Evidence map›Paper›PMID 31870451›Full record

ArticleTrials2019

Preliminary effect and feasibility of physiotherapy with strength training and protein-rich nutritional supplement in combination with anabolic steroids in cross-continuum rehabilitation of patients with hip fracture: protocol for a blinded randomized controlled pilot trial (HIP-SAP1 trial).

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

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.1field-weighted citation impact, top 21% of its field
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

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. The impact of the frequency, duration and type of physiotherapy on discharge after hip fracture surgery: a secondary analysis of UK national linked audit data.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2022
    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

8 authors at 3 institutions in 1 country.

Signe HulsbækPhysical Medicine and Rehabilitation Research - Copenhagen (PMR-C), Department of Physiotherapy, Copenhagen University Hospital, Amager-Hvidovre, Kettegård Alle 30, 2650, Hvidovre, Denmark. s_hulsbaek@hotmail.com.ORCID http://orcid.org/0000-0002-6476-2819
Ilija BanDepartment of Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre, Kettegård Alle 30, 2650, Hvidovre, Denmark.
Tobias Kvanner AasvangDepartment of Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre, Kettegård Alle 30, 2650, Hvidovre, Denmark.
Jens-Erik Beck JensenDepartment of Endocrinology, Copenhagen University Hospital, Amager-Hvidovre, Kettegård Alle 30, 2650, Hvidovre, Denmark.
Henrik KehletSection for Surgical Pathophysiology 721, Copenhagen University Hospital, Rigshospitalet Ole Maaløes vej 26, 2100, Copenhagen Ø, Denmark.
Nicolai Bang FossDepartment of Anesthesiology, Copenhagen University Hospital, Amager-Hvidovre and Institute of Clinical Medicine, University of Copenhagen, Kettegård Alle 30, 2650, Hvidovre, Denmark.
Thomas BandholmPhysical Medicine and Rehabilitation Research - Copenhagen (PMR-C), Department of Physiotherapy, Copenhagen University Hospital, Amager-Hvidovre, Kettegård Alle 30, 2650, Hvidovre, Denmark.
Morten Tange KristensenPhysical Medicine and Rehabilitation Research - Copenhagen (PMR-C), Department of Physiotherapy, Copenhagen University Hospital, Amager-Hvidovre, Kettegård Alle 30, 2650, Hvidovre, Denmark.
Hvidovre Hospital · DKUniversity of Copenhagen · DKCopenhagen University Hospital · DK

Funding

The Capital Regions Cross-continuum Fund P-2017-1-07The Capital Regions Cross-continuum Fund P-2018-2-01The Capital Regions Research Fund for Health Research 2017-188
6 · The paper itself

Abstract

backgroundA 2014 Cochrane review evaluating the effect of anabolic steroids after hip fracture concluded that the quality of the studies was insufficient to draw conclusions on the effects and recommended further high-quality trials in the field. Therefore, the aim of this pilot trial is to determine the preliminary effect and feasibility of a 12-week multimodal intervention consisting of physiotherapy (with strength training), protein-rich nutritional supplement and anabolic steroid on knee-extension muscle strength and function 14 weeks after hip fracture surgery.

methodsWe plan to conduct a randomized, placebo-controlled pilot trial with 48 patients operated for acute hip fracture. The patients are randomized (1:1) to either (1) physiotherapy with protein-rich nutritional supplement plus anabolic steroid or (2) physiotherapy with protein-rich