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Aphasia Physical EXercise Study: Randomized Trial

Study acronym: APEX
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Oct 31, 2030 to Dec 31, 2029
    • Study completion date: Dec 31, 2031 to Mar 1, 2030
    v3
  2. Study completion date: Oct 31, 2030 to Dec 31, 2031
    • Start date changed from estimate of Dec 2025 to Dec 1, 2025
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07281313
Lead Sponsor University of California, Berkeley
Collaborators: University of California, San Francisco, California State University, East Bay, University of San Francisco, National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions
(from sponsor)		 Aphasia, Acquired, Aphasia, Aphasia, Fluent, Aphasia, Non-fluent, Aphasia Following Cerebral Infarction, Aphasia Following Nontraumatic Intracerebral Hemorrhage
Related terms Aphasia, Aphasia, Broca, Aphasia, Wernicke, Language, Motor Activity, Stroke
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov