Effects of High-intensity Exercise Training on Physical Fitness, Cognition, Language in Post-stroke Aphasia

Study Overview
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Brief Summary
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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: 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).

Official Title
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Exercising Language: Behavioral and Neurophysiological Changes After High-intensity Exercise Training in Post-stroke Aphasia

Conditions
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Aphasia, Acquired, Aphasia, Aphasia, Fluent, Aphasia Non Fluent

Intervention / Treatment
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* Behavioral: Low-intensity physical exercise
* Behavioral: High-intensity physical exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: As this is a feasibility study, participants can choose to participate in just one or both types of physical exercise interventions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low-intensity physical exercise<br>The participants will participate in a low-intensity non-aerobic exercise program for 2 weeks. | Behavioral: Low-intensity physical exercise<br>* 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.<br>|
| Experimental: High-intensity physical exercise<br>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. | Behavioral: High-intensity physical exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aphasia, physical exercise, high intensity interval training, cognition, physical fitness, balance