PMID- 38238172 OWN - NLM STAT- MEDLINE DCOM- 20240122 LR - 20240201 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 14 IP - 1 DP - 2024 Jan 18 TI - HIP fracture Supplemental Therapy to Enhance Recovery (HIPSTER): a protocol for a randomised controlled trial. PG - e079846 LID - 10.1136/bmjopen-2023-079846 [doi] LID - e079846 AB - INTRODUCTION: Hip fractures result in substantial health impacts for patients and costs to health systems. Many patients require prolonged hospital stays and up to 60% do not regain their prefracture level of mobility within 1 year. Physical rehabilitation plays a key role in regaining physical function and independence; however, there are no recommendations regarding the optimal intensity. This study aims to compare the clinical efficacy and cost-effectiveness of early intensive in-hospital physiotherapy compared with usual care in patients who have had surgery following a hip fracture. METHODS AND ANALYSIS: This two-arm randomised, controlled, assessor-blinded trial will recruit 620 participants who have had surgery following a hip fracture from eight hospitals. Participants will be randomised 1:1 to receive usual care (physiotherapy according to usual practice at the site) or intensive physiotherapy in the hospital over the first 7 days following surgery (two additional sessions per day, one delivered by a physiotherapist and the other by an allied health assistant). The primary outcome is the total hospital length of stay, measured from the date of hospital admission to the date of hospital discharge, including both acute and subacute hospital days. Secondary outcomes are functional mobility, health-related quality of life, concerns about falling, discharge destination, proportion of patients remaining in hospital at 30 days, return to preadmission mobility and residence at 120 days and adverse events. Twelve months of follow-up will capture data on healthcare utilisation. A cost-effectiveness evaluation will be undertaken, and a process evaluation will document barriers and facilitators to implementation. ETHICS AND DISSEMINATION: The Alfred Hospital Ethics Committee has approved this protocol. The trial findings will be published in peer-reviewed journals, submitted for presentation at conferences and disseminated to patients and carers. TRIAL REGISTRATION NUMBER: ACTRN12622001442796. CI - (c) Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Kimmel, Lara A AU - Kimmel LA AD - Department of Physiotherapy, Alfred Health, Melbourne, Victoria, Australia L.kimmel@alfred.org.au. AD - School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia. FAU - Raper, Eleanor AU - Raper E AUID- ORCID: 0009-0005-3162-5390 AD - Department of Physiotherapy, Alfred Health, Melbourne, Victoria, Australia. AD - Central Clinical School, Monash University, Melbourne, Victoria, Australia. FAU - Harris, Ian A AU - Harris IA AUID- ORCID: 0000-0003-0887-7627 AD - Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia. AD - School of Clinical Medicine, UNSW Medicine and Health, Sydney, New South Wales, Australia. FAU - Ackerman, Ilana N AU - Ackerman IN AUID- ORCID: 0000-0002-6028-1612 AD - School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia. FAU - Page, Richard AU - Page R AUID- ORCID: 0000-0002-2225-7144 AD - School of Medicine, Deakin University Faculty of Health, Geelong, Victoria, Australia. AD - Department of Orthopaedics, Barwon Health, Geelong, Victoria, Australia. AD - St John of God Geelong Hospital, Geelong, Victoria, Australia. FAU - Naylor, Justine M AU - Naylor JM AD - Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia. AD - School of Clinical Medicine, UNSW Medicine and Health, Sydney, New South Wales, Australia. FAU - Burge, Angela T AU - Burge AT AD - Department of Physiotherapy, Alfred Health, Melbourne, Victoria, Australia. AD - Central Clinical School, Monash University, Melbourne, Victoria, Australia. AD - Institute for Breathing and Sleep, Melbourne, Victoria, Australia. FAU - Hepworth, Graham AU - Hepworth G AD - Statistical Consulting Centre, The University of Melbourne, Melbourne, Victoria, Australia. FAU - Harris, Anthony AU - Harris A AUID- ORCID: 0000-0003-1641-3320 AD - Centre for Health Economics, Monash University, Melbourne, Victoria, Australia. FAU - Woode, Maame Esi AU - Woode ME AD - Centre for Health Economics, Monash University, Melbourne, Victoria, Australia. FAU - Gabbe, Belinda J AU - Gabbe BJ AD - School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia. FAU - Ekegren, Christina L AU - Ekegren CL AD - Rehabilitation, Ageing and Independent Living (RAIL) Research Centre, School of Primary and Allied Health Care, Monash University, Melbourne, Victoria, Australia. FAU - Holland, Anne E AU - Holland AE AD - Department of Physiotherapy, Alfred Health, Melbourne, Victoria, Australia. AD - Central Clinical School, Monash University, Melbourne, Victoria, Australia. AD - Institute for Breathing and Sleep, Melbourne, Victoria, Australia. LA - eng PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20240118 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 SB - IM MH - Humans MH - *Quality of Life MH - *Hip Fractures/surgery/rehabilitation MH - Physical Therapy Modalities MH - Treatment Outcome MH - Hospitalization MH - Randomized Controlled Trials as Topic PMC - PMC10806657 OTO - NOTNLM OT - aged OT - aged, 80 and over OT - hip OT - hospitalization OT - physical therapy modalities OT - rehabilitation medicine COIS- Competing interests: LK, ER, IAH, INA, RP, JMN, ATB and AEH declare grant funding from the Commonwealth of Australia Medical Research Future Fund paid to their institution for the conduct of the trial. EDAT- 2024/01/19 00:42 MHDA- 2024/01/22 06:42 PMCR- 2024/01/19 CRDT- 2024/01/18 21:54 PHST- 2024/01/22 06:42 [medline] PHST- 2024/01/19 00:42 [pubmed] PHST- 2024/01/18 21:54 [entrez] PHST- 2024/01/19 00:00 [pmc-release] AID - bmjopen-2023-079846 [pii] AID - 10.1136/bmjopen-2023-079846 [doi] PST - epublish SO - BMJ Open. 2024 Jan 18;14(1):e079846. doi: 10.1136/bmjopen-2023-079846.