The goal of this clinical trial is to evaluate the effects of a high-intensity exercise program on recovery in individuals with post-stroke aphasia. The high-intensity exercise program has been specifically designed for individuals with post-stroke aphasia and includes an interval training full-body workout, which can increase cardiovascular fitness, improve muscle strength and motor performance, and maximize cognitive and language gains. The main question this study aims to answer is:
• Does participation in a high-intensity exercise program lead to changes in physical health, language, cognitive, motor recovery, psychological and/or psychosocial domains?
Participants will be randomly assigned to either a high-intensity exercise program (target intervention) or a low-intensity exercise program (control intervention) delivered over 12-weeks in a group setting.
Outcome measures will be collected once immediately after the intervention period and once during the following 12-week maintenance period to capture short- and long-term effects of the exercise program.
Aphasia following ischemic or hemorrhagic stroke
Aphasia as determined by a standardized language test (Western Aphasia Battery Aphasia Quotient < 93.8 at study intake)
At least 6 months from the last stroke
Proficient in English before the stroke
Prior history of dementia, neurologic illness (other than stroke), or recent (last 3 years) substance abuse
Significant visual or hearing disabilities (e.g., neglect, uncorrected visual or hearing loss) that interfere with testing
Self-report uncontrolled cardiorespiratory and/or metabolic disorders incompatible with exercise
Parallel
High-intensity physical exercise
BehavioralWe have developed a new exercise program specifically designed for individuals with post-stroke aphasia, Aphasia Physical EXercise (APEX), to provide a safe, stroke- and aphasia-friendly physical exercise intervention to achieve optimal physical fitness and cognitive/language gains. This intervention, based on published research and clinical practice recommendations, is a high-intensity interval training full-body workout optimized to accommodate the range of motor abilities and general deconditioning observed in stroke survivors.
Low-intensity physical exercise
BehavioralAs an active control intervention, a low-intensity non-aerobic exercise program was selected that mirrors more closely the standard-of-care physical therapy currently provided to stroke patients. This control intervention will offer the same level of participant involvement and type of interaction, but without the intensity element, i.e., it will not incorporate the cardiovascular and the strengthening components.
Change on the Western Aphasia Battery (WAB) - Aphasia Quotient
The Aphasia Quotient from the Western Aphasia Battery (a standardized language test) measures overall severity of language impairment in aphasia and ranges from 0 to 100, with lower scores indicative of more severe aphasia.
Change on the WAB subtest scores
The subtests from the Western Aphasia Battery (a standardized language test) measure different language capacities. Specifically, we will look at Spontaneous Speech, Fluency, Auditory Verbal Comprehension, Repetition, Naming and Word Finding subtest scores.
Change on the Curtiss-Yamada Comprehensive Language Evaluation - Revised (CYCLE-R)
A sentence-to-picture matching tasks that evaluates comprehension of sentences of varying complexity. The scores range from 0 to 100%, with higher scores indicative of better comprehension abilities.
Changes on Category and Letter Verbal Fluency tasks
Test of word retrieval and executive control abilities such as updating, shifting, and inhibiting. Participants are asked to name as many items as possible in 1 minute for a given category (e.g., clothes) and for a given letter (e.g., "s").
Change on the Philadelphia Naming Test (PNT)
Aphasia naming test to assess word retrieval abilities. The score ranges from 0 to 100, with a higher score indicating greater naming ability.
Changes on the Narrative Discourse Sample
Analysis of discourse samples elicited using the WAB-R picture description, the Cat rescue story and the Cinderella story retell, narrative tasks commonly used in aphasia research.
Changes on the Functional Gait Assessment (FGA)
A multi-component assessment of postural stability during walking and ability to perform additional motor tasks while walking.
Change in Center for Epidemiological Studies Depression Scale (CES-D)
The 20-item self-rating questionnaire evaluates perceived mood and level of functioning within the past seven days. The scores range from 0-60. A score equal to or above 16 indicates a person at risk for clinical depression.
Changes on the General Anxiety Disorder scale (GAD-7)
The 7-item self-report scale is used to identify anxiety based on problems experienced in the last two weeks. The scores range from 0-21, with higher scores indicative of more pronounced anxiety symptoms.
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University of California, Berkeley
Lead sponsor
University of California, San Francisco
Collaborator
California State University, East Bay
Collaborator
University of San Francisco
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
