Background: Slip, trips, and falls are a common cause of injury in older adults; limiting physical activity participation and mobility task performance. These injuries may result in preclinical mobility limitation (PCML), a period in which individuals report modifications but not difficulty in mobility tasks. Individuals with PCML are at risk of functional decline which can be prevented with exercise. High-intensity functional strength training (HIFST) involves short intervals of hard interspersed with easy exercise that may be a time efficient strategy to improve functioning for older adults experiencing PCML. Objective: This protocol outlines the rationale, methods, and planned analyses for a pilot randomized controlled trial and qualitative description (QD) to investigate the feasibility, preliminary effects, and acceptability of a home-based 12-week HIFST intervention for community-dwelling older adults (≥ 55 years) with PCML who have had an injury from a slip, trip, or fall. Methods: Twenty-four participants (target) will be randomized into a 12-week home-based HIFST or lower extremity stretching intervention. Feasibility will be determined using criteria for adherence, recruitment, retention, and safety and results will be presented using descriptive statistics. Preliminary effects on physical functioning, cognitive functioning, enjoyment, and harms will be assessed and presented as mean between-group differences with 95% confidence intervals. HIFST participants will be recruited for follow-up interviews using QD methodology to investigate the acceptability of the intervention. The results of this pilot trial will provide essential information for future research regarding the process, resources, and scientific merit of conducting home-based high-intensity exercise in a post-injury older adult population. Trial Registration: NCT05266911 Keywords: pilot study; mobility limitation; high-intensity exercise; older adults; tele-rehabilitation
Competing Interest StatementThe authors have declared no competing interest.
Clinical TrialNCT05266911
Funding StatementThis study did not received any funding.
Author DeclarationsI 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:
Hamilton Integrated Research Ethics Board gave ethical approval for this work (project #13879).
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 and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.
Yes
Data Availabilitynot applicable (protocol)
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