Preliminary effect and feasibility of physiotherapy with strength training and protein-rich nutritional supplement in combination with anabolic steroids in cross-continuum rehabilitation of patients with hip fracture: protocol for a blinded randomized controlled pilot trial (HIP-SAP1 trial)

Signe Hulsbæk, Ilija Ban, Tobias Kvanner Aasvang, Jens-Erik Beck Jensen, Henrik Kehlet, Nicolai Bang Foss, Thomas Bandholm, Morten Tange Kristensen, Signe Hulsbæk, Ilija Ban, Tobias Kvanner Aasvang, Jens-Erik Beck Jensen, Henrik Kehlet, Nicolai Bang Foss, Thomas Bandholm, Morten Tange Kristensen

Abstract

Background: A 2014 Cochrane review evaluating the effect of anabolic steroids after hip fracture concluded that the quality of the studies was insufficient to draw conclusions on the effects and recommended further high-quality trials in the field. Therefore, the aim of this pilot trial is to determine the preliminary effect and feasibility of a 12-week multimodal intervention consisting of physiotherapy (with strength training), protein-rich nutritional supplement and anabolic steroid on knee-extension muscle strength and function 14 weeks after hip fracture surgery.

Methods: We plan to conduct a randomized, placebo-controlled pilot trial with 48 patients operated for acute hip fracture. The patients are randomized (1:1) to either (1) physiotherapy with protein-rich nutritional supplement plus anabolic steroid or (2) physiotherapy with protein-rich nutritional supplement plus placebo. Outcome assessments will be carried out blinded at baseline (3-10 days after surgery) and at 14 weeks after entering the trial. Primary outcome is the change from baseline to follow-up in maximal isometric knee-extension muscle strength in the fractured limb. Secondary outcomes are physical performance test, patient-reported outcomes, and measures of body composition.

Discussion: If the trial is found feasible and the results show an indication of anabolic steroid being a relevant addition to further enhance the recovery of muscle strength and function in an enhanced recovery after surgery program, this trial will constitute the basis of a larger confirmatory trial.

Trial registration: ClinicalTrials.gov, NCT03545347. Preregistered on 4 June 2018.

Keywords: Anabolic steroid; Hip fracture; Nutritional supplement; Physiotherapy; Protein; Rehabilitation; Strength training.

Conflict of interest statement

The authors declare that they have no competing interests.

Sponsor, investigator, and others involved in the project are employed by Copenhagen University Hospital, Amager-Hvidovre, or Copenhagen University Hospital, Rigshospitalet, and they have no financial interest in the trial.

Figures

Fig. 1
Fig. 1
Flowchart of enrollment, randomization, and trial-related activities
Fig. 2
Fig. 2
Schedule for enrollment, intervention, and outcome assessments (SPIRIT)

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