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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| University of San Francisco | OTHER |
| California State University, East Bay | OTHER |
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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:
Participants can take part in two different physical exercise interventions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-intensity physical exercise | Active Comparator | The participants will participate in a low-intensity non-aerobic exercise program for 2 weeks. |
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| High-intensity physical exercise | Experimental | 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. |
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| High-intensity physical exercise - remote | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Ivanova, PhD | University of California, Berkeley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Berkeley | Berkeley | California | 94720 | United States | ||
| California State University East Bay |
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As this is a feasibility study, participants can choose to participate in just one or both types of physical exercise interventions.
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| 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. |
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| Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Change on the Modified Rankin Scale (MRS) | 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. | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) |
| Changes on the National Institute of Health Stroke Scale (NIHSS) | 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. | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) |
| Changes on the Fugl-Meyer Assessment, Upper Extremity portion (FMA-UE) | 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. | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) |
| Hayward |
| California |
| 94542 |
| United States |
| University of San Francisco | San Francisco | California | 94118 | United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| ID | Term |
|---|---|
| D001037 | Aphasia |
| D001041 | Aphasia, Wernicke |
| D001039 | Aphasia, Broca |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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