Effect of Participation in Virtual Exercise Sessions in Persons With Aphasia

NCT05455463 | Completed

• 1 other identifier: CSUEB-IRB-2020-83
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia, Acquired

Outcome Measures

Primary Outcomes (2)

• Adherence Rates

  Percent of classes attended

  During intervention (weeks 1-10)

• Retention

  Percent of participants completing the intervention

  Post-intervention (week 10)

Secondary Outcomes (1)

• Participants' attitudes towards the intervention

  Post-intervention (week 10)

Other Outcomes (7)

• Sedentary behaviors

  Pre-intervention (week 0) and post intervention (week 10)

• Physical Activity: Steps

  Pre-intervention (week 0) and post intervention (week 10)

• Physical Activity: Standing

  Pre-intervention (week 0) and post intervention (week 10)

Study Arms (2)

Online aphasia-adapted physical activity class

EXPERIMENTAL

Will receive the physical activity intervention.

Behavioral: Online aphasia-adapted physical activity class

Usual routine control

NO INTERVENTION

Engage in physical activity per usual routine.

Interventions

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).

Online aphasia-adapted physical activity class

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• California State University, East Bay: lead

Study Sites (1)

California State University, East Bay

Hayward, California, 94542-3000, United States

Location

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

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

Study Officials

• Michelle 1 Gravier, Ph.D.

  California State University, East Bay

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 13, 2022
• Study Start: September 17, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available at study conclusion and will be available for 7 years.
• Access Criteria: Requests received by the primary investigator or other investigator team members via email will be reviewed for reasonable use

Locations

US (1)