Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke: HIT-Stroke Trial 2

University of Cincinnati6 个研究点分布在 1 个国家目标入组 156 人2024年2月9日

适应症Stroke

干预措施Moderate-Intensity Aerobic Training High-Intensity Interval Training

概览

阶段: 不适用
干预措施: Moderate-Intensity Aerobic Training
疾病 / 适应症: Stroke
发起方: University of Cincinnati
入组人数: 156
试验地点: 6
主要终点: 6-Minute Walk Test Distance
状态: 招募中
最后更新: 昨天

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2024年2月9日

结束日期

2028年4月1日

最后更新

昨天

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

University of Cincinnati

责任方

Principal Investigator

主要研究者

Pierce Boyne

Associate Professor

University of Cincinnati

入排标准

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