High-intensity Exercise in Stroke Recovery: Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Change on the Western Aphasia Battery (WAB) - Aphasia Quotient
研究概览
简要总结
The goal of this clinical trial is to evaluate the effects of a high-intensity exercise program on recovery in individuals with post-stroke aphasia. The high-intensity exercise program has been specifically designed for individuals with post-stroke aphasia and includes an interval training full-body workout, which can increase cardiovascular fitness, improve muscle strength and motor performance, and maximize cognitive and language gains. The main question this study aims to answer is:
• Does participation in a high-intensity exercise program lead to changes in physical health, language, cognitive, motor recovery, psychological and/or psychosocial domains?
Participants will be randomly assigned to either a high-intensity exercise program (target intervention) or a low-intensity exercise program (control intervention) delivered over 12-weeks in a group setting.
Outcome measures will be collected once immediately after the intervention period and once during the following 12-week maintenance period to capture short- and long-term effects of the exercise program.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aphasia following ischemic or hemorrhagic stroke
- •Aphasia as determined by a standardized language test (Western Aphasia Battery Aphasia Quotient < 93.8 at study intake)
- •At least 6 months from the last stroke
- •Proficient in English before the stroke
- •At least 8 years of education
- •Between the ages of 18 and 80
- •Independent with ambulation without a device (single-point cane accepted)
- •Medically stable with no contraindications to participate in regular physical exercise as determined by the patients' own primary care provider or other treating provider.
排除标准
- •Prior history of dementia, neurologic illness (other than stroke), or recent (last 3 years) substance abuse
- •Significant visual or hearing disabilities (e.g., neglect, uncorrected visual or hearing loss) that interfere with testing
- •Self-report uncontrolled cardiorespiratory and/or metabolic disorders incompatible with exercise
研究组 & 干预措施
High-intensity physical exercise
The participants will take part in a high-intensity Aphasia Physical EXercise (APEX) intervention designed specifically for individuals with chronic post-stroke aphasia for 12 weeks.
干预措施: High-intensity physical exercise (Behavioral)
Low-intensity physical exercise
The participants will participate in a low-intensity non-aerobic exercise program for 12 weeks.
干预措施: Low-intensity physical exercise (Behavioral)
结局指标
主要结局
Change on the Western Aphasia Battery (WAB) - Aphasia Quotient
时间窗: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
The Aphasia Quotient from the Western Aphasia Battery (a standardized language test) measures overall severity of language impairment in aphasia and ranges from 0 to 100, with lower scores indicative of more severe aphasia.
次要结局
- Change on the WAB subtest scores((T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.)
- Change on the Curtiss-Yamada Comprehensive Language Evaluation - Revised (CYCLE-R)((T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.)
- Changes on Category and Letter Verbal Fluency tasks((T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.)
- Change on the Philadelphia Naming Test (PNT)((T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.)
- Changes on the California Cognitive Assessment Battery (CCAB)((T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.)
- Changes in Maximal Aerobic Capacity((T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention.)
- Change on the 2-minute Step Test((T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.)
- Change on the 30-second chair stands((T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.)
- Change on the Timed Up-and-Go Test((T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.)
- Change on the Functional Reach Test((T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.)
- Change in Gait Speed((T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.)
研究者
Maria Ivanova
Associate Professional Researcher
University of California, Berkeley