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Clinical Trials/NCT06185023
NCT06185023
Completed
Not Applicable

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

University of California, Berkeley4 sites in 1 country12 target enrollmentDecember 11, 2023

Overview

Phase
Not Applicable
Intervention
Low-intensity physical exercise
Conditions
Aphasia, Acquired
Sponsor
University of California, Berkeley
Enrollment
12
Locations
4
Primary Endpoint
Change on the Western Aphasia Battery (WAB) - Aphasia Quotient
Status
Completed
Last Updated
2 months ago

Overview

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).
Registry
clinicaltrials.gov
Start Date
December 11, 2023
End Date
January 15, 2026
Last Updated
2 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maria Ivanova

Assistant Professional Researcher

University of California, Berkeley

Eligibility Criteria

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.

Arms & Interventions

Low-intensity physical exercise

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

Intervention: Low-intensity physical exercise

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.

Intervention: High-intensity physical exercise

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.

Intervention: High-intensity physical exercise

Outcomes

Primary Outcomes

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

  • 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))
  • 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))
  • 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))
  • Attendance(After the intervention (3rd week for the control intervention and 9th week for the experimental intervention))
  • 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))
  • Change in Gait Speed(Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm))
  • Change on the Functional Reach Test(Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm))

Study Sites (4)

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