Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-12-31
2030-10-31
Brief Summary
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• 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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High-intensity physical exercise
The participants will take part in a high-intensity Aphasia Physical EXercise (APEX) intervention designed specifically for individuals with chronic post-stroke aphasia for 12 weeks.
High-intensity physical exercise
We 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
The participants will participate in a low-intensity non-aerobic exercise program for 12 weeks.
Low-intensity physical exercise
As 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.
Interventions
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High-intensity physical exercise
We 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
As 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* At least 8 years of education
* Between the ages of 18 and 80
* Independent with ambulation without a device (single-point cane accepted)
* Medically stable with no contraindications to participate in regular physical exercise as determined by the patients' own primary care provider or other treating provider.
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
California State University, East Bay
OTHER
University of San Francisco
OTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
University of California, Berkeley
OTHER
Responsible Party
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Maria Ivanova
Associate Professional Researcher
Principal Investigators
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Maria Ivanova, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Berkeley
Locations
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University of California, Berkeley
Berkeley, California, United States
California State University, East Bay
Hayward, California, United States
University of San Francisco
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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20243771
Identifier Type: -
Identifier Source: org_study_id
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