Aphasia Clinical Trial
Official title:
Exercising Language: Behavioral and Neurophysiological Changes After High-intensity Exercise Training 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).
Status | Recruiting |
Enrollment | 12 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - aphasia following left hemisphere 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California Berkeley | Berkeley | California |
United States | California State University East Bay | Hayward | California |
United States | University of California San Francisco | San Francisco | California |
United States | University of San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Berkeley | California State University, East Bay, University of California, San Francisco, University of San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change on the Philadelphia Naming Test (PNT) | Aphasia naming test to assess word retrieval abilities. The score ranges from 0 to 100, with a higher score indicating greater naming ability. | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) | |
Other | Change on the Curtiss-Yamada Comprehensive Language Evaluation - Revised (CYCLE-R) | 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. | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) | |
Other | Changes on the Center for Epidemiological Studies Depression Scale (CES-D) | 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. | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) | |
Other | Changes on the General Anxiety Disorder scale (GAD-7) | 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. | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) | |
Other | Changes on the Pittsburgh Sleep Quality Index (PSQI) | 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. | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) | |
Other | Changes on the Stroke and Aphasia Quality of Life Scale - 39 (SAQOL-39) | 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. | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) | |
Primary | 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 | Changes in Maximal Aerobic Capacity | 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). | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) | |
Secondary | Attendance | Total number of physical exercise classes attended during the intervention. | After the intervention (3rd week for the control intervention and 9th week for the experimental intervention) | |
Secondary | Change on the 30-second chair stands | The number of full stands from a seated position that can be completed in 30 seconds with arms folded across the chest. | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) | |
Secondary | Change on the 2-minute Step Test | 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). | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) | |
Secondary | Change on the Timed Up-and-Go Test | The number of seconds it takes to get up from a seated position, walk 3 m, turn, and return to a seated position. | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) | |
Secondary | Change on the Functional Reach Test | The number of inches reached forward with each arm with feet flat on the floor at hip width. | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) | |
Secondary | Change in Gait Speed | The speed in meters per second for the middle 6 m of the 10 m walkway. | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) |
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