Cardiorespiratory exercise and self-management early after stroke to increase daily physical activity: results from a stepped-wedge cluster randomized trial

ABSTRACT

Trial design Stepped-wedge cluster superiority randomized controlled trial.

Objective This study aimed to determine if Promoting Optimal Physical Exercise for Life (PROPEL) program increases participation in physical activity up to six months post-discharge from stroke rehabilitation, compared to participation in group cardiorespiratory exercise (GCE) alone.

Methods People with sub-acute stroke participated in the PROPEL (n=107) or GCE (n=65) intervention phases. The primary outcome was adherence to physical activity guidelines over seven days at six months post-discharge from rehabilitation. Secondary outcomes were exercise self-efficacy (Short Self-Efficacy for Exercise scale), exercise-related beliefs and attitudes (Short Outcome Expectation for Exercise scale), and perceived barriers to physical activity (Barriers to Being Active Quiz).

Results Fifty seven participants (PROPEL, n=29; GCE, n=28) were included in the analysis. At six months post-discharge, 6/17 PROPEL participants and 9/22 GCE participants met the guidelines for intensity and duration of physical activity; the odds of meeting the physical activity guidelines did not differ between phases (p>0.84). PROPEL participants reported higher self-efficacy for exercise than GCE participants (p=0.0047).

Conclusions Participation in the PROPEL increases self-efficacy for exercise compared to GCE alone after stroke. However, increased self-efficacy for exercise did not increase the odds of meeting physical activity guidelines.

Trial registration NCT02951338

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT02951338

Clinical Protocols

https://bmjopen.bmj.com/content/7/6/e015843

Funding Statement

This study was supported by the Canadian Institutes of Health Research (PJT148906). AM held a New Investigator Award from the Canadian Institutes of Health Research (MSH141983). AT was supported by a personnel award from the Heart and Stroke Foundation, Ontario Provincial Office (CS I 7468). The funding source had no role in the design or execution of the study, analyses, or interpretation of the data or decision to submit results.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This study was approved by the research ethics boards of: (a) Hamilton Health Sciences, Hamilton, Ontario (approval number: 2274); (b) Sunnybrook Health Sciences Centre, Toronto, Ontario (approval number: 472-2016); (c) St. Joseph's Care Group, Thunder Bay, Ontario (approval number: 2016011); (d) University Health Network, Toronto, Ontario (approval number: 16-5916); (e) West Park Healthcare Centre, Toronto, Ontario (approval number not provided in the letter); (f) Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario (approval number: 2016139).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Footnotes

Funding: This study was supported by the Canadian Institutes of Health Research (PJT148906). AM held a New Investigator Award from the Canadian Institutes of Health Research (MSH141983). AT was supported by a personnel award from the Heart and Stroke Foundation, Ontario Provincial Office (CS I 7468). The funding source had no role in the design or execution of the study, analyses, or interpretation of the data or decision to submit results.

Declaration of interest: The authors report no conflicts of interest.

Data Availability

The participants of this study did not give consent for their data to be shared publicly, so supporting/raw data is not available.

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