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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)

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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 .

OriginalsprogEngelsk
Artikelnummer323
TidsskriftBMC Geriatrics
Vol/bind21
Udgave nummer1
Antal sider11
ISSN1471-2318
DOI
StatusUdgivet - 20 maj 2021

Bibliografisk note

Funding Information:
This work is supported by the Capital Regions Research Fund for Health Research (2017–188); The Capital Regions Cross-continuum Fund (P-2017-1-0, P-2018-2-01); and the Danish Physiotherapy Association (2017) and Copenhagen University Hospital Amager-Hvidovre (2019, 2019–839). None of the funding providers influenced the design of the study, data collection, analysis, interpretation of data or writing the manuscript.

ID: 65734936