NCT07281313 Aphasia Physical EXercise Study: Randomized Trial
| NCT ID | NCT07281313 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Berkeley |
| Condition | Aphasia, Acquired |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-12-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 * 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: * 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
Contact & Investigator
Maria Ivanova, PhD
PRINCIPAL INVESTIGATOR
University of California, Berkeley
Frequently Asked Questions
Who can join the NCT07281313 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Aphasia, Acquired. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07281313 currently recruiting?
Yes, NCT07281313 is actively recruiting participants. Contact the research team at ivanova@berkeley.edu for enrollment information.
Where is the NCT07281313 trial being conducted?
This trial is being conducted at Berkeley, United States, Hayward, United States, San Francisco, United States, San Francisco, United States.
Who is sponsoring the NCT07281313 clinical trial?
NCT07281313 is sponsored by University of California, Berkeley. The principal investigator is Maria Ivanova, PhD at University of California, Berkeley. The trial plans to enroll 120 participants.