Feasibility of the "Preventing functional decline in acutely hospitalized older patients (PREV_FUNC)" study-A three-armed randomized controlled pilot trial.

BACKGROUND: Recent studies indicate that in-hospital exercise can mitigate the risk of functional decline in acutely hospitalized older adults. However, there is a lack of studies that compare different types of exercise interventions. This feasibility study was conducted in preparation for a three-armed randomized controlled trial. The aim was to examine the process feasibility (in terms of recruitment and retention rate, intervention compliance and acceptability), and scientific feasibility (in terms of presence of adverse events, and trends with 95% confidence intervals of the outcome measures) of the trial. METHODS: Patients aged ≥75 years, were included from geriatric medical wards at three hospitals in Stockholm, Sweden. Participants in two groups received a specialized intervention program, i.e., Simple or Comprehensive exercise program, respectively and one group received usual care. Assessments were conducted at hospital admission and discharge, and data were analyzed with descriptive statistics. RESULTS: In the spring 2022, 63 patients met the inclusion criteria and 39 accepted to participate (recruitment rate: 61.9%). COVID-19 affected the inclusion period. A total of 33 participants completed the study (i.e., were assessed at baseline and discharge, retention rate: 84.6%). Participants in the Simple and the Comprehensive exercise programs performed 88.9% and 80% of the possible training sessions, respectively. Both interventions were accepted by the participants and no adverse events were reported. The intervention groups showed a higher median change from admission to discharge than the control group on the Short Physical Performance Battery, the main outcome measure of the trial. CONCLUSION: The result of this pilot study suggests that the trial design is feasible and potentially useful for preventing functional decline in acutely hospitalized older adults. A full-scale trial will, however, require some considerations with respect to routines and logistics. The trial was registered at ClinicalTrials.gov, 4 May 2022, registration number NCT05366075.

Study protocol for the 'preventing functional decline in acutely hospitalised older patients (PREV_FUNC)' study: effects of two multicomponent exercise programmes on physical function - a three-armed randomised controlled trial.

INTRODUCTION: Acutely hospitalised older patients often live with frailty and have an increased risk of impaired physical function. Previous studies suggest that exercise might mitigate the risk of physical impairment; however, further research is needed to compare the effect of different types of exercise interventions. In this paper, we report a protocol for a trial that aims to examine (1) if multicomponent exercise interventions (interventions that include both mobility and strengthening exercises) have effects on physical function compared with usual care in older adults and (2) if a comprehensive multicomponent exercise programme is more effective than a simple multicomponent exercise programme that only include walking and sit-to-stand exercises. METHODS AND ANALYSIS: This is a three-armed randomised controlled trial, with two intervention groups (comprehensive and simple exercise programme) and a control group receiving usual care. We will include 320 participants aged ≥75 years from geriatric medical departments of four hospitals in Stockholm, Sweden. Assessments will be conducted at hospital admission, discharge and 3 months thereafter concerning physical function (primary outcome), activities of daily living, health-related quality of life, sarcopenia and falls. The number of readmissions will be registered up to 1 year after discharge. Data will be analysed with linear mixed effects models, according to the intention-to-treat approach. ETHICS AND DISSEMINATION: Ethical approval for this trial has been granted by the Swedish Ethical Review Authority (approval number 2022-03032-01). Data collection will consider the information requirement, the requirement of consent, confidentiality obligations and the utilisation requirement. Trial findings will be disseminated through multiple channels, including scientific publications and conferences, and workshops with healthcare professionals and the public. TRIAL REGISTRATION NUMBER: NCT05366075.