Effect of Participation in Virtual Exercise Sessions in Persons With Aphasia

Effect of Participation in Virtual Exercise Sessions on Physical Activity, Language and Cognitive Functioning, and Quality of Life in Persons With Aphasia

The purpose of this study is to test the feasibility and acceptability of an online exercise program for community-dwelling individuals with aphasia, a language disorder resulting from brain damage. Physical activity, language, cognitive, and quality of life outcomes will be collected to assess potential effectiveness.

Study Overview

• Status: Completed
• Conditions: Aphasia, Acquired
• Intervention / Treatment: Behavioral: Online aphasia-adapted physical activity class

Detailed Description

Approximately one-third of stroke survivors have aphasia, acquired language difficulty that affects the ability speak and understand others. However, despite documented benefits of interventions to promote physical activity (PA) after stroke, including improved health-related quality of life (QoL), social and emotional benefits, and improved cognition, individuals with aphasia are often excluded from this research due to their communication difficulties. This is particularly concerning, given that individuals with aphasia are at greater risk of social isolation and depression compared to stroke survivors without aphasia. Presently, limited research has been conducted that examines the effect of PA interventions in individuals with aphasia although preliminary findings suggest that benefits may exist across domains (health and disability).

This study aims to better understand how PA affects the lives of individuals with aphasia. Given weekly tele-instruction in PA over 10 weeks, participants' levels of PA will be monitored for the duration of the study. Pre- and post-treatment measures of cognitive ability, QoL, and aphasia severity will be collected and analyzed to characterize intervention effects. The results of this study will provide insight into whether PA may be an important component of future aphasia treatment.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Hayward, California, United States, 94542-3000
      • California State University, East Bay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Presence of aphasia
• Able to join exercise classes over Zoom

Exclusion Criteria:

• None

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
Experimental: Online aphasia-adapted physical activity class; Will receive the physical activity intervention.	Behavioral: Online aphasia-adapted physical activity class; Online 50-minute physical activity sessions, two to three times weekly for 10-11 weeks. The activity instructions will be modified to be aphasia-friendly (simplified language, multimodality support).
No Intervention: Usual routine control; Engage in physical activity per usual routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence Rates	Percent of classes attended	During intervention (weeks 1-10)
Retention	Percent of participants completing the intervention	Post-intervention (week 10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants' attitudes towards the intervention	Acceptability and themes as identified via qualitative interview	Post-intervention (week 10)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedentary behaviors	Change in sitting and sleeping time, as measured using activity monitor	Pre-intervention (week 0) and post intervention (week 10)
Physical Activity: Steps	Change in steps per day, as measured using activity monitor	Pre-intervention (week 0) and post intervention (week 10)
Physical Activity: Standing	Change in time spent standing, as measured using activity monitor	Pre-intervention (week 0) and post intervention (week 10)
Engagement	Change in heart rate during exercise class, as measured using activity monitor	During intervention (weeks 1-10)
Language ability	Change in Western Aphasia Battery-Revised Aphasia Quotient (minimum value:0, maximum value: 100, higher scores indicate a better outcome)	Pre-intervention (week 0) and post intervention (week 10)
Quality of Life (perceived)	Change in Burden of Stroke Scale Total Transformed Score; minimum value 0; maximum value 100; higher scores indicate worse outcome	Pre-intervention (week 0) and post intervention (week 10)
Cognition	Change in Test of Non-Verbal Intelligence Percentile Rank (minimum score: 0, maximum score 100, higher scores indicate a better outcome)	Pre-intervention (week 0) and post intervention (week 10)

Collaborators and Investigators

• Sponsor: California State University, East Bay
• Investigators: Principal Investigator: Michelle 1 Gravier, Ph.D., California State University, East Bay

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2020
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: CSUEB-IRB-2020-83

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be made available upon reasonable request
• IPD Sharing Time Frame: Data will become available at study conclusion and will be available for 7 years.
• IPD Sharing Access Criteria: Requests received by the primary investigator or other investigator team members via email will be reviewed for reasonable use
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

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