Comparative effectiveness of fragility fracture integrated rehabilitation management for elderly individuals after hip fracture surgery: A study protocol for a multicenter randomized controlled trial

Medicine
Sang Yoon LeeFragility Fracture Rehabilitation Study Group

Abstract

Although it is essential to provide comprehensive rehabilitation after hip fracture to restore the patient to preoperative physical functioning, feasibility issues remain. Here, we describe a protocol for a randomized controlled trial (RCT) to evaluate the effectiveness of fragility fracture integrated rehabilitation management (FIRM) for elderly individuals after hip fracture surgery. We also examine the feasibility of applying FIRM in a chronic-care hospital or community-based setting. Elderly patients will be randomly assigned to either the FIRM, conventional, or control group for a 2-week intervention period following hip fracture surgery. The primary outcome of this study is Koval walking ability. All functional outcomes will be measured 1 and 3 weeks, 3, 6, and 12 months after the surgical intervention. Researchers will be blind to group allocation, and participants will be blind to outcome. A sample size of 282 participants will be necessary to demonstrate the effect of the FIRM program. After the RCT has been conducted in 3 core hospitals, FIRM will be applied in 6 community-based local hospitals to investigate the feasibility of the program. The data will be analyzed using the intention-to-treat principle. NCT03430193.

Associated Clinical Trials

References

Jan 1, 1990·International Disability Studies·F M CollenC M Bradshaw
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Nov 1, 2011·International Journal of Surgery·David MoherUNKNOWN CONSORT
Sep 11, 2012·The Journals of Gerontology. Series A, Biological Sciences and Medical Sciences·Yea-Ing L ShyuChing-Yen Chen
Feb 18, 2015·Journal of the American Medical Directors Association·Johanna EdgrenSarianna Sipilä
Mar 10, 2016·Archives of Osteoporosis·Boris SobolevUNKNOWN Canadian Collaborative Study on Hip Fractures
Jul 9, 2016·BMC Musculoskeletal Disorders·Jan-Erik GjertsenLars Birger Engesæter
Nov 23, 2017·The New England Journal of Medicine·Mohit Bhandari, Marc Swiontkowski

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Citations

Mar 1, 2019·Annals of Geriatric Medicine and Research·Jae-Young Lim
Nov 13, 2021·The Cochrane Database of Systematic Reviews·Helen Hg HandollTerence P Finnegan

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Methods Mentioned

BETA
total hip arthroplasty

Clinical Trials Mentioned

NCT03430193

Software Mentioned

PASS
SPSS

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