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Randomized Controlled Trial
. 2024 Jun 21;19(6):e0304570.
doi: 10.1371/journal.pone.0304570. eCollection 2024.

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

Linda Sandberg  1   2 , Anne-Marie Boström  3   4   5 , Maria Hagströmer  1   6 , Charlotte Lindgren  2 , Miia Kivipelto  3   4   7   8 , Christina Sandlund  1   6   9 , Anna-Karin Welmer  1   10   11
Affiliations
Randomized Controlled Trial

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

Linda Sandberg et al. PLoS One. .

Abstract

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.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Flowchart of the PREV_FUNC pilot trial.
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