Aphasia Physical EXercise Study: Randomized Trial

Part of paid clinical trials in Berkeley, California.

Sponsor
University of California, Berkeley
Study ID
NCT07281313
Status
Recruiting
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Conditions

  • Aphasia
  • Aphasia Following Cerebral Infarction
  • Aphasia Following Nontraumatic Intracerebral Hemorrhage
  • Aphasia, Acquired
  • Aphasia, Fluent
  • Aphasia, Non-fluent

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • High-intensity physical exercise — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Dec 1, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2029
Completion
Mar 1, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: Low-intensity physical exercise
    The participants will participate in a low-intensity non-aerobic exercise program for 12 weeks.

Primary Outcome Measure

Change on the Western Aphasia Battery (WAB) - Aphasia Quotient [ Time Frame: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of California, BerkeleyBerkeleyCalifornia94720
Maria Ivanova, PhD
[email protected]
650-390-7572
California State University, East BayHaywardCalifornia94542
Michelle Gravier, PhD
[email protected]
University of California, San FranciscoSan FranciscoCalifornia94143
Cathra Halabi, MD
[email protected]
University of San FranciscoSan FranciscoCalifornia94118
Christian J Thompson, Ph.D.
[email protected]

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