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

Not Applicable

Active, not recruiting

• Conditions: Aphasia; Aphasia, Acquired; Aphasia Non Fluent; Aphasia, Fluent
• Interventions: Behavioral: Low-intensity physical exercise; Behavioral: High-intensity physical exercise

• Registration Number: NCT06185023
• Lead Sponsor: University of California, Berkeley

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-12
• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2023-12-14
• Study First Posted: 2023-12-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-intensity physical exercise	Low-intensity physical exercise	The participants will participate in a low-intensity non-aerobic exercise program for 2 weeks.
High-intensity physical exercise	High-intensity physical exercise	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).
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).
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 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 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.
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.

Trial Locations

Locations (4)

California State University East Bay; 🇺🇸 Hayward, California, United States

University of San Francisco; 🇺🇸 San Francisco, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

University of California Berkeley; 🇺🇸 Berkeley, California, United States