Aphasia Physical EXercise Study: Randomized Trial (APEX)

University of California (UC), Berkeley

Status: Enrolling

Conditions: Aphasia, Fluent; Aphasia, Acquired; Aphasia Following Nontraumatic Intracerebral Hemorrhage; Aphasia Following Cerebral Infarction; Aphasia, Non-fluent; Aphasia

Treatments: Behavioral: High-intensity physical exercise; Behavioral: Low-intensity physical exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07281313

R01DC022663 (U.S. NIH Grant/Contract)

20243771

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

High-intensity physical exercise

Experimental group

Description:

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.

Treatment:

Behavioral: High-intensity physical exercise

Low-intensity physical exercise

Active Comparator group

Description:

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

Treatment:

Behavioral: Low-intensity physical exercise