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

Sang Yoon Lee, Jaewon Beom, Bo Ryun Kim, Seung-Kyu Lim, Jae-Young Lim, Fragility Fracture Rehabilitation Study Group, Sang Yoon Lee, Jaewon Beom, Bo Ryun Kim, Seung-Kyu Lim, Jae-Young Lim, Fragility Fracture Rehabilitation Study Group

Abstract

Introduction: 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.

Methods and analysis: 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.

Trial registration number: NCT03430193.

Figures

Figure 1
Figure 1
Trial procedure flow diagram.

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