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

NCT06185023 | Completed

• 1 other identifier: 056427-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

Aphasia; Aphasia, Fluent; Aphasia Non Fluent; Aphasia, Acquired

Keywords

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

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.

  Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)

Secondary Outcomes (7)

• Changes in Maximal Aerobic Capacity

  Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)

• Attendance

  After the intervention (3rd week for the control intervention and 9th week for the experimental intervention)

• Change on the 30-second chair stands

  Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)

• Change on the 2-minute Step Test

  Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)

• Change on the Timed Up-and-Go Test

  Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)

Other Outcomes (9)

• Change on the Philadelphia Naming Test (PNT)

  Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)

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

  Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)

• Changes on the Center for Epidemiological Studies Depression Scale (CES-D)

  Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)

Study Arms (3)

Low-intensity physical exercise

ACTIVE COMPARATOR

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

Behavioral: Low-intensity physical exercise

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 8 weeks.

Behavioral: High-intensity physical exercise

High-intensity physical exercise - remote

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

Behavioral: High-intensity physical exercise

Interventions

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 exercises, but without the intensity element, i.e., it will not incorporate the cardiovascular and the strengthening components.

Low-intensity physical exercise

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; High-intensity physical exercise - remote

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: collaborator
• University of San Francisco: collaborator
• California State University, East Bay: collaborator
• University of California, Berkeley: lead

Study Sites (4)

University of California Berkeley

Berkeley, California, 94720, United States

Location

California State University East Bay

Hayward, California, 94542, United States

Location

University of San Francisco

San Francisco, California, 94118, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Aphasia; Aphasia, Wernicke; Aphasia, Broca; Motor Activity

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

Study Officials

• Maria Ivanova, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professional Researcher

Model Details: As this is a feasibility study, participants can choose to participate in just one or both types of physical exercise interventions.

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 29, 2023
• Study Start: December 11, 2023
• Primary Completion: September 12, 2025
• Study Completion: January 15, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)