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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Aphasia; Aphasia, Acquired; Aphasia Non Fluent; Aphasia, Fluent
• Intervention / Treatment: Behavioral: Low-intensity physical exercise; Behavioral: High-intensity physical exercise

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Ivanova, PhD; Phone Number: 4156389880; Email: ivanova@berkeley.edu

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94720
      • Recruiting
      • University of California Berkeley
      • Contact: Maria Ivanova, PhD; Phone Number: 415-638-9880; Email: ivanova@berkeley.edu
    • Hayward, California, United States, 94542
      • Recruiting
      • California State University East Bay
      • Contact: Michelle Gravier, PhD; Email: michelle.gravier@csueastbay.edu
    • San Francisco, California, United States, 94143
      • Not yet recruiting
      • University of California San Francisco
      • Contact: Cathra Halabi, MD; Email: Cathra.halabi@ucsf.edu
    • San Francisco, California, United States, 94118
      • Recruiting
      • University of San Francisco
      • Contact: Christian J Thompson, Ph.D.; Email: cjthompson@usfca.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
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.	Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
Changes on the Center for Epidemiological Studies Depression Scale (CES-D)	The 20-item self-rating questionnaire evaluates perceived mood and level of functioning within the past seven days. The scores range from 0-60. A score equal to or above 16 indicates a person at risk for clinical depression.	Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
Changes on the General Anxiety Disorder scale (GAD-7)	The 7-item self-report scale is used to identify anxiety based on problems experienced in the last two weeks. The scores range from 0-21, with higher scores indicative of more pronounced anxiety symptoms.	Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
Changes on the Pittsburgh Sleep Quality Index (PSQI)	The self-rating scale used to measure the quality and patterns of sleep. It differentiates "poor" from "good" sleep by measuring seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over the last month. The overall score ranges from 0-21, with higher scores indicative of more acute sleep disturbances.	Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
Changes on the Stroke and Aphasia Quality of Life Scale - 39 (SAQOL-39)	This questionnaire is specifically designed to assess quality of life in individuals with stroke and aphasia. The overall quality of life score can range from 1 to 5, with higher values indicating better quality of life and overall well-being.	Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)

Collaborators and Investigators

• Sponsor: University of California, Berkeley
• Collaborators: University of California, San Francisco; California State University, East Bay; University of San Francisco
• Investigators: Principal Investigator: Maria Ivanova, PhD, University of California, Berkeley

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: cognition; physical exercise; balance; high intensity interval training; aphasia; physical fitness
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia; Aphasia, Wernicke
• Other Study ID Numbers: 056427-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No