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

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Physical Activity Chats after Stroke (PA-ChatS)?

Research shows that physical activity after a stroke can help with recovery and improve brain health. Various interventions, including aerobic and resistance training, have been effective in increasing physical activity in stroke patients, which suggests that treatments like PA-ChatS could be beneficial. ^{1 2 3 4 5}

Is physical activity intervention safe for stroke patients?

Research shows that physical activity interventions for stroke patients are generally safe. Studies have focused on safety and feasibility, with no major safety concerns reported, although individual risk factors should be considered. ^{1 6 7 8 9}

How is the PA-ChatS treatment different from other stroke treatments?

The PA-ChatS treatment is unique because it focuses on promoting physical activity through personalized chats, providing ongoing support after formal rehabilitation ends, which helps stroke survivors maintain their activity levels and improve recovery. ^{1 4 10 11 12}

Research Team

Emily Kringle, PhD, OTR/L

Principal Investigator

University of Minnesota

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Ambulatory activity in stroke survivors associated with functional outcome and quality of life: An observational cohort study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy of interventions aimed at improving physical activity in individuals with stroke: a systematic review. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The Impact of Physical Activity Before and After Stroke on Stroke Risk and Recovery: a Narrative Review. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Assessing adherence to physical activity programs post-stroke at home: A systematic review of randomized controlled trials. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): Safety analyses of a randomized clinical trial. [2022]

7. England 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Protocol and pilot study of a short message service-guided training after acute stroke/transient ischemic attack to increase walking capacity and physical activity. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

[Primary and Secondary Stroke Prevention: Physical Activity]. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Interventions to promote long-term participation in physical activity after stroke: a systematic review of the literature. [2022]

11. Sweden pubmed.ncbi.nlm.nih.gov

Levels of physical activity in acute stroke patients treated at a stroke unit: A prospective, observational study. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Keeping Active with Texting after Stroke (KATS): development of a text message intervention to promote physical activity and exercise after stroke. [2023]