Aphasia Physical EXercise Study: Randomized Trial

NCT07281313 | Recruiting

• 2 other identifiers: 20243771R01DC022663
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

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; Aphasia Following Nontraumatic Intracerebral Hemorrhage

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change on the Western Aphasia Battery (WAB) - Aphasia Quotient

  The Aphasia Quotient from the Western Aphasia Battery (a standardized language test) measures overall severity of language impairment in aphasia and ranges from 0 to 100, with lower scores indicative of more severe aphasia.

  (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.

Secondary Outcomes (11)

• Change on the WAB subtest scores

  (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.

• Change on the Curtiss-Yamada Comprehensive Language Evaluation - Revised (CYCLE-R)

  (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.

• Changes on Category and Letter Verbal Fluency tasks

  (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.

• Change on the Philadelphia Naming Test (PNT)

  (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.

• Changes on the California Cognitive Assessment Battery (CCAB)

  (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.

Other Outcomes (12)

• Changes on the Narrative Discourse Sample

  (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.

• Changes on the Functional Gait Assessment (FGA)

  (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.

• Change in Center for Epidemiological Studies Depression Scale (CES-D)

  (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.

Study Arms (2)

High-intensity physical exercise

EXPERIMENTAL

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.

Behavioral: High-intensity physical exercise

Low-intensity physical exercise

ACTIVE COMPARATOR

The participants will participate in a low-intensity non-aerobic exercise program for 12 weeks.

Behavioral: Low-intensity physical exercise

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.

High-intensity physical exercise

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.

Low-intensity physical exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Berkeley: lead
• California State University, East Bay: collaborator
• University of San Francisco: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• University of California, San Francisco: collaborator

Study Sites (4)

University of California, Berkeley

Berkeley, California, 94720, United States

RECRUITING

California State University, East Bay

Hayward, California, 94542, United States

RECRUITING

University of San Francisco

San Francisco, California, 94118, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Aphasia; Aphasia, Wernicke; Aphasia, Broca; Motor Activity; Stroke; Language

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Communication

Study Officials

• Maria Ivanova, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Ivanova, PhD

CONTACT

650-390-7572; ivanova@berkeley.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professional Researcher

Model Details: Participants will be randomly assigned to the low intensity intervention (control intervention) or the high-intensity physical exercise intervention (target intervention).

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 15, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (4)