Feasibility of a First-Line Physical Activity Intervention After Stroke

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT06679803
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Physical Activity Chats after Stroke (PA-ChatS) — BEHAVIORAL
    PA-ChatS consists of (1) self-monitoring step count using a Fitbit Inspire, and (2) behavioral activation for stepping activity delivered via the telephone and guided by the PA-ChatS workbook. Participants will receive education regarding the physical activity after stroke, American Heart/Stroke Association guidelines for post-stroke physical activity levels, and an overview of the intervention activities. They will then use the Fitbit data to monitor average daily step counts, set a new step count goals (increasing by 5 to 10% of the daily average step count from the prior week), and create a specific plan for achieving the new step count goal. The interventionist will collaboratively problem solve with the participant to identify strategies to overcome barriers to stepping activity and maintain safety.

Study Details

The goal of this study is to explore a new intervention that supports physical activity within the first 6 weeks after stroke. All participants will complete assessments at weeks 0 and 7. During weeks 1 through 6, participants will use a Fitbit Inspire to track their step counts and meet with an occupational therapist one time per week. They will also complete weekly surveys. Physical activity levels will be measured using surveys and a wearable activPAL monitor 6 times during the study: Weeks 1, 3, 5, 7, 12, and 24.

Key Dates

Start date
Feb 5, 2025
Status verified
Feb 2026
Primary completion
Aug 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PA-ChatS Intervention
    Participants will receive 6, 20-30 minute intervention sessions delivered over the telephone by an occupational therapist over 6 weeks (1 session/week). They will also complete self-monitoring of step counts using a Fitbit Inspire.

Primary Outcome Measure

Adherence to PA-ChatS sessions [ Time Frame: 6-weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455-

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