Clinical trial NCT05455463: 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
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia, Acquired
Lead sponsor: California State University, East Bay
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Adherence Rates
timeFrame: During intervention (weeks 1-10)
measure: Retention
timeFrame: Post-intervention (week 10)
Secondary outcomes:
measure: Participants' attitudes towards the intervention
timeFrame: Post-intervention (week 10)
Other outcomes:
measure: Sedentary behaviors
timeFrame: Pre-intervention (week 0) and post intervention (week 10)
measure: Physical Activity: Steps
timeFrame: Pre-intervention (week 0) and post intervention (week 10)
measure: Physical Activity: Standing
timeFrame: Pre-intervention (week 0) and post intervention (week 10)
measure: Engagement
timeFrame: During intervention (weeks 1-10)
measure: Language ability
timeFrame: Pre-intervention (week 0) and post intervention (week 10)
measure: Quality of Life (perceived)
timeFrame: Pre-intervention (week 0) and post intervention (week 10)
measure: Cognition
timeFrame: Pre-intervention (week 0) and post intervention (week 10)
Locations:
city: Hayward
country: United States
facility: California State University, East Bay
state: California
Study officials:
affiliation: California State University, East Bay
name: Michelle 1 Gravier, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: