Feasibility and preliminary effect of anabolic steroids in addition to strength training and nutritional supplement in rehabilitation of patients with hip fracture: a randomized controlled pilot trial (HIP-SAP1 trial)

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

Abstract

Background: Anabolic steroid has been suggested as a supplement during hip fracture rehabilitation and a Cochrane Review recommended further trials. The aim was to determine feasibility and preliminary effect of a 12-week intervention consisting of anabolic steroid in addition to physiotherapy and nutritional supplement on knee-extension strength and function after hip fracture surgery.

Methods: Patients were randomized (1:1) during acute care to: 1. Anabolic steroid (Nandrolone Decanoate) or 2. Placebo (Saline). Both groups received identical physiotherapy (with strength training) and a nutritional supplement. Primary outcome was change in maximal isometric knee-extension strength from the week after surgery to 14 weeks. Secondary outcomes were physical performance, patient reported outcomes and body composition.

Results: Seven hundred seventeen patients were screened, and 23 randomised (mean age 73.4 years, 78% women). Target sample size was 48. Main limitations for inclusion were "not home-dwelling" (18%) and "cognitive dysfunction" (16%). Among eligible patients, the main reason for declining participation was "Overwhelmed and stressed by situation" (37%). Adherence to interventions was: Anabolic steroid 87%, exercise 91% and nutrition 61%. Addition of anabolic steroid showed a non-significant between-group difference in knee-extension strength in the fractured leg of 0.11 (95%CI -0.25;0.48) Nm/kg in favor of the anabolic group. Correspondingly, a non-significant between-group difference of 0.16 (95%CI -0.05;0.36) Nm/Kg was seen for the non-fractured leg. No significant between-group differences were identified for the secondary outcomes. Eighteen adverse reactions were identified (anabolic = 10, control = 8).

Conclusions: Early inclusion after hip fracture surgery to this trial seemed non-feasible, primarily due to slow recruitment. Although inconclusive, positive tendencies were seen for the addition of anabolic steroid.

Trial registration: Clinicaltrials.gov NCT03545347 .

Keywords: Anabolic steroid; Body composition; Hip fracture; Nutritional supplement; Physical function; Physical therapy; Rehabilitation; Strength training.

Conflict of interest statement

TB declares to have received speakers honoraria for talks or expert testimony on the efficacy of exercise therapy to enhance recovery after surgery at meetings or symposia held by biomedical companies (Zimmer Biomet and Novartis). All other authors declare that they have no competing interests. Sponsor, investigator, and others involved in the project are employed by Copenhagen University Hospital, Hvidovre, or Copenhagen University Hospital, Rigshospitalet, and they have no financial interest in the trial.

Figures

Fig. 1
Fig. 1
Participant flow chart

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