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

NCT ID: NCT06185023

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-12

Study Completion Date

2025-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Aphasia, Acquired Aphasia Aphasia, Fluent Aphasia Non Fluent

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

As this is a feasibility study, participants can choose to participate in just one or both types of physical exercise interventions.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High-intensity physical exercise

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.

Group Type EXPERIMENTAL

High-intensity physical exercise

Intervention Type 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 - remote

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.

Group Type EXPERIMENTAL

High-intensity physical exercise

Intervention Type 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.

Low-intensity physical exercise

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

Group Type ACTIVE_COMPARATOR

Low-intensity physical exercise

Intervention Type 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.

Interventions

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

University of San Francisco

OTHER

Sponsor Role collaborator

California State University, East Bay

OTHER

Sponsor Role collaborator

University of California, Berkeley

OTHER

Sponsor Role lead

Responsible Party

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Maria Ivanova

Assistant Professional Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Ivanova, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Berkeley

Locations

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University of California Berkeley

Berkeley, California, United States

Site Status

California State University East Bay

Hayward, California, United States

Site Status

University of San Francisco

San Francisco, California, United States

Site Status

University of California San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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056427-002

Identifier Type: -

Identifier Source: org_study_id

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