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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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). / Hulsbæk, Signe; Bandholm, Thomas; Ban, Ilija; Foss, Nicolai Bang; Jensen, Jens Erik Beck; Kehlet, Henrik; Kristensen, Morten Tange.
I: BMC Geriatrics, Bind 21, Nr. 1, 323, 2021.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Feasibility and preliminary effect of anabolic steroids in addition to strength training and nutritional supplement in rehabilitation of patients with hip fracture
T2 - a randomized controlled pilot trial (HIP-SAP1 trial)
AU - Hulsbæk, Signe
AU - Bandholm, Thomas
AU - Ban, Ilija
AU - Foss, Nicolai Bang
AU - Jensen, Jens Erik Beck
AU - Kehlet, Henrik
AU - Kristensen, Morten Tange
N1 - Publisher Copyright: © 2021, The Author(s).
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - Anabolic steroid
KW - Body composition
KW - Hip fracture
KW - Nutritional supplement
KW - Physical function
KW - Physical therapy
KW - Rehabilitation
KW - Strength training
U2 - 10.1186/s12877-021-02273-z
DO - 10.1186/s12877-021-02273-z
M3 - Journal article
C2 - 34016037
AN - SCOPUS:85106641291
VL - 21
JO - B M C Geriatrics
JF - B M C Geriatrics
SN - 1471-2318
IS - 1
M1 - 323
ER -
ID: 272027517