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Completed

NCT Number: NCT06185023

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

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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Berkeley, Berkeley, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change on the Western Aphasia Battery (WAB) - Aphasia Quotient

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

    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.

Secondary outcomes

  1. Changes in Maximal Aerobic Capacity

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

    This is a measure of cardiorespiratory and metabolic fitness. Maximal Aerobic Capacity (VO2 Max) is the ability of the body to utilize oxygen to produce energy and is measured via a graded exercise test until volitional fatigue, while measuring consumption of oxygen with a computerized metabolic system. Typically measured on a treadmill, VO2 Max has also been found to be accurately and safely measured in stroke survivors on a recumbent stepper, which will be used in this study. A good VO2max varies greatly depending on age, and for older participants is typically between 30-40 ml/kg/min (higher values indicate greater fitness).

  2. Attendance

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

    Total number of physical exercise classes attended during the intervention.

  3. Change on the 30-second chair stands

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

    The number of full stands from a seated position that can be completed in 30 seconds with arms folded across the chest.

  4. Change on the 2-minute Step Test

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

    The number of knee raises completed in 2 minutes, raising each knee to a point midway between the patella (kneecap) and iliac crest (top hip bone).

  5. Change on the Timed Up-and-Go Test

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

    The number of seconds it takes to get up from a seated position, walk 3 m, turn, and return to a seated position.

  6. Change on the Functional Reach Test

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

    The number of inches reached forward with each arm with feet flat on the floor at hip width.

  7. Change in Gait Speed

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

    The speed in meters per second for the middle 6 m of the 10 m walkway.

Other outcomes

  1. Change on the Philadelphia Naming Test (PNT)

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

    Aphasia naming test to assess word retrieval abilities. The score ranges from 0 to 100, with a higher score indicating greater naming ability.

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

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

    A sentence-to-picture matching tasks that evaluates comprehension of sentences of varying complexity. The scores range from 0 to 100%, with higher scores indicative of better comprehension abilities.

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

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

    The 20-item self-rating questionnaire evaluates perceived mood and level of functioning within the past seven days. The scores range from 0-60. A score equal to or above 16 indicates a person at risk for clinical depression.

  4. Changes on the General Anxiety Disorder scale (GAD-7)

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

    The 7-item self-report scale is used to identify anxiety based on problems experienced in the last two weeks. The scores range from 0-21, with higher scores indicative of more pronounced anxiety symptoms.

  5. Changes on the Pittsburgh Sleep Quality Index (PSQI)

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

    The self-rating scale used to measure the quality and patterns of sleep. It differentiates "poor" from "good" sleep by measuring seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over the last month. The overall score ranges from 0-21, with higher scores indicative of more acute sleep disturbances.

  6. Changes on the Stroke and Aphasia Quality of Life Scale - 39 (SAQOL-39)

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

    This questionnaire is specifically designed to assess quality of life in individuals with stroke and aphasia. The overall quality of life score can range from 1 to 5, with higher values indicating better quality of life and overall well-being.

  7. Change on the Modified Rankin Scale (MRS)

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

    This is a commonly used 7-point rating scale for measuring the degree of overall disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. MRS is a single item, global outcomes rating scale for patients post-stroke. The measure is scored based on a structured interview. It is used to categorize level of functional independence with reference to pre-stroke activities rather than on observed performance of a specific task. The scale ranges from 0 to 6, with higher scores indicative of more severe disability, with 6 indicating that the patient is dead.

  8. Changes on the National Institute of Health Stroke Scale (NIHSS)

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

    This is a widely used clinical scale for measuring impairment in various domains (consciousness, motor, sensory, attention, language) after stroke. It uses a numerical scale to determine stroke severity, health care providers record the person's performance in 11 categories, such as sensory and motor ability. Each domain is rated on a scale from 0 to 2 or 3/4 for certain domains), with 0 indicating no impairment. The total score can range from 0 to 42 points, with higher scores indicating greater severity.

  9. Changes on the Fugl-Meyer Assessment, Upper Extremity portion (FMA-UE)

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

    This is a commonly used outcome measure for assessment of sensorimotor recovery after stroke. We will only use the upper extremity portion of the assessment to supplement other study measures focusing on gait and balance. The FMA-UE assesses movement, coordination, and reflexes associated with the shoulder, elbow, forearm, wrist, and hand and is meant to capture stages of motor recovery after stroke. The FMA-UE consists of 33 items with each item scored on a 3-point ordinal scale (0, 1, or 2), with 0 generally corresponding to no function, 1 to partial function, and 2 to perfect function. The items are summed to provide a final score, ranging from 0-66 points, with lower scores indicative of more pronounced motor impairments of the upper extremity.

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Collaborators

  • California State University, East Bay
  • University of California, San Francisco
  • University of San Francisco

Registry information

Official study title

Exercising Language: Behavioral and Neurophysiological Changes After High-intensity Exercise Training in Post-stroke Aphasia

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 29, 2023
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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