Aphasia, Aphasia, Acquired, Aphasia, Fluent, Aphasia Non Fluent
Conditions
Keywords
aphasia, physical exercise, high intensity interval training, cognition, physical fitness, balance
Brief summary
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).
Interventions
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 exercises, but without the intensity element, i.e., it will not incorporate the cardiovascular and the strengthening components.
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.
Sponsors
University of California, Berkeley
University of California, San Francisco
University of San Francisco
California State University, East Bay
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
As this is a feasibility study, participants can choose to participate in just one or both types of physical exercise interventions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* aphasia following single or multiple 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change on the Western Aphasia Battery (WAB) - Aphasia Quotient | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) | 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 |
|---|---|---|
| Changes in Maximal Aerobic Capacity | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) | 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). |
| Attendance | After the intervention (3rd week for the control intervention and 9th week for the experimental intervention) | Total number of physical exercise classes attended during the intervention. |
| Change on the 30-second chair stands | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) | 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 2-minute Step Test | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) | 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 Timed Up-and-Go Test | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) | 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 | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) | The number of inches reached forward with each arm with feet flat on the floor at hip width. |
| Change in Gait Speed | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) | The speed in meters per second for the middle 6 m of the 10 m walkway. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMaria Ivanova, PhD
University of California, Berkeley
Outcome results
None listed