Aphasia Physical EXercise Study: Randomized Trial

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• University of California, San Francisco

  collaborator OTHER

• California State University, East Bay

  collaborator OTHER

• University of San Francisco

  collaborator OTHER

• National Institute on Deafness and Other Communication Disorders (NIDCD)

  collaborator NIH

• University of California, Berkeley

  lead OTHER

Principal Investigators

• Maria Ivanova, PhD · University of California, Berkeley

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-01

Primary Completion

2029-12-31

Completion

2030-03-01

Countries

• United States

Study Locations