Exercising Language: Behavioral and Neurophysiological Changes After High-intensity Exercise Training in Post-stroke Aphasia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Locations
- 4
- Primary Endpoint
- Change on the Western Aphasia Battery (WAB) - Aphasia Quotient
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Behavioral)
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 (Behavioral)
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 (Behavioral)
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))
Investigators
Maria Ivanova
Assistant Professional Researcher
University of California, Berkeley