Impact of a low-threshold exercise and protein supplementation intervention to optimise physical function and target frailty in people experiencing homelessness and addiction: The LEAP II trial.

Abstract

Objective: Frailty is a state of physiological vulnerability and associated with adverse outcomes. People experiencing homelessness and addiction have a higher burden of frailty than the general population. This study’s aim was to test the feasibility and impact of an exercise intervention with protein supplementation to target low physical functioning and frailty in this population, which was flexibly delivered over 12 weeks, with exercise options three days per week. Methods: The primary outcome of feasibility was measured by recruitment, retention, adherence, acceptability and adverse events. Secondary outcomes were physical function, pain, frailty and nutritional status, and self-reported health. Results:  Forty-three participants enrolled. Overall retention was 69.8%, with higher retention observed in subgroups (women and older adults). Programme adherence and acceptability was reported in 93% and 100% of participants, respectively. No adverse events occurred. At baseline, sub-normative values were demonstrated for limb strength and balance; pain was prevalent in 34.8%; 23% had poor nutritional health between 32.5% and 72.1% lived with some degree of frailty. Significant improvements were demonstrated for lower limb strength, gait speed, pain, nutritional status and frailty, (p<0.05). Conclusions: This novel intervention delivered to this hard-to-reach population was shown to be feasible and impactful, indicating proof of concept.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

Clinical Trials.gov: NCT05700305

Clinical Protocols

https://doi.org/10.12688/hrbopenres.13678.1

Funding Statement

Yes

Author Declarations

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

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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 Faculty of Health Sciences REC at Trinity College Dublin (Ethical Approval Reference Number: 211202).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the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

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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).

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Data Availability

The data underlying this article cannot be shared publicly for the privacy of individuals that participated in this study. The data will be shared on reasonable request to the corresponding author.

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