Effects of High-intensity Exercise Training on Physical Fitness, Cognition, Language in Post-stroke Aphasia

University of California (UC), Berkeley

Status: Active, not recruiting

Conditions: Aphasia Non Fluent; Aphasia, Fluent; Aphasia, Acquired; Aphasia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06185023

056427-002

Details and patient eligibility

About

The goal of this clinical trial is to establish the feasibility and fidelity of a high-intensity exercise program for individuals with post-stroke aphasia. The main questions it aims to answer are:

• Is it feasible for stroke survivors with aphasia to participate in a long in-person physical exercise program?
• Does participation in a physical exercise program lead to physical fitness, cognitive, language and/or psychological changes?

Participants can take part in two different physical exercise interventions:

• Low intensity intervention (control intervention);
• High-intensity physical exercise intervention (target intervention).

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aphasia following single or multiple ischemic or hemorrhagic stroke;
• 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 patient's own primary care provider or other treating provider.

Exclusion criteria

• prior history of dementia, neurologic illness (other than stroke), or substance abuse;
• significant visual or hearing disabilities (e.g., neglect, uncorrected visual or hearing loss) that interfere with testing;
• per self-report uncontrolled cardiorespiratory and/or metabolic disorders incompatible with exercise.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Low-intensity physical exercise

Active Comparator group

Description:

The participants will participate in a low-intensity non-aerobic exercise program for 2 weeks.

Treatment:

Behavioral: Low-intensity physical exercise

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 8 weeks.

Treatment:

Behavioral: High-intensity physical exercise

High-intensity physical exercise - remote

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 4 weeks. The first week will be delivered in-person, while weeks 2-4 will be delivered remotely via live Zoom classes.

Treatment:

Behavioral: High-intensity physical exercise