the research showing these effects has largely focused on exercise programs incorporated in a hospital or rehabilitation facility where patients are actively supervised by rehabilitation specialists. The American Heart Association recognizes that long-term and widely-applicable solutions for increasing exercise in post-stroke populations must hold the goal of exercise independence in the home and community settings.

Cycle ergometry, commonly known as an exercise bike, is a staple for stroke rehabilitation programs given its minimal fall risk and ability to produce moderate to vigorous intensity physical activity in participants. Exercise programs using cycle ergometry have been shown to produce all previously mentioned functional and cardiorespiratory improvements in stroke survivors, however, the translation of this effectiveness to the home-environment is unknown. Additionally, cycle ergometry may have smaller effects on functional mobility outcomes than walking interventions, forcing prescribing physicians and patients to choose between long-term improvement and reduced fall risk. One potential alternative or supplement to traditional aerobic exercise programs is exergaming, interventions which use physically active video games to engage participants in exercise. Exergames have been shown to be safe and produce moderate intensity physical activity levels in subacute and chronic stroke patients. Additionally, they have been shown to increase a variety of functional outcomes when added to standard post-stroke rehabilitation care, however, like aerobic exercise programs, previous research has focused on the supervised clinical setting, and it is unknown if they produce similar effects to aerobic exercise.

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)

盲法说明

Person performing outcome assessments will not know which group the patient is assigned. Participant cannot be blinded given nature of intervention.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stroke greater than 3 months ago
  • NIH stroke scale score less than 15

排除标准

  • Other neurological impairments
  • Medically unstable
  • Inability to exercise
  • Joint pain
  • Heart failure or other heart arrythmias

结局指标

主要结局

Average Gait Speed

时间窗: baseline and 1 month

Participants will walk as fast as possible on a 9-m runway 3 times, and the results will be averaged.

次要结局

  • VO2max(baseline and 1 month)
  • Berg Balance Scale(baseline and 1 month)
  • Cognition(baseline and 1 month)
  • Timed up and GO(baseline and 1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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