Effect of Participation in Virtual Exercise Sessions in Persons With Aphasia

Sponsor
California State University, East Bay (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05455463
Collaborator
(none)
25
1
2
39.4
0.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Online aphasia-adapted physical activity class
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants who elect to take part in the exercise intervention will be assigned to the intervention group, while those who do not will be assigned to the control group.Participants who elect to take part in the exercise intervention will be assigned to the intervention group, while those who do not will be assigned to the control group.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Participation in Virtual Exercise Sessions on Physical Activity, Language and Cognitive Functioning, and Quality of Life in Persons With Aphasia
Actual Study Start Date :
Sep 17, 2020
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Adherence Rates [During intervention (weeks 1-10)]

    Percent of classes attended

  2. Retention [Post-intervention (week 10)]

    Percent of participants completing the intervention

Secondary Outcome Measures

  1. Participants' attitudes towards the intervention [Post-intervention (week 10)]

    Acceptability and themes as identified via qualitative interview

Other Outcome Measures

  1. Sedentary behaviors [Pre-intervention (week 0) and post intervention (week 10)]

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

  2. Physical Activity: Steps [Pre-intervention (week 0) and post intervention (week 10)]

    Change in steps per day, as measured using activity monitor

  3. Physical Activity: Standing [Pre-intervention (week 0) and post intervention (week 10)]

    Change in time spent standing, as measured using activity monitor

  4. Engagement [During intervention (weeks 1-10)]

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

  5. Language ability [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) [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Presence of aphasia

  • Able to join exercise classes over Zoom

Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 California State University, East Bay Hayward California United States 94542-3000

Sponsors and Collaborators

  • California State University, East Bay

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michelle Gravier, Assistant Professor, California State University, East Bay
ClinicalTrials.gov Identifier:
NCT05455463
Other Study ID Numbers:
  • CSUEB-IRB-2020-83
First Posted:
Jul 13, 2022
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2022