Back to resultsEffect of Participation in Virtual Exercise Sessions in Persons With Aphasia
Primary Purpose
Aphasia, Acquired
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online aphasia-adapted physical activity class
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia, Acquired
Eligibility Criteria
Inclusion Criteria:
- Presence of aphasia
- Able to join exercise classes over Zoom
Exclusion Criteria:
- None
Sites / Locations
- California State University, East Bay
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Online aphasia-adapted physical activity class
Usual routine control
Arm Description
Will receive the physical activity intervention.
Engage in physical activity per usual routine.
Outcomes
Primary Outcome Measures
Adherence Rates
Percent of classes attended
Retention
Percent of participants completing the intervention
Secondary Outcome Measures
Participants' attitudes towards the intervention
Acceptability and themes as identified via qualitative interview
Full Information
NCT ID
NCT05455463
First Posted
June 30, 2022
Last Updated
August 3, 2023
Sponsor
California State University, East Bay
1. Study Identification
Unique Protocol Identification Number
NCT05455463
Brief Title
Effect of Participation in Virtual Exercise Sessions in Persons With Aphasia
Official Title
Effect of Participation in Virtual Exercise Sessions on Physical Activity, Language and Cognitive Functioning, and Quality of Life in Persons With Aphasia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 17, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California State University, East Bay
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Acquired
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Online aphasia-adapted physical activity class
Arm Type
Experimental
Arm Description
Will receive the physical activity intervention.
Arm Title
Usual routine control
Arm Type
No Intervention
Arm Description
Engage in physical activity per usual routine.
Intervention Type
Behavioral
Intervention Name(s)
Online aphasia-adapted physical activity class
Intervention Description
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 Outcome Measure Information:
Title
Adherence Rates
Description
Percent of classes attended
Time Frame
During intervention (weeks 1-10)
Title
Retention
Description
Percent of participants completing the intervention
Time Frame
Post-intervention (week 10)
Secondary Outcome Measure Information:
Title
Participants' attitudes towards the intervention
Description
Acceptability and themes as identified via qualitative interview
Time Frame
Post-intervention (week 10)
Other Pre-specified Outcome Measures:
Title
Sedentary behaviors
Description
Change in sitting and sleeping time, as measured using activity monitor
Time Frame
Pre-intervention (week 0) and post intervention (week 10)
Title
Physical Activity: Steps
Description
Change in steps per day, as measured using activity monitor
Time Frame
Pre-intervention (week 0) and post intervention (week 10)
Title
Physical Activity: Standing
Description
Change in time spent standing, as measured using activity monitor
Time Frame
Pre-intervention (week 0) and post intervention (week 10)
Title
Engagement
Description
Change in heart rate during exercise class, as measured using activity monitor
Time Frame
During intervention (weeks 1-10)
Title
Language ability
Description
Change in Western Aphasia Battery-Revised Aphasia Quotient (minimum value:0, maximum value: 100, higher scores indicate a better outcome)
Time Frame
Pre-intervention (week 0) and post intervention (week 10)
Title
Quality of Life (perceived)
Description
Change in Burden of Stroke Scale Total Transformed Score; minimum value 0; maximum value 100; higher scores indicate worse outcome
Time Frame
Pre-intervention (week 0) and post intervention (week 10)
Title
Cognition
Description
Change in Test of Non-Verbal Intelligence Percentile Rank (minimum score: 0, maximum score 100, higher scores indicate a better outcome)
Time Frame
Pre-intervention (week 0) and post intervention (week 10)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of aphasia
Able to join exercise classes over Zoom
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle 1 Gravier, Ph.D.
Organizational Affiliation
California State University, East Bay
Official's Role
Principal Investigator
Facility Information:
Facility Name
California State University, East Bay
City
Hayward
State/Province
California
ZIP/Postal Code
94542-3000
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Effect of Participation in Virtual Exercise Sessions in Persons With Aphasia
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