Exercise for Stroke Recovery
(FAST Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Kansas Medical Center
Must be taking: Statins
Disqualifiers: Cardiac disease, Pulmonary disease, Ataxia, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?People living with stroke have very low aerobic fitness, which can negatively impact brain health. Identifying the best exercise which includes exercise stimulus type (interval, continuous) or intensity, how hard to exercise (moderate, high) that benefit aerobic fitness, vascular health, and the brain's main blood vessels after stroke are unknown. This study is designed to determine the preliminary efficacy of high-volume HIIT to moderate intensity exercise using a seated stepper exercise device that allows the arms and legs to move back and forth.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it does require that your blood pressure and statin medication doses remain stable for 30 days before joining the study.
What data supports the effectiveness of the treatment Exercise HIIT and MICT for stroke recovery?
Research shows that high-intensity interval training (HIIT) can lead to greater improvements in fitness and walking ability after a stroke compared to moderate-intensity continuous training (MICT). HIIT has been found to significantly enhance cardiorespiratory fitness, which is important for overall recovery.
12345Is exercise, including HIIT and MICT, safe for humans?
Research shows that high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) are generally safe for humans, including those with cardiovascular conditions and stroke. HIIT has a low rate of major adverse events and no acute injuries were reported in studies, making it a safe option for improving fitness.
16789How does the treatment 'Exercise HIIT and MICT' differ from other treatments for stroke recovery?
Exercise HIIT (High-Intensity Interval Training) and MICT (Moderate-Intensity Continuous Training) are unique because they focus on improving cardiovascular fitness and promoting neuroplasticity (the brain's ability to reorganize itself) through varying exercise intensities. Unlike traditional continuous exercise, HIIT involves short bursts of intense activity followed by rest, which may lead to better fitness and mobility improvements post-stroke.
1231011Eligibility Criteria
This trial is for adults aged 20-85 who've had a stroke (ischemic or hemorrhagic) between 6 months and 5 years ago. Participants should be able to exercise minimally, walk with assistive devices without constant help, and not be very active currently. Excluded are those with severe spasticity, recent substance abuse, certain medical conditions like severe COPD or neurological diseases, pregnant women, recent hospitalizations for heart/lung issues, pacemakers that limit exercise, significant pain affecting daily life or depression.Inclusion Criteria
I can understand and follow instructions and answer questions about the study.
I can walk with tools like a cane but don’t need someone to help me all the time.
I can safely do moderate exercise without health risks.
+5 more
Exclusion Criteria
You have a pacemaker or defibrillator that restricts your ability to exercise.
I need oxygen therapy for my COPD.
I have severe leg stiffness because I can't exercise.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants engage in a 4-week exercise program using a seated stepper, allocated to either moderate intensity continuous training (MICT) or high-intensity interval training (HIIT)
4 weeks
4 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of cerebral blood flow, gait speed, oxygen uptake, and vascular function
4 weeks
Participant Groups
The study tests the effectiveness of high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) on aerobic fitness in stroke survivors using a seated stepper device. It aims to find out which type and intensity of exercise best improve fitness levels and vascular health after a stroke.
2Treatment groups
Active Control
Group I: High intensity, interval exercise (HIIT)Active Control1 Intervention
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.
Group II: Moderate intensity, continuous training (MICT)Active Control1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Kansas Medical CenterKansas City, KS
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Who Is Running the Clinical Trial?
University of Kansas Medical CenterLead Sponsor
References
Addition of high-intensity interval training to a moderate intensity continuous training cardiovascular rehabilitation program after ischemic cerebrovascular disease: A randomized controlled trial. [2023]Moderate intensity continuous training (MICT) is usually recommended for stroke or transient ischemic attack (TIA) patients. High intensity interval training (HIIT) has emerged as a potentially effective method for increasing cardiorespiratory fitness (CRF) among clinical populations. Its effectiveness remains to be demonstrated after stroke. A combined program of HIIT and MICT was designed to create a realistic exercise program implemented for a clinical setting to help patients become more active.
High-Intensity Interval Training and Moderate-Intensity Continuous Training in Ambulatory Chronic Stroke: Feasibility Study. [2018]Poststroke guidelines recommend moderate-intensity, continuous aerobic training (MCT) to improve aerobic capacity and mobility after stroke. High-intensity interval training (HIT) has been shown to be more effective than MCT among healthy adults and people with heart disease. However, HIT and MCT have not been compared previously among people with stroke.
