Recruiting

High-Intensity Exercise

Sponsor:

UCLA

Code:

NCT07281313

Conditions

Aphasia, Acquired

Aphasia

Aphasia, Fluent

Aphasia, Non-fluent

Aphasia Following Cerebral Infarction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

High-intensity physical exercise

Low-intensity physical exercise

Study Details

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.

Conditions

Aphasia, Acquired

Aphasia

Aphasia, Fluent

Aphasia, Non-fluent

Aphasia Following Cerebral Infarction

Study ID

NCT07281313

Start date

Dec 1, 2025

Status verified date

Mar, 2026

Completion date

Mar 1, 2030

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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 and Locations

Central contacts

Maria Ivanova, PhD

650-390-7572ivanova@berkeley.edu

Locations

University of California, Berkeley

Recruiting

Berkeley, California, United States, 94720

Contacts

Maria Ivanova, PhD

650-390-7572ivanova@berkeley.edu

California State University, East Bay

Recruiting

Hayward, California, United States, 94542

Contacts

Michelle Gravier, PhD

michelle.gravier@csueastbay.edu

University of San Francisco

Recruiting

San Francisco, California, United States, 94118

Contacts

Christian J Thompson, Ph.D.

cjthompson@usfca.edu

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Cathra Halabi, MD

Cathra.Halabi@ucsf.edu

More Information

Sponsor

University of California, Berkeley

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

  • aphasia
  • physical exercise
  • high intensity interval training
  • cognition
  • physical fitness
  • balance
  • stroke
  • language

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Berkeley on 2026-03-19.