High-Intensity Training for Stroke
(F-ITT Trial)
Recruiting in Palo Alto (17 mi)
Overseen byThomas G Hornby, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Indiana University
Must not be taking: Botox
Disqualifiers: Cerebellar ataxia, Uncontrolled cardiopulmonary, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
The purpose of this pilot study is to investigate the potential role of training frequency on locomotor outcomes following high-intensity gait training and provision of a home walking program.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What data supports the effectiveness of the treatment High-Intensity Gait Training for stroke patients?
Research shows that physical fitness training, including high-intensity treadmill training, can improve walking ability, physical activity, and cardiorespiratory fitness in stroke patients. Additionally, interventions like aerobic and resistance training have been found to enhance physical activity and functional recovery after a stroke.12345
Is high-intensity training generally safe for humans?
Research on physical fitness training in stroke patients shows that it can be safe, but there are risks of serious adverse events, especially in high-risk individuals. It's important to balance promoting physical activity with minimizing risks, and medical clearance is recommended before starting such programs.678910
How is physical activity coaching different from other treatments for stroke?
Physical activity coaching for stroke involves high-intensity interval training (HIT), which uses short bursts of intense exercise followed by rest periods. This approach is more effective than traditional aerobic exercise in improving fitness and recovery, making it a unique and promising option for stroke rehabilitation.1112131415
Eligibility Criteria
This trial is for individuals aged 18-85 who have had a stroke more than 6 months ago, can follow simple instructions, weigh less than 350 pounds, and can walk at certain speeds with or without braces or walking aids. They must also be medically cleared to participate.Inclusion Criteria
I am between 18 and 85 years old.
Unilateral deficits following stroke > 6 months prior; individuals > 4 months post-stroke eligible for consenting, final eligibility and potential enrollment after > 6 months
Weight < 350 pounds
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Exclusion Criteria
I have coordination problems due to cerebellar ataxia.
I don't have heart, lung, or metabolic diseases that limit my ability to exercise, nor do I have a history of frequent bone fractures or injuries that would affect my ability to move.
I am currently in a physical therapy program.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Testing
Baseline testing to confirm eligibility and assess initial locomotor and community outcomes
1 week
Treatment
Participants receive high-intensity gait training and activity coaching
6-12 weeks
18 visits (in-person)
Follow-up
Participants are monitored for locomotor and community outcomes after treatment
12 weeks
Treatment Details
Interventions
- High-intensity gait training (Other)
- Physical activity coaching (Behavioral Intervention)
Trial OverviewThe study is testing how often people should do high-intensity gait training combined with home walking programs to improve their ability to walk after having a stroke. It's a pilot study which means it's an early test of this approach.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: High frequencyExperimental Treatment2 Interventions
Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 6 weeks
Group II: Low frequencyActive Control2 Interventions
Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 12 weeks
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rehabilitation Hospital of IndianaIndianapolis, IN
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Who Is Running the Clinical Trial?
Indiana UniversityLead Sponsor
References
Efficacy of interventions aimed at improving physical activity in individuals with stroke: a systematic review. [2021]Purpose: To identify interventions employed to increase post-stroke physical activity, evaluate their efficacy, and identify the gaps in literature.Materials and methods: Randomized controlled trials published until March 2018 were searched in MEDLINE, PEDro, EMBASE, LILACS, and SCIELO databases. The quality of each study and overall quality of evidence were assessed using the PEDro and the GRADE scales.Results: Eighteen studies were included (good PEDro and very low GRADE-scores). In seven, the experimental groups showed significant increases in physical activity (aerobics, resistance, and home-based training; counseling, aerobics, resistance, and home-based training; electrical stimulation during walking; functional-task training; robot-assisted arm therapy; accelerometer-based feedback, and physical activity encouragement). In seven, there were no significant between-group differences (physical activity plan; stretching, use of toe-spreaders, standard treatment; counseling; circuit video-game; functional-task; counseling and cognitive training). The combined experimental and control groups showed significant declines in physical activity in one study (aerobic training or stretching) and increases in three others (aerobic, resistance or sham resistance training; stroke-with advice or only stroke-counseling; aerobic training, educational sessions, standard treatment, and coaching, or mobilization and standard treatment). A meta-analysis could not be performed, due to heterogeneity.Conclusions: Some interventions improved physical activity after stroke. However, the interpretability is limited.Implications for rehabilitationIndividuals with stroke show low physical activity, which may compromise function and health.The use of interventions aimed at improving and maintaining physical activity of individuals with stroke are recommended.Some interventions, such as aerobic, resistance, and combined home-based training, electrical stimulation during walking, functional task training, and arm robot-assisted therapy, could improve the physical activity after stroke.
