Trial of high-intensity gait training and step monitoring for stroke

Abstract

Background: Physical inactivity in people with chronic stroke has a profound effect on daily function and increases the risk of devastating cardiovascular complications. Methods: We performed a multi-site assessor-blinded clinical trial involving 250 participants >6 months post-stroke who were randomly assigned to high-intensity walking training only (FAST), step activity monitoring only (SAM), or a combination protocol (FAST+SAM), for 12 weeks, with 2-3 sessions/week. FAST interventions included treadmill and overground walking while maximizing time spent in a target heart rate range. SAM interventions included progressive daily stepping goals and motivational interviewing and advisement. The primary outcome was the change in steps per day, and key secondary outcomes were self-selected walking speed and the 6-minute walk test. Results: Among 250 randomized participants, average steps/day significantly increased from baseline in both the SAM (1548 + or - 269, p<0.001) and FAST+SAM groups (1305 + or - 281, p<0.001), but not in the FAST group (438 + or - 241, p=0.07). All three groups significantly improved endurance on the 6-minute walk test, but only FAST and FAST+SAM reached clinical significance. Conclusions: A step activity monitoring and motivational interviewing program successfully increased steps per day in individuals with chronic stroke. However, our step monitoring program alone did not lead to a clinically meaningful change in walking endurance, illustrating the importance of both step monitoring and walking capacity training to increase physical activity and prevent debilitating future complications in people with chronic stroke. (ClinicalTrials.gov number NCT02835313)

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

ClinicalTrials.gov number NCT02835313

Funding Statement

This study was funded by the National Institutes of Health, grant # NIH-R01HD086362

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:

Institutional Review Board of University of Delaware gave ethical approval for this work; Institutional Review Board of University of Pennsylvania gave ethical approval for this work; Institutional Review Board of Indiana University gave ethical approval for this work.

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

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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