Effectiveness of High-Intensity Interval Training for Fitness and Mobility Post Stroke: A Systematic Review. [2020]To evaluate the evidence on the effectiveness of high-intensity interval training (HIIT) in improving fitness and mobility post stroke. TYPE: Systematic review.
Effect of High-Intensity Interval Training and Moderate-Intensity Continuous Training in People With Poststroke Gait Dysfunction: A Randomized Clinical Trial. [2023]>Background The exercise strategy that yields the greatest improvement in both cardiorespiratory fitness (V̇O2peak$$ dot{mathrm{V}}{mathrm{O}}_{2mathrm{peak}} $$) and walking capacity poststroke has not been determined. This study aimed to determine whether conventional moderate-intensity continuous training (MICT) or high-intensity interval training (HIIT) have different effects on V̇O2peak$$ dot{mathrm{V}}{mathrm{O}}_{2mathrm{peak}} $$ and 6-minute walk distance (6MWD). Methods and Results In this 24-week superiority trial, people with poststroke gait dysfunction were randomized to MICT (5 days/week) or HIIT (3 days/week with 2 days/week of MICT). MICT trained to target intensity at the ventilatory anaerobic threshold. HIIT trained at the maximal tolerable treadmill speed/grade using a novel program of 2 work-to-recovery protocols: 30:60 and 120:180 seconds. V̇O2 and heart rate was measured during performance of the exercise that was prescribed at 8 and 24 weeks for treatment fidelity. Main outcomes were change in V̇O2peak$$ dot{mathrm{V}}{mathrm{O}}_{2mathrm{peak}} $$ and 6MWD. Assessors were blinded to the treatment group for V̇O2peak$$ dot{mathrm{V}}{mathrm{O}}_{2mathrm{peak}} $$ but not 6MWD. Secondary outcomes were change in ventilatory anaerobic threshold, cognition, gait-economy, 10-meter gait-velocity, balance, stair-climb performance, strength, and quality-of-life. Among 47 participants randomized to either MICT (n=23) or HIIT (n=24) (mean age, 62±11 years; 81% men), 96% completed training. In intention-to-treat analysis, change in V̇O2peak$$ dot{mathrm{V}}{mathrm{O}}_{2mathrm{peak}} $$ for MICT versus HIIT was 2.4±2.7 versus 5.7±3.1 mL·kg-1·min-1 (mean difference, 3.2 [95% CI, 1.5-4.8]; P<0.001), and change in 6MWD was 70.9±44.3 versus 83.4±53.6 m (mean difference, 12.5 [95% CI, -17 to 42]; P=0.401). HIIT had greater improvement in ventilatory anaerobic threshold (mean difference, 2.07 mL·kg-1·min-1 [95% CI, 0.59-3.6]; P=0.008). No other between-group differences were observed. During V̇O2 monitoring at 8 and 24 weeks, MICT reached 84±14% to 87±18% of V̇O2peak$$ dot{mathrm{V}}{mathrm{O}}_{2mathrm{peak}} $$ while HIIT reached 101±22% to 112±14% of V̇O2peak$$ dot{mathrm{V}}{mathrm{O}}_{2mathrm{peak}} $$ (during peak bouts). Conclusions HIIT resulted in more than a 2-fold greater and clinically important change in V̇O2peak$$ dot{mathrm{V}}{mathrm{O}}_{2mathrm{peak}} $$ than MICT. Training to target (ventilatory anaerobic threshold) during MICT resulted in ~3 times the minimal clinically important difference in 6MWD, which was similar to HIIT. These findings show proof of concept that HIIT yields greater improvements in cardiorespiratory fitness than conventional MICT in appropriately screened individuals. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03006731.
Effect of home-based high-intensity interval training versus moderate-intensity continuous training in patients with myocardial infarction: a randomized controlled trial. [2022]Supervised high-intensity interval training (HIIT) has been proposed to be more effective than moderate-intensity continuous training (MICT) for improving exercise capacity, but there are not sufficient information effects of home-based HIIT and MICT in patients with myocardial infarction (MI).