High-intensity treadmill training and self-management for stroke patients undergoing rehabilitation: a feasibility study. [2021]Physical activity undertaken by stroke survivors is generally low. This trial investigated the feasibility of delivering a high-intensity treadmill and self-management program to people with stroke undergoing inpatient rehabilitation and determine whether physical activity, walking ability and cardiorespiratory fitness could be increased.
Physical fitness training for stroke patients. [2023]Levels of physical activity and physical fitness are low after stroke. Interventions to increase physical fitness could reduce mortality and reduce disability through increased function.
Consumer-Based Physical Activity Monitor as a Practical Way to Measure Walking Intensity During Inpatient Stroke Rehabilitation. [2018]Identifying practical ways to accurately measure exercise intensity and dose in clinical environments is essential to advancing stroke rehabilitation. This is especially relevant in monitoring walking activity during inpatient rehabilitation where recovery is greatest. This study evaluated the accuracy of a readily available consumer-based physical activity monitor during daily inpatient stroke rehabilitation physical therapy sessions.
[Adapted exercise important after stroke. Acute and long-term effects of different training programs]. [2017]Following stroke, persons experience deficits in motor control, reduced muscle strength, disuse atrophy, reduced cardiovascular fitness and elevated energy expenditure during locomotion. Recent exercise studies with few subjects, report beneficial outcomes after strength and low intensity aerobic exercise training. Progressive strength and aerobic exercise programmes from 3 to 6 months produced gains in functional recovery and health-related functional status such as motor function, peak isokinetic torque, balance, endurance, peak aerobic capacity and overall fitness without exacerbating spasticity. Increased access to community-based physical activity programmes is recommended to prevent deconditioning and to improve health related quality of life in persons after stroke. Well-functioning rehabilitation from acute care, through special rehabilitation units to community-based physical activity programmes is important.
Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): Safety analyses of a randomized clinical trial. [2022]To report the six-month safety analyses among patients enrolled in the "Physical Fitness Training in Subacute Stroke-PHYS-STROKE" trial and identify underlying risk factors associated with serious adverse events.
Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. [2015]To present detailed adverse event (AE) data from a randomized controlled trial (RCT) of a home-based exercise program delivered to an elderly high-risk population by an exercise therapist after medical clearance from a general practitioner (GP).
Adverse events in cardiovascular-related training programs in people with spinal cord injury: a systematic review. [2021]There are anecdotal reports of adverse events (AEs) associated with exercise in people with spinal cord injury (SCI) and consequent concern by people with SCI and their providers about potential risks of exercise. Enumeration of specific events has never been performed and the extent of risk of exercise to people with SCI is not understood.
Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]For high-risk individuals and their healthcare providers, finding the right balance between promoting physical activity and minimizing the risk of adverse events can be difficult. More information on the prevalence and influence of adverse events is needed to improve providers' ability to prescribe effective and safe exercise programs for their patients.
Physical inactivity is a strong risk factor for stroke in the oldest old: Findings from a multi-ethnic population (the Northern Manhattan Study). [2018]Background The fastest growing segment of the population is those age ≥80 who have the highest stroke incidence. Risk factor management is complicated by polypharmacy-related adverse events. Aims To characterize the impact of physical inactivity for stroke by age in a multi-ethnic prospective cohort study (NOMAS, n = 3298). Methods Leisure time physical activity was assessed by a validated questionnaire and our primary exposure was physical inactivity (PI). Participants were followed annually for incident stroke. We fit Cox-proportional hazard models to calculate hazard ratios and 95% confidence intervals (HR 95% CI) for the association of PI and other risk factors with risk of stroke including two-way interaction terms between the primary exposures and age (
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.
High-intensity training in patients with lacunar stroke: A one-year follow-up. [2023]Physical inactivity is a major risk factor for stroke. It is a challenge for patients to initiate and adhere to regular exercise post-stroke. Early initiation of home-based high-intensity interval training (HIIT) may engage patients in physical activity, improve cardiorespiratory fitness, and reduce risk of recurrent stroke.
Feasibility of single session high-intensity interval training utilizing speed and active recovery to push beyond standard practice post-stroke. [2022]Improvement in overground walking speed reduces dependency and is a central focus in post-stroke rehabilitation. Previous studies have shown that high-intensity interval training (HIT) can significantly improve functional and health-related outcomes in neurologically health individuals more so than traditional approaches. Emerging evidence suggests the same may be true post-stroke.
What Is Intensity and How Can It Benefit Exercise Intervention in People With Stroke? A Rapid Review. [2023]Background: Stroke is one of the major causes of chronic physical disability in the United Kingdom, typically characterized by unilateral weakness and a loss of muscle power and movement coordination. When combined with pre-existing comorbidities such as cardiac disease and diabetes, it results in reductions in cardiovascular (CV) fitness, physical activity levels, functional capacity, and levels of independent living. High-intensity training protocols have shown promising improvements in fitness and function for people with stroke (PwS). However, it remains unclear how intensity is defined, measured, and prescribed in this population. Further, we do not know what the optimal outcome measures are to capture the benefits of intensive exercise. Aim: To understand how intensity is defined and calibrated in the stroke exercise literature to date and how the benefits of high-intensity training in PwS are measured. Methods: A rapid review of the literature was undertaken to provide an evidence synthesis that would provide more timely information for decision-making (compared with a standard systematic review). Electronic databases were searched (including Medline, PubMed, CINAHL, and Embase for studies from 2015 to 2020). These were screened by title and abstract for inclusion if they: (a) were specific to adult PwS; and (b) were high-intensity exercise interventions. Eligible studies were critically appraised using the Mixed Method Appraisal Tool (MMAT). The data extraction tool recorded the definition of intensity, methods used to measure and progress intensity within sessions, and the outcomes measure used to capture the effects of the exercise intervention. Results: Seventeen studies were selected for review, 15 primary research studies and two literature reviews. Sixteen of the 17 studies were of high quality. Nine of the primary research studies used bodyweight-supported treadmills to achieve the high-intensity training threshold, four used static exercise bikes, and two used isometric arm strengthening. Five of the primary research studies had the aim of increasing walking speed, five aimed to increase CV fitness, three aimed to improve electroencephalogram (EEG) measured cortical evoked potentials and corticospinal excitability, and two investigated any changes in muscle strength. Although only one study gave a clear definition of intensity, all studies clearly defined the high-intensity protocol used, with most (15 out of 17 studies) clearly describing threshold periods of high-intensity activity, followed by rest or active recovery periods (of varying times). All of the studies reviewed used outcomes specific to body structure and function (International Classification of Functioning, Disability, and Health (ICF) constructs), with fewer including outcomes relating to activity and only three outcomes relating to participation. The reported effect of high-intensity training on PwS was promising, however, the underlying impact on neurological, musculoskeletal, and CV systems was not clearly specified. Conclusions: There is a clear lack of definition and understanding about intensity and how thresholds of intensity in this population are used as an intervention. There is also an inconsistency about the most appropriate methods to assess and provide a training protocol based on that assessment. It remains unclear if high-intensity training impacts the desired body system, given the diverse presentation of PwS, from a neuromuscular, CV, functional, and psychosocial perspective. Future work needs to establish a clearer understanding of intensity and the impact of exercise training on multiple body systems in PwS. Further understanding into the appropriate assessment tools to enable appropriate prescription of intensity in exercise intervention is required. Outcomes need to capture measures specific not only to the body system, but also level of function and desired goals of individuals.
Effects of a high-intensity task-oriented training on gait performance early after stroke: a pilot study. [2022]To investigate the feasibility and the effects on gait of a high intensity task-oriented training, incorporating a high cardiovascular workload and large number of repetitions, in patients with subacute stroke, when compared to a low intensity physiotherapy-programme.