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

doi:10.1186/s12877-021-02273-z

Signe Hulsbæk, Morten Tange Kristensen + Show 5 more

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https://doi.org/10.1186/s12877-021-02273-z

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Abstract

BackgroundAnabolic 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.MethodsPatients 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.ResultsSeven 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).ConclusionsEarly 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 registrationClinicaltrials.gov NCT03545347.

Highlights

Patients with a hip fracture are a vulnerable group with high morbidity and mortality
Positive tendencies were seen for the addition of anabolic steroid
Based on existing knowledge on rehabilitation following hip fracture [12, 13, 15] and review recommendations [4, 9, 12, 17, 18], we investigated an early multimodal intervention consisting of anabolic steroid, nutritional supplement and exercise, to enhance short and long term outcomes after a hip fracture

Summary

Introduction

Patients with a hip fracture are a vulnerable group with high morbidity and mortality. Positive effects on mobility of structured exercise interventions including strength training are reported [12,13,14,15], these interventions alone are insufficient to overcome the major longterm negative impact of a hip fracture on physical function [7]. A Cochrane Review (2014) evaluated the effect of anabolic steroids in rehabilitation following hip fracture surgery on functional outcome and adverse events [18]. 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

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