NCT06268041招募中不适用
Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke: HIT-Stroke Trial 2
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 6
- 主要终点
- 6-Minute Walk Test Distance
研究概览
简要总结
People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at 3-month follow up (3moPOST), by raters who are unaware of the participant randomization.
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
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-85 years at time of consenting
- •Hemiparesis from ischemic and/or hemorrhagic strokes
- •Most recent stroke for which participant sought treatment, at least 6 months prior to study consent
- •Walking speed <1.0 m/s on the 10-meter walk test
- •Able to walk 10m over ground with assistive devices as needed and no continuous physical assistance from another person (guarding and intermittent assistance for loss of balance allowed)
- •Able to walk at least 3 minutes on the treadmill at ≥0.13m/s (0.3 mph)
- •Stable cardiovascular condition (AHA class B, allowing for aerobic capacity <6 metabolic equivalents)
- •Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions
排除标准
- •Exercise testing uninterpretable for ischemia or arrhythmia (e.g. resting ECG abnormality that makes exercise ECG uninterpretable for ischemia and no other clinical testing from the past year available to rule out these conditions)
- •Evidence of significant arrhythmia or myocardial ischemia on treadmill ECG graded exercise test in the absence of recent (past year) more definitive clinical testing (e.g. stress nuclear imaging) with negative result
- •Hospitalization for cardiac or pulmonary disease within past 3 months
- •Implanted pacemaker or defibrillator with an upper heart rate limit that would interfere with exercise testing or prescription, or with unknown limit
- •Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
- •Severe lower limb spasticity (Ashworth >2)
- •Known recent history (<3 months) of unstable substance abuse or unstable mental illness
- •Major post-stroke depression (Patient Health Questionnaire [PHQ-9] ≥ 10) in the absence of depression management by a health care provider
- •Currently participating in physical therapy or another interventional study targeting walking function
- •Recent (<2 weeks) or planned changes in lower limb orthotic or spasticity management
- •Foot drop or lower limb joint instability without adequate stabilizing device, as assessed by a physical therapist
- •Clinically significant neurologic disorder other than stroke or unable to walk outside the home prior to stroke
- •Unable to walk outside the home prior to stroke
- •Other significant medical condition likely to limit improvement or jeopardize safety as assessed by a physical therapist (e.g. joint contracture, gait limited by pain)
- •Pregnancy
- •Previous exposure to fast treadmill walking (>3 cumulative hours) in the past year
研究组 & 干预措施
Moderate-Intensity Aerobic Training
Active Comparator
干预措施: Moderate-Intensity Aerobic Training (Behavioral)
High-Intensity Interval Training
Experimental
干预措施: High-Intensity Interval Training (Behavioral)
结局指标
主要结局
6-Minute Walk Test Distance
时间窗: Change from Baseline to 12 weeks
Total distance walked in 6 minutes in meters
次要结局
- Fastest Gait Speed(Change from Baseline to 12 weeks)
- PROMIS-Fatigue Scale version 8a(Change from Baseline to 3 month follow up)
- 6-Minute Walk Test Distance(Change from Baseline to 3 month follow up)
- Aerobic Capacity(Change from Baseline to 12 weeks)
- Self-Selected Gait Speed(Change from Baseline to 12 weeks)
- EuroQol-5D-5L(Change from Baseline to 3 month follow up)
研究者
Pierce Boyne
Associate Professor
University of Cincinnati
研究点 (6)
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