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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
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.
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.
University of California, Berkeley
Berkeley, California, United States
RECRUITINGCalifornia State University, East Bay
Hayward, California, United States
RECRUITINGUniversity of San Francisco
San Francisco, California, United States
RECRUITINGUniversity of California, San Francisco
San Francisco, California, United States
RECRUITINGChange 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.
Time frame: (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.
Change on the WAB subtest scores
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.
Time frame: (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.
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.
Time frame: (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.
Changes on Category and Letter Verbal Fluency tasks
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").
Time frame: (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.
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.
Time frame: (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.
Changes on the California Cognitive Assessment Battery (CCAB)
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.
Time frame: (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.
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 VO2 Max varies greatly depending on age, and for older participants is typically between 30-40ml/kg/min (higher values indicate greater fitness).
Time frame: (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.
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)
Time frame: (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.
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.
Time frame: (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.
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.
Time frame: (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.
Change on the Functional Reach Test
The number of inches reached forward with each arm with feet flat on the floor at hip width.
Time frame: (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.
Change in Gait Speed
The speed in meters per second for the middle 6 m of the 10 m walkway.
Time frame: (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.
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