Evidence map›Paper›PMID 34016037›Full record

Trial reportBMC geriatrics2021

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

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC geriatrics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03545347 (Preliminary Effect and Safety of Physiotherapy With Strength Training and Protein-rich Nutritional Supplement in Combination With Anabolic Steroids in Cross-continuum Rehabilitation of Patients With Hip Fracture - a Randomized Controlled Pilot Trial.), which is not on this map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03545347 phase2completednot on this map

Preliminary Effect and Safety of Physiotherapy With Strength Training and Protein-rich Nutritional Supplement in Combination With Anabolic Steroids in Cross-continuum Rehabilitation of Patients With Hip Fracture - a Randomized Controlled Pilot Trial. (The HIP-SAP Trial)

TypeinterventionalSponsorMorten Tange Kristensen PT, PhDRan2018 to 2020Enrolled29ConditionsHip FracturesArmsNandrolone Decanoate, Protein-rich nutritional supplement, Physical therapy, Sodium Chloride 9mg/ml Injection
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Anabolic-steroid therapy after geriatric proximal femur fracture: a level I evidence systematic review and meta-analysis of bone density, functional recovery, and safety.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026
    Pooled it
  2. Anabolic Androgenic Steroids in Orthopaedic Surgery: Current Concepts and Clinical Applications.Journal of the American Academy of Orthopaedic Surgeons. Global research & reviews · 2022
    Pooled it
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Signe HulsbækPhysical Medicine and Rehabilitation Research - Copenhagen (PMR-C), Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital, Hvidovre, Denmark. s_hulsbaek@hotmail.com.
Thomas BandholmPhysical Medicine and Rehabilitation Research - Copenhagen (PMR-C), Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital, Hvidovre, Denmark.
Ilija BanDepartment of Orthopedic Surgery, Copenhagen University Hospital, Hvidovre, Denmark.
Nicolai Bang FossDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Jens-Erik Beck JensenDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Henrik KehletSection for Surgical Pathophysiology 7621, Copenhagen University Hospital, Copenhagen Ø, Denmark.
Morten Tange KristensenPhysical Medicine and Rehabilitation Research - Copenhagen (PMR-C), Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital, Hvidovre, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 .

Indexed as

Hip FracturesResistance TrainingAgedFeasibility StudiesFemaleHumansMalePilot ProjectsTestosterone CongenersTestosterone CongenersAnabolic steroidBody compositionHip fractureNutritional supplementPhysical functionPhysical therapyRehabilitationStrength training

Identifiers

PMID34016037
PMCPMC8136760

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.