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临床试验 NCT05936008 (FAST) 针对中风，缺血性中风，出血性中风目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
堪萨斯大学Fitness After Stroke Trial (FAST)
The long-term goal of this project is to develop and test strategies to be implemented in larger clinical trials to improve health in people living with stroke. For this preliminary efficacy trial, the Investigator will enroll 50 participants with chronic stroke, age 20-85 years, into a 4-week exercise program. Participants will be allocated to one of the following groups using minimization, a type of randomization based on the lower extremity Fugl-Meyer score: 1) moderate intensity continuous training (MICT), that serves as the control, or 2) high-intensity interval training (HIIT). Exercise will be performed on a recumbent stepper. The Investigator will: Assess the preliminary efficacy of HIIT on aerobic fitness (Aim 1), cerebrovascular hemodynamics (Aim 2), and vascular function (Aim 3).
Current exercise recommendations for stroke use general exercise prescription principles for older adults and are not grounded on data generated from large, well-designed, randomized controlled trials in stroke. If aerobic exercise could be proven to reduce the number of "years of life lived with disability," it would offer a key strategy for: 1) minimizing dependence on caregiver support, 2) reducing overall healthcare costs, and 3) extending quality of life for individuals after stroke. This proposed trial will address an important gap in knowledge for both the scientific and clinical communities and provide essential data that will contribute to future exercise prescription recommendations focused on stroke.
Investigating Exercise Prescription Parameters on Aerobic Fitness and Vascular Health After Stroke: A Pilot Study
- FAST
- STUDY00147598
cerebrovascular
cardiovascular
walking
aerobic fitness
brain
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照Moderate intensity, continuous training (MICT) After a 5-minute warm-up at 30% peak watts, MICT will consist of continuous exercise for 25 minutes at 55% of peak watts (range: 45%-65%). The average heart rate for each individual session should not exceed 70% (60-70%) of HR maximum to align with current exercise recommendations for stroke. An active cool-down (20% peak workload) at comfortable stepping pace occurs immediately after the intervention. | Exercise MICT Standard of care, exercise recommendations for people with stroke |
阳性对照High intensity, interval exercise (HIIT) After the 5-minute warm-up at 30% peak watts, HIIT will consist of repeated 1-minute, high intensity bursts ("on" interval) alternated with 1-minute interval recovery ("off" interval) for 25 minutes. The "on" interval will begin at 70% of peak watts (range: 65%-95%) followed by the "off" interval at 10% of peak watts. The average HR for the "on" intervals will not exceed 85% age predicted maximum (75-85%). There will be 13 minutes of "on" and 12 minutes of "off" interval exercise. An active cool-down (20% peak workload) at comfortable stepping pace occurs immediately after the intervention. | Exercise HIIT The HIIT protocol consists of Short Interval, High Volume exercise at 1-minute exercise bouts followed by 1-minute active recovery for 25 minutes. |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Oxygen uptake (VO2) | Assessing change in oxygen uptake during a submaximal exercise test | Baseline, 4 weeks |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Middle cerebral artery velocity | Assessing change in middle cerebral artery velocity response to an acute exercise bout | Baseline, 4 weeks |
Middle cerebral artery velocity at rest | Assessing change in middle cerebral artery velocity during a rest condition | Baseline, 4 weeks |
Flow-mediated Dilation | Endothelial vascular function | Baseline, 4 weeks |
Pulse Wave Velocity | Arterial stiffness | Baseline, 4 weeks |
- Both sexes between the age of 20-85 years at time of consent
- Chronic ischemic or hemorrhagic stroke 6 months to 15 years at consent. People with stroke and newly diagnosed cardiovascular complications had >50% prevalence of recurrent stroke at 5 years. Index stroke or recurrent stroke on same side as index stroke will be allowed.
- Ability to walk over ground with assistive devices and no continuous physical assistance from another person to perform tests for gait speed and six-minute walk test
- Exercise continuously for minimum of 30 watts for 3 minutes on the recumbent stepper to demonstrate ability to perform the exercise test.
- No aerobic exercise contraindications or other safety/physical concerns during the submaximal exercise test.
- Able to communicate with investigators, follow 2-step command & correctly answer consent comprehension questions
- Currently participating in less than 150 minutes of physical activity/week assessed by the Rapid Assessment of Physical Activity
- Stable blood pressure & statin medication doses for 30 days prior to enrollment due to effects on vascular health/hemodynamics
- Hospitalization for cardiac or pulmonary disease within past 3 months
- Implanted pacemaker or defibrillator limiting exercise performance
- Reported pain that limits or interferes with activities of daily living and physical activity/exercise
- Severe LE spasticity (Ashworth >2) due to inability to exercise
- Recent history (<3 months) of illicit drug or alcohol abuse or diagnosis of significant mental illness
- Major post-stroke depression (Patient Health Questionnaire, PHQ-9 ≥ 1084)
- Currently participating in physical therapy targeting lower extremity function or another interventional study that may influence study outcomes
- Other significant neurologic, orthopedic or peripheral vascular conditions that would limit exercise participation
- Oxygen-dependent chronic obstructive pulmonary disease
- Diagnosis of other neurological disease (Multiple Sclerosis, Alzheimer's disease, Parkinson's disease)
- Self report pregnancy
堪萨斯大学229 个活跃的临床试验可供探索Kansas