High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. [2021]Background Cardiac rehabilitation ( CR ) for patients with cardiovascular disease has traditionally involved low- to moderate-intensity continuous aerobic exercise training ( MICT ). There is growing and robust evidence that high-intensity interval training ( HIIT ) shows similar or greater efficacy compared with MICT across a range of cardiovascular and metabolic measures, in both healthy populations and populations with a chronic illness. However, there is understandable concern about the safety aspects of applying HIIT in CR settings. This systematic review analyzed safety data drawn from recent proof-of-concept studies of HIIT during CR among patients with cardiovascular disease. Methods and Results We included trials comparing HIIT with either MICT or usual care in patients with coronary artery disease or heart failure participating in tertiary care services, such as phase 2 (outpatient) CR . Adverse events occurring during or up to 4 hours after an exercise training session were collated. There were 23 studies included, which analyzed 1117 participants ( HIIT =547; MICT =570). One major cardiovascular adverse event occurred in relation to an HIIT session, equating to 1 major cardiovascular event per 17 083 training sessions (11 333 training hours). One minor cardiovascular adverse events and 3 noncardiovascular adverse events (primarily musculoskeletal complaints) were also reported for HIIT . Two noncardiovascular events were reported in relation to MICT . Conclusions HIIT has shown a relatively low rate of major adverse cardiovascular events for patients with coronary artery disease or heart failure when applied within CR settings.
Safety and improvement in exercise tolerance with interval training vs moderate-intensity continuous training in heart disease patient of very high cardiovascular risk. [2022]Evaluate safety and effects of training at moderate and high intensity intervals (MIIT, HIIT) compared to continuous moderate intensity training (MICT) in heart disease patient with very high cardiovascular risk (CVR).
Effect of Home-Based High-Intensity Interval Training in Patients With Lacunar Stroke: A Randomized Controlled Trial. [2023]Background: High-intensity interval training (HIIT) is superior to moderate-intensity continuous training in improving cardiorespiratory fitness in patients with cardiovascular disease, but is it safe, feasible and effective in patients with stroke? We investigated feasibility and effect of early, home-based HIIT in patients with lacunar stroke combined with usual care vs. usual care, only. Methods: Patients with minor stroke (severity: 55/58 point on the Scandinavian Stroke Scale) were randomized to HIIT or usual care in a randomized, controlled trial. We measured the following outcomes at baseline and post-intervention: cardiorespiratory fitness monitored as power output from the Graded Cycling Test with Talk Test (GCT-TT; primary outcome), physical activity, fatigue, depression, well-being, stress, cognition, endothelial function, blood pressure, body mass index, and biomarkers. Results: We included 71 patients (mean age 63.7 ± 9.2), 49 men, 31 in intervention group. Home-based HIIT was feasible with no reported adverse events in relation to the intervention. No significant change between the groups in GCT-TT power output was detected (p = 0.90). The change in time spent on vigorous-intensity activity was 2 h/week and 0.6 h/week, intervention and usual care, respectively (p = 0.045). There were no significant differences between groups in the remaining secondary outcomes. Conclusion: HIIT was feasible and safe in patients with lacunar stroke. Patients can engage early in home-based HIIT when involved in choosing exercise modality and guided by weekly motivational phone calls. Within 3 months, HIIT did, however, not yield effect on cardiorespiratory fitness. We await further evaluation of long-term effects of this intervention on continued regular physical exercise and cardiovascular event. Clinical Trial Registration: https://clinicaltrials.gov, identifier NCT02731235.
Can high-intensity interval training improve physical and mental health outcomes? A meta-review of 33 systematic reviews across the lifespan. [2023]High-intensity-interval-training (HIIT) has been suggested to have beneficial effects in multiple populations across individual systematic reviews, although there is a lack of clarity in the totality of the evidence whether HIIT is effective and safe across different populations and outcomes. The aim of this meta-review was to establish the benefits, safety and adherence of HIIT interventions across all populations from systematic reviews and meta-analyses. Major databases were searched for systematic reviews (with/without meta-analyses) of randomised & non-randomised trials that compared HIIT to a control. Thirty-three systematic reviews (including 25 meta-analyses) were retrieved encompassing healthy subjects and people with physical health complications. Evidence suggested HIIT improved cardiorespiratory fitness, anthropometric measures, blood glucose and glycaemic control, arterial compliance and vascular function, cardiac function, heart rate, some inflammatory markers, exercise capacity and muscle mass, versus non-active controls. Compared to active controls, HIIT improved cardiorespiratory fitness, some inflammatory markers and muscle structure. Improvements in anxiety and depression were seen compared to pre-training. Additionally, no acute injuries were reported, and mean adherence rates surpassed 80% in most systematic reviews. Thus, HIIT is associated with multiple benefits. Further large-scale high-quality studies are needed to reaffirm and expand these findings.Abbreviations: ACSM: American College of Sports Medicine; BMI: Body Mass Index; BNP: Brain Natriuretic Peptide; BP: Blood Pressure; CAD: Coronary Artery Disease; CHD: Coronary Heart Disease; COPD: Chronic Obstructive Pulmonary Disease; CRP: c- reactive Protein; CVD: Cardiovascular Disease; DBP: Diastolic Blood Pressure; ES: Effect Size; FAS: Reduced Fatty Acid Synthase; FATP-1: Reduced Fatty Acid Transport Protein 1; FMD: Flow Mediated Dilation; Hs-CRP: High-sensitivity c- reactive Protein; HDL: High Density Lipoprotein; HIIT: High-Intensity Interval Training; HOMA: Homoeostatic Model Assessment; HR: Heart Rate; HTx: Heart Transplant Recipients; IL-6: Interleukin-6; LDL: Low Density Lipoprotein; LV: Left Ventricular; LVEF: Left Ventricular Ejection Fraction; MD: Mean Difference; MetS: Metabolic Syndrome; MPO: Myeloperoxidase; MICT: Moderate-Intensity Continuous Training; NO: Nitric Oxide; NRCT: Non-Randomised Controlled Trial; PA: Physical Activity; PAI-1: Plasminogen-activator-inhibitor-1; QoL: Quality of Life; RCT: Randomised Controlled Trial; RoB: Risk of Bias; RPP: Rate Pressure Product; RT: Resistance Training; SBP: Systolic Blood Pressure; SD: Standardised Difference; SMD: Standardised Mean Difference; TAU: Treatment-As-Usual; T2DM: Type 2 Diabetes Mellitus; TC: Total Cholesterol; TG: Triglycerides; TNF-alfa: Tumour Necrosis Factor alpha; UMD: Unstandardised Mean Difference; WC: Waist Circumference; WHR: Waist-to-Hip Ratio; WMD: Weighted Mean DifferenceKey points: HIIT may improve cardiorespiratory fitness, cardiovascular function, anthropometric variables, exercise capacity, muscular structure and function, and anxiety and depression severity in healthy individuals and those with physical health disorders.Additionally, HIIT appears to be safe and does not seem to be associated with acute injuries or serious cardiovascular events.
Intensity matters: protocol for a randomized controlled trial exercise intervention for individuals with chronic stroke. [2022]Cardiovascular exercise is an effective method to improve cardiovascular health outcomes, but also promote neuroplasticity during stroke recovery. Moderate-intensity continuous cardiovascular training (MICT) is an integral part of stroke rehabilitation, yet it may remain a challenge to exercise at sufficiently high intensities to produce beneficial adaptations to neuroplasticity. High-intensity interval training (HIIT) could provide a viable alternative to achieve higher intensities of exercise by using shorter bouts of intense exercise interspersed with periods of recovery.
High-intensity interval training in stroke rehabilitation. [2021]After stroke, people with weakness enter a vicious cycle of limited activity and deconditioning that limits functional recovery and exacerbates cardiovascular risk factors. Conventional aerobic exercise improves aerobic capacity, function, and overall cardiometabolic health after stroke. Recently, a new exercise strategy has shown greater effectiveness than conventional aerobic exercise for improving aerobic capacity and other outcomes among healthy adults and people with heart disease. This strategy, called high-intensity interval training (HIT), uses bursts of concentrated effort alternated with recovery periods to maximize exercise intensity. Three poststroke HIT studies have shown preliminary effectiveness for improving functional recovery. However, these studies were varied in approach and the safety of poststroke HIT has received little attention. The objectives of this narrative review are to (1) propose a framework for categorizing HIT protocols; (2) summarize the safety and effectiveness evidence of HIT among healthy adults and people with heart disease and stroke; (3) discuss theoretical mechanisms, protocol selection, and safety considerations for poststroke HIT; and (4) provide directions for future research.