Physical Activity Intervention for Stroke

(PA-ChatS Trial)

Overseen By Emily Kringle, PhD, OTR/L

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Severe cognitive impairments, Neurological disorder, Cancer, Psychiatric condition, Terminal illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a new physical activity plan can assist individuals who have experienced a stroke. Participants will wear a Fitbit to track their steps and engage in weekly phone sessions with an occupational therapist for six weeks. They will also complete surveys to measure their activity levels over time. This trial suits individuals who have recently had a stroke, are receiving or have just completed care at Fairview Health System in Minnesota, and can fully participate in the study. As an unphased trial, it offers a unique opportunity for participants to contribute to innovative research that could enhance stroke recovery strategies.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this intervention is safe for stroke patients?

Research has shown that exercise programs for stroke patients, like the one in this study, are generally safe. Previous studies have examined the safety and practicality of these programs and found no major safety issues. Participants often use tools like wearable devices and mobile apps to assist with their exercise, which have been safely used in stroke recovery when guided by therapists.

In this study, participants track their steps with a Fitbit and have weekly phone calls with an occupational therapist. This method relies on strategies proven to aid stroke recovery safely. Overall, evidence suggests that these types of programs are well-tolerated and safe for people recovering from a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional stroke recovery treatments that often focus on medication and in-person therapy sessions, the Physical Activity Chats after Stroke (PA-ChatS) intervention is unique because it combines telehealth with wearable technology. Participants engage in weekly phone sessions with an occupational therapist, which makes the program more accessible and flexible compared to standard in-clinic visits. Additionally, the use of a Fitbit Inspire for self-monitoring step counts empowers patients to take an active role in their recovery by tracking their physical activity in real-time. Researchers are excited about this approach because it has the potential to enhance motivation and adherence to physical activity, crucial elements in stroke rehabilitation, without the need for frequent travel to a healthcare facility.

What evidence suggests that this physical activity intervention is effective for stroke recovery?

Research shows that physical activity can greatly improve brain function in people who have had a stroke. Studies have found that regular exercise after a stroke aids recovery and boosts brain health. In this trial, participants will receive the PA-ChatS Intervention, which includes tools like a Fitbit to count steps and collaboration with an occupational therapist. This support encourages stroke survivors to become more active, which is linked to better recovery. The PA-ChatS program promotes physical activity through regular conversations and tracking, potentially further aiding recovery after a stroke. ^{2 3 5 6 7}

Who Is on the Research Team?

Emily Kringle, PhD, OTR/L

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for individuals who have recently had a stroke and are within the first 6 weeks of recovery. Participants should be able to use a Fitbit and complete surveys, with regular meetings scheduled with an occupational therapist.

Inclusion Criteria

Admitted to Fairview Health System (Minnesota) at the time of study enrollment or discharged to a community-based setting from Fairview Health System within 10 days before study enrollment

I am willing and able to follow the study's requirements and give my consent.

My stroke was confirmed through a scan.

Exclusion Criteria

Inability to speak, read, or understand English

Resides more than 50 miles outside of the Twin Cities metropolitan area

Investigator discretion for safety or adherence reasons

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a physical activity intervention using a Fitbit Inspire and meet with an occupational therapist weekly for 6 weeks

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for physical activity levels and adherence to the intervention

18 weeks

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Physical Activity Chats after Stroke (PA-ChatS)

Trial Overview

The study tests a new program called PA-ChatS designed to encourage physical activity after stroke. It involves tracking steps with a Fitbit, weekly meetings with an occupational therapist, and completing surveys over six weeks.

How Is the Trial Designed?

Group I: PA-ChatS Intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

Eighteen randomized controlled trials were reviewed, revealing that interventions like aerobic and resistance training, electrical stimulation during walking, and robot-assisted arm therapy significantly increased physical activity in stroke patients.

Despite some effective interventions, the overall quality of evidence was low, and many studies showed no significant differences in physical activity, highlighting the need for more robust research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of interventions aimed at improving physical activity in individuals with stroke: a systematic review. Aguiar, LT., Nadeau, S., Martins, JC., et al.[2021]

Regular physical activity significantly benefits both primary and secondary stroke prevention by positively influencing various vascular risk factors such as obesity and hypertension.

After a stroke, tailored physical activity can help reduce the risk of recurrence, improve brain function, and enhance quality of life, but it must be adjusted based on individual health conditions and neurological impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Primary and Secondary Stroke Prevention: Physical Activity]. Padlina, G., Scutelnic, A., Salmen, S.[2021]

The Activate Physical Activity for Stroke pilot trial will evaluate the safety and feasibility of a multidisciplinary intervention designed to promote physical activity in 32 stroke patients undergoing rehabilitation, focusing on those who can walk at least 50 meters with assistance.

The primary outcomes will assess the safety of the intervention through monitoring adverse events and its feasibility by tracking retention and completion rates, with physical activity levels measured using a triaxial accelerometer as a secondary outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a multidisciplinary intervention to promote physical activity in patients with stroke undergoing rehabilitation: study protocol for the ActivePAS pilot randomised controlled trial. Kanai, M., Nozoe, M., Ohtsubo, T., et al.[2022]

A systematic review of 11 randomized controlled trials (RCTs) on home physical activity interventions for post-stroke patients revealed poor reporting quality, with only a median of 7 out of 39 CONSORT items fully reported.

Most studies relied on adherence diaries to assess physical activity, but there was a lack of objective adherence measurement methods, highlighting the need for improved reporting standards and more accurate assessment techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing adherence to physical activity programs post-stroke at home: A systematic review of randomized controlled trials. Lu, R., Lloyd-Randolfi, D., Jones, H., et al.[2021]

In a study of 200 patients with moderate to severe subacute stroke, those who underwent aerobic training experienced a higher rate of serious adverse events compared to those in the relaxation control group, with an incident rate ratio of 1.70.

The occurrence of serious adverse events in the aerobic training group was significantly influenced by pre-existing conditions such as diabetes mellitus and atrial fibrillation, indicating that these factors may increase risk and warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): Safety analyses of a randomized clinical trial. Rackoll, T., Nave, AH., Ebinger, M., et al.[2022]

This longitudinal observational study will track physical activity levels in stroke survivors for 2 years after rehabilitation discharge, aiming to understand how physical activity relates to cardiovascular risk factors and mobility.

The study will include 77 participants and measure various outcomes, such as moderate to vigorous physical activity and cardiovascular health, to identify factors influencing long-term physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the relationship between physical activity and cardiovascular risk factors in stroke survivors post completion of rehabilitation? Protocol for a longitudinal study. Fini, NA., Bernhardt, J., Holland, AE.[2022]

In a study of 186 stroke survivors, daily ambulatory activity (AA) increased during the subacute phase for those with mild to moderate disabilities, indicating that physical activity is crucial for recovery in this group.

Baseline levels of AA were significantly associated with better functional outcomes (measured by the modified Rankin scale) and quality of life (measured by EQ-5D-3L) at 6 months, highlighting the importance of monitoring and encouraging physical activity after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory activity in stroke survivors associated with functional outcome and quality of life: An observational cohort study. Kaffenberger, T., Bernhardt, J., Koehler, JL., et al.[2022]

Citations

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Physical Activity Intervention for Stroke (PA-ChatS Trial)

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This study is aimed to investigate how the ICF model can be integrated into the planning and implementation of personalized post-stroke programs, and evaluate ...

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The aim of this guideline is to provide a synopsis of best clinical practices in the rehabilitative care of adults recovering from stroke.

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