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Completed

NCT Number: NCT05455463

Effect of Participation in Virtual Exercise Sessions 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.

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Key information

Conditions

Aphasia, Acquired Aphasia Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California State University, East Bay

Hayward, California, 94542-3000, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Online aphasia-adapted physical activity class

Behavioral

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).

Primary outcomes

  1. Adherence Rates

    Time frame: During intervention (weeks 1-10)

    Percent of classes attended

  2. Retention

    Time frame: Post-intervention (week 10)

    Percent of participants completing the intervention

Secondary outcomes

  1. Participants' attitudes towards the intervention

    Time frame: Post-intervention (week 10)

    Acceptability and themes as identified via qualitative interview

Other outcomes

  1. Sedentary behaviors

    Time frame: Pre-intervention (week 0) and post intervention (week 10)

    Change in sitting and sleeping time, as measured using activity monitor

  2. Physical Activity: Steps

    Time frame: Pre-intervention (week 0) and post intervention (week 10)

    Change in steps per day, as measured using activity monitor

  3. Physical Activity: Standing

    Time frame: Pre-intervention (week 0) and post intervention (week 10)

    Change in time spent standing, as measured using activity monitor

  4. Engagement

    Time frame: During intervention (weeks 1-10)

    Change in heart rate during exercise class, as measured using activity monitor

  5. Language ability

    Time frame: Pre-intervention (week 0) and post intervention (week 10)

    Change in Western Aphasia Battery-Revised Aphasia Quotient (minimum value:0, maximum value: 100, higher scores indicate a better outcome)

  6. Quality of Life (perceived)

    Time frame: Pre-intervention (week 0) and post intervention (week 10)

    Change in Burden of Stroke Scale Total Transformed Score; minimum value 0; maximum value 100; higher scores indicate worse outcome

  7. Cognition

    Time frame: Pre-intervention (week 0) and post intervention (week 10)

    Change in Test of Non-Verbal Intelligence Percentile Rank (minimum score: 0, maximum score 100, higher scores indicate a better outcome)

Sponsors and collaborators

Lead sponsor

California State University, East Bay

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2022
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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