Effect of Participation in Virtual Exercise Sessions in Persons With Aphasia

Aphasia, Acquired Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05455463
• Other study ID #: CSUEB-IRB-2020-83
• Status: Completed
• Phase: N/A
• Start date: September 17, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: California State University, East Bay
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Presence of aphasia

• Able to join exercise classes over Zoom

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Acquired

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).

Locations

Country	Name	City	State
United States	California State University, East Bay	Hayward	California

Sponsors (1)

Lead Sponsor	Collaborator
California State University, East Bay

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sedentary behaviors	Change in sitting and sleeping time, as measured using activity monitor	Pre-intervention (week 0) and post intervention (week 10)
Other	Physical Activity: Steps	Change in steps per day, as measured using activity monitor	Pre-intervention (week 0) and post intervention (week 10)
Other	Physical Activity: Standing	Change in time spent standing, as measured using activity monitor	Pre-intervention (week 0) and post intervention (week 10)
Other	Engagement	Change in heart rate during exercise class, as measured using activity monitor	During intervention (weeks 1-10)
Other	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)
Other	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)
Other	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)
Primary	Adherence Rates	Percent of classes attended	During intervention (weeks 1-10)
Primary	Retention	Percent of participants completing the intervention	Post-intervention (week 10)
Secondary	Participants' attitudes towards the intervention	Acceptability and themes as identified via qualitative interview	Post-intervention (week 10)