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StrokePA-ChatSNCT06679803

Feasibility of a First-Line Physical Activity Intervention After Stroke

A study testing Physical Activity Chats after Stroke (PA-ChatS) in people with Stroke and Ischemic Stroke, run by University of Minnesota at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Ischemic Stroke, Hemorrhagic Stroke
What is being tested?
Physical Activity Chats after Stroke (PA-ChatS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
5 Feb 2025to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stroke diagnosis confirmed by imaging
  • Admitted to Fairview Health System (Minnesota) at the time of study enrollment or discharged to a community-based setting from Fairview Health System within 3 months before study enrollment
  • Able and willing to participate fully in the study and provide informed consent or proxy consent with participant assent

Who cannot join

  • Discharge anticipated to a transitional care unit, skilled nursing facility, or other non-community-based care setting
  • Severe cognitive or communication impairments (inability to respond accurately to complete study screening questions or to provide informed consent or assent
  • Comorbid neurological disorder (Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis, dementia, Alzheimer's disease, Huntington's disease, glioblastoma, spinal cord injury, cerebral palsy)
  • Comorbid cancer, currently undergoing chemotherapy or radiation treatment
  • Received inpatient treatment or was hospitalized for psychiatric condition and/or alcohol or substance abuse within the past 12 months
  • Current diagnosis of a terimnal illness and/or receiving hospice care
Show all 11Show fewer
  • History of allergic reaction to adhesives that precludes the use of an adhesive necessary for adherence to activPAL measurement
  • Inability to speak, read, or understand English
  • Concurrent participation in another rehabilitation intervention research study
  • Resides more than 50 miles outside of the Twin Cities metropolitan area
  • Investigator discretion for safety or adherence reasons

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: PA-ChatS: Feasibility of Delivering a First-Line Physical Activity Intervention After Stroke

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.

Being tested
Physical Activity Chats after Stroke (PA-ChatS)
Keywords
physical activity, occupational therapy, behavioral intervention, stroke rehabilitation
Medical subject headings
Stroke, Ischemic Stroke, Hemorrhagic Stroke, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical Activity Chats after Stroke (PA-ChatS)Behavioural

    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 groups in NCT06679803
Study groupRoleWhat they receive
PA-ChatS InterventionExperimentalParticipants 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.
Receives: Behavioral: Physical Activity Chats after Stroke (PA-ChatS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to PA-ChatS sessions

    Percentage of participants who complete 6 out of 6 (100%) of PA-ChatS sessions. Session completion will be documented by the study intervention therapist and total count of sessions completed will be computed after the last intervention session is delivered.

    Measured: 6-weeks

  2. Adherence to wearable activity tracker

    Percentage of participants who use the wearable activity tracker (Fitbit Inspire 3) an average of 5 of 7 days/week during the 6-week intervention period. Data will be exported from Fitbit to compute average number of days per week the Fitbit was used.

    Measured: 6-weeks

Secondary outcomes (8)

  1. Acceptability of PA-ChatS Intervention

    The Client Satisfaction Questionnaire-8 will be used to measure acceptability of the intervention. This is an 8-item measure with each item rated on a 1 to 4-point Likert-type scale, and then averaged across all 8 items. A mean score of 3 or more indicates that the intervention is generally acceptable.

    Measured: Week 7

  2. Safety of the PA-ChatS intervention

    All participants will be queried regarding possible adverse events during the study at one time-point using an adverse events questionnaire previously administered in physical activity studies after stroke.

    Measured: Week 7

  3. Change in step count

    The activPAL micro4 will be used to measure step count, following a 24-hour, 7-day wear protocol.

    Measured: Weeks 1 to 12

  4. Change in sedentary time

    The activPAL micro4 will be used to measure sedentary time, following a 24-hour, 7-day wear protocol. Participants will complete a daily diary indicating the sleep time. Sleep will be removed following a diary-informed method.

    Measured: Weeks 1 to 12

  5. Adherence to step count

    The activPAL micro4 (24/7 wear protocol) will used to measure step count. The proportion of participants achieving 7500 or more steps per day will be reported.

    Measured: Week 24

  6. Adherence to sedentary time

    The activPAL micro4 (24/7 wear protocol) will used to measure sedentary time. Participants will complete a diary to indicate sleep time, and sleep will be removed following a diary-informed method. The proportion of participants achieving 7 hours or less of sedentary time per day will be reported.

    Measured: Week 24

  7. Adherence to moderate-to-vigorous physical activity

    The International Physical Activity Questionnaire will used to measure minutes per week of moderate-to vigorous-physical activity (MVPA). The proportion of participants achieving 90 minutes or more/week of MVPA will be reported.

    Measured: Week 24

  8. Adherence to strength training

    The Muscle-Strengthening Exercise Questionnaire Short Form will used to measure days per week of strength training. The proportion of participants achieving 2 or more days per week of strength training will be reported.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2024
  2. Study start5 Feb 2025
  3. Primary completion22 Jul 2026
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06679803
Sponsor's protocol ID
KIN-2024-33389
Other IDs
UM1TR004405
Acronym
PA-ChatS
Status last verified
Sep 2026
First submitted
5 Nov 2024
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data related to demographics, medical and stroke history, cognitive function, mobility, self-reported psychosocial and social support measures, and physical activity data may be requested.

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity Chats after Stroke (PA-ChatS) in people with Stroke and Ischemic Stroke, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to PA-ChatS sessions (time frame: 6-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06679803.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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