Van Grootven Bastiaan, van Dijk Margreet, Islam Farah, Coucke Birgit, Fieuws Steffen, Van Pottelbergh Gijs, Flamaing Johan, Van Den Noortgate Nele, Velghe Anja, De Cock Anne-Marie, Gillain Sophie, Meeuwissen Joris, Bautmans Ivan, Beckwée David, de Saint-Hubert Marie, van Uffelen Jannique, Schoevaerdts Didier, Tournoy Jos, van Achterberg Theo
KU Leuven, Department of Public Health, Academic Centre for Nursing and Midwifery, Leuven, Belgium.
Public Health, Institute of Nursing Science, University of Basel, Basel, Switzerland.
Pilot Feasibility Stud. 2025 Jun 21;11(1):87. doi: 10.1186/s40814-025-01668-8.
Currently, there is insufficient evidence supporting geriatric home rehabilitation after hospital discharge. Some studies demonstrate a positive effect, but meta-analytic evidence demonstrates uncertainty on the magnitude of the expected effect. Yet, evidence from other populations indicates that home rehabilitation could also be an effective strategy for older persons. Therefore, we aim to evaluate the effectiveness of geriatric home rehabilitation in older persons discharged from the hospital with disability. Given the potential challenges in recruiting participants delivering the intervention, and executing other study procedures in a multi-centre study, we will first carry out a pilot study.
The pilot study will commence with an initial start-up phase at two centres: UZ Leuven and CHU UCL Namur, Belgium. Up to three participants per centre will be included to test the procedures and assessments, excluding randomisation and intervention delivery. The study then progresses to the full pilot phase to evaluate and confirm the feasibility of the proposed trial. This pilot study will take place at the same two centres. The pilot study aligns with the design of the envisioned full trial, i.e. a pragmatic, multicentre, individually randomised superiority trial. A 1 to 1 allocation ratio will be used for the pilot. A total of 24 participants from the two centres will be recruited to investigate the pilot study objectives. The pilot endpoints will be used to determine the feasibility of recruitment and study procedures including data collection, assessments and delivery of the intervention (a 6-week program consisting of exercise sessions 3 times per week, 45 min each). The results from the pilot study will be discussed within the pilot study steering group. Progression criteria will be reviewed to determine if the study progresses to a full trial, and which adaptations are needed.
In case of a successful pilot, the study will progress to a full trial. The ambition of the full trial is to recruit 333 participants across 8 centres in Belgium, and to investigate the effectiveness of home rehabilitation for older persons discharged from the hospital with disability.
Clinicaltrials.gov, NCT06404138 on 08 May 2024.
目前，支持出院后老年居家康复的证据不足。一些研究显示出积极效果，但荟萃分析证据表明预期效果的大小存在不确定性。然而，来自其他人群的证据表明，居家康复对老年人也可能是一种有效的策略。因此，我们旨在评估老年居家康复对残疾出院老年人的有效性。鉴于在多中心研究中招募参与者、实施干预措施以及执行其他研究程序可能面临的挑战，我们将首先开展一项试点研究。
试点研究将在比利时的鲁汶大学医院（UZ Leuven）和那慕尔大学中心医院（CHU UCL Namur）这两个中心的初始启动阶段开始。每个中心最多纳入三名参与者，以测试程序和评估方法，但不包括随机分组和干预措施的实施。然后，研究进入全面试点阶段，以评估并确认拟议试验的可行性。该试点研究将在相同的两个中心进行。试点研究与设想的全面试验设计一致，即一项务实的、多中心的、个体随机化的优效性试验。试点将采用1:1的分配比例。将从两个中心招募总共24名参与者，以研究试点研究的目标。试点终点将用于确定招募和研究程序的可行性，包括数据收集、评估以及干预措施的实施（一个为期6周的项目，每周进行3次锻炼课程，每次45分钟）。试点研究的结果将在试点研究指导小组内进行讨论。将审查进展标准，以确定研究是否推进至全面试验，以及需要进行哪些调整。
如果试点成功，研究将推进至全面试验。全面试验的目标是在比利时的8个中心招募333名参与者，并研究居家康复对残疾出院老年人的有效性。
Clinicaltrials.gov，NCT06404138，2024年5月8日。
