RecruitingNot ApplicableNCT07281313

Aphasia Physical EXercise Study: Randomized Trial

High-intensity Exercise in Stroke Recovery: Randomized Trial


Sponsor

University of California, Berkeley

Enrollment

120 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

  • 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 Criteria3

  • 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

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Interventions

BEHAVIORALHigh-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.

BEHAVIORALLow-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.


Locations(4)

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

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NCT07281313


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