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Principal Investigator: Pierce Boyne
Organization: UNIVERSITY OF CINCINNATI
Fiscal Year: 2024
Award: $679,886
Funding agency: Eunice Kennedy Shriver National Institute of Child Health and Human Development
PROJECT SUMMARY / ABSTRACT
Among the 7 million stroke survivors living in the U.S., fewer than 10% have adequate walking speed and
endurance to complete normal daily activities like grocery shopping, which leads to a loss of life roles. Stroke
rehabilitation guidelines recommend moderate-intensity aerobic training (MAT) via walking exercise to address
this limitation in walking capacity. However, recent evidence suggests that MAT may have negligible effects
among many people in the chronic phase of stroke (>6 months post stroke), especially those with severe gait
impairment (speed <0.4 m/s). There is growing belief that a more vigorous training intensity (>60% heart rate
reserve vs 40-60%) may be critical for eliciting greater improvements in walking capacity. Yet, the optimal
training intensity has been difficult to determine among stroke survivors because neurologic impairments make
it challenging to reach vigorous intensity. This study will use a novel training protocol to overcome this
limitation. Based on the well-tested exercise science and cardiac rehabilitation strategy of high-intensity
interval training (HIT), this protocol uses bursts of maximum speed walking alternating with recovery periods, to
sustain higher intensities than physiologically possible with continuous exercise and with less perceived
exertion. Preliminary results suggest that this innovative locomotor HIT protocol may improve walking capacity
and other outcomes significantly more than MAT, and that it could be uniquely effective among patients with
severe gait impairment, a subgroup that has not yet shown meaningful responses to MAT or other
interventions. However, no previous studies have been large enough to test whether a more vigorous training
program like HIT increases benefit more than risk, yields sustained gains in walking capacity beyond the end of
training or elicits significantly greater improvement than moderate-intensity training among patients with severe
gait impairment. In this study, 156 people at least 6 months post-stroke at 3 research sites across the U.S. will
be randomized to perform either a HIT or MAT program, each involving 45 minutes of walking exercise with a
physical therapist, 3 times per week for 12 weeks. Walking function, fatigue, aerobic capacity, and quality of life
will be assessed by blinded raters at baseline, after 4, 8 and 12 weeks of training and 3 months after training
ends, while safety will be monitored throughout. The primary statistical analysis will then determine which
training intensity is better (vigorous or moderate) for safely producing meaningful and sustained improvements
in walking capacity in chronic stroke. A second analysis will also assess whether vigorous training intensity is
particularly critical for patients with severe gait impairment. At study completion, we expect to have gained
foundational knowledge about how to select training intensity to maximize recovery of walking function after
stroke. This new knowledge will likely lead to better outcomes in future studies and clinical rehabilitation, thus
making a positive impact on the disability burden of stroke.
Terms: <Abnormal gait><Active Follow-up><Address><Adverse Experience><Adverse event><Aerobic><Aerobic Activity><Aerobic Exercise><Aerobic Training><Aerobic fitness><Apoplexy><Attention><Award><Belief><Blinded><Brain Vascular Accident><COVID-19><CV-19><Cardiac Chronotropism><Cardiac rehabilitation><Cell Communication and Signaling><Cell Signaling><Cerebral Stroke><Cerebrovascular Apoplexy><Cerebrovascular Stroke><Chronic Phase><Clinical><Clinical Trials><Coronavirus Infectious Disease 2019><Data><Dose><Enrollment><Evidence based treatment><Exercise><Exercise Test><Exertion><Fatigue><Funding><Future><Gait abnormality><Gait disorder><Gait disturbances><Gait dysfunction><Gait impairment><Government><Guidelines><Heart Rate><Human Resources><Impairment><Individual><Infrastructure><Interruption><Interval training><Intervention><Intervention Strategies><Intracellular Communication and Signaling><Knowledge><Lack of Energy><Life><Locomotor training><Manpower><Measures><Medical Rehabilitation><Methods><Modeling><Monitor><Neurologic><Neurological><Outcome><Participant><Patients><Persons><Physiologic><Physiological><Process><Prognosis><Protocol><Protocols documentation><QOL><Quality of life><Randomized><Recommendation><Recovery><Rehabilitation><Rehabilitation therapy><Research><Research Resources><Resources><Risk><Role><Safety><Sampling><Science><Signal Transduction><Signal Transduction Systems><Signaling><Single-Blind Study><Single-blind><Site><Speed><Statistical Data Analyses><Statistical Data Analysis><Statistical Data Interpretation><Stroke><Subgroup><Testing><Time><Training><Training Programs><Waiting Lists><Walking><Walking impairment><Withdrawal><active followup><after stroke><biological signal transduction><brain attack><cardiac rehab><cerebral vascular accident><cerebrovascular accident><chronic stroke><clinical care><clinical practice><coronavirus disease 2019><coronavirus disease-19><coronavirus infectious disease-19><disability burden><enroll><follow up><follow-up><followed up><followup><heart rehabilitation><improved><individual patient><innovate><innovation><innovative><interest><interventional strategy><meter><novel><patient subclass><patient subcluster><patient subgroups><patient subpopulations><patient subsets><patient subtypes><personnel><physical therapist><physiotherapist><post stroke><poststroke><randomisation><randomization><randomly assigned><rehab strategy><rehab therapy><rehabilitation after stroke><rehabilitation strategy><rehabilitative><rehabilitative therapy><response><social role><statistical analysis><stroke rehab><stroke rehabilitation><stroke survivor><stroke trials><stroked><strokes><trial comparing><vigorous intensity><waitlist><walking pace><walking speed>