Aphasia, Aphasia, Acquired, Aphasia, Fluent, Aphasia Following Cerebral Infarction, Aphasia Following Nontraumatic Intracerebral Hemorrhage, Aphasia, Non-fluent
Conditions
Keywords
aphasia, physical exercise, high intensity interval training, cognition, physical fitness, balance, stroke, language
Brief summary
The goal of this clinical trial is to evaluate the effects of a high-intensity exercise program on recovery in individuals with post-stroke aphasia. The high-intensity exercise program has been specifically designed for individuals with post-stroke aphasia and includes an interval training full-body workout, which can increase cardiovascular fitness, improve muscle strength and motor performance, and maximize cognitive and language gains. The main question this study aims to answer is: • Does participation in a high-intensity exercise program lead to changes in physical health, language, cognitive, motor recovery, psychological and/or psychosocial domains? Participants will be randomly assigned to either a high-intensity exercise program (target intervention) or a low-intensity exercise program (control intervention) delivered over 12-weeks in a group setting. Outcome measures will be collected once immediately after the intervention period and once during the following 12-week maintenance period to capture short- and long-term effects of the exercise program.
Interventions
BEHAVIORALHigh-intensity physical exercise
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.
BEHAVIORALLow-intensity physical exercise
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 interaction, but without the intensity element, i.e., it will not incorporate the cardiovascular and the strengthening components.
Sponsors
University of California, Berkeley
University of California, San Francisco
California State University, East Bay
University of San Francisco
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants will be randomly assigned to the low intensity intervention (control intervention) or the high-intensity physical exercise intervention (target intervention).
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Aphasia following ischemic or hemorrhagic stroke * Aphasia as determined by a standardized language test (Western Aphasia Battery Aphasia Quotient \< 93.8 at study intake) * 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 patients' own primary care provider or other treating provider.
Exclusion criteria
* Prior history of dementia, neurologic illness (other than stroke), or recent (last 3 years) substance abuse * Significant visual or hearing disabilities (e.g., neglect, uncorrected visual or hearing loss) that interfere with testing * Self-report uncontrolled cardiorespiratory and/or metabolic disorders incompatible with exercise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change on the Western Aphasia Battery (WAB) - Aphasia Quotient | (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention. | 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
| Measure | Time frame | Description |
|---|---|---|
| Change on the WAB subtest scores | (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention. | The subtests from the Western Aphasia Battery (a standardized language test) measure different language capacities. Specifically, we will look at Spontaneous Speech, Fluency, Auditory Verbal Comprehension, Repetition, Naming and Word Finding subtest scores. |
| Change on the Curtiss-Yamada Comprehensive Language Evaluation - Revised (CYCLE-R) | (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention. | 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. |
| Changes on Category and Letter Verbal Fluency tasks | (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention. | Test of word retrieval and executive control abilities such as updating, shifting, and inhibiting. Participants are asked to name as many items as possible in 1 minute for a given category (e.g., clothes) and for a given letter (e.g., "s"). |
| Change on the Philadelphia Naming Test (PNT) | (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention. | Aphasia naming test to assess word retrieval abilities. The score ranges from 0 to 100, with a higher score indicating greater naming ability. |
| Changes on the California Cognitive Assessment Battery (CCAB) | (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention. | This is a computerized assessment battery of cognitive tasks that provides a comprehensive assessment of different cognitive domains. These tasks include computerized version of standard cognitive tasks such as Trail making test, Stroop test, Digit and Spatial Span tasks, Verbal learning tasks. These tasks will require participants to memorize lists of words, digits, describe pictures, and draw on the tablet. Participant's verbal and pointing responses will be recorded. The following tasks will be used: BAVLT Encoding, Digit Span Forward, Digit Span Reverse, Picture Matching, Spatial Span, Finger Tapping, BAVLT Delayed Recall, Continuous Picture Naming, Picture Description, Simple Reaction Time, Trails A, Trails B, Stroop, Design Fluency, Picture Description Delayed Recall, Verbal Fluency. |
| Changes in Maximal Aerobic Capacity | (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention. | 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 VO2 Max varies greatly depending on age, and for older participants is typically between 30-40ml/kg/min (higher values indicate greater fitness). |
| Change on the 2-minute Step Test | (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention. | 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) |
| Change on the 30-second chair stands | (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention. | The number of full stands from a seated position that can be completed in 30 seconds with arms folded across the chest. |
| Change on the Timed Up-and-Go Test | (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention. | The number of seconds it takes to get up from a seated position, walk 3 m, turn, and return to a seated position. |
| Change on the Functional Reach Test | (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention. | The number of inches reached forward with each arm with feet flat on the floor at hip width. |
| Change in Gait Speed | (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention. | The speed in meters per second for the middle 6 m of the 10 m walkway. |
Countries
United States
Contacts
CONTACTMaria Ivanova, PhD
PRINCIPAL_INVESTIGATORMaria Ivanova, PhD
University of California, Berkeley
Outcome results
None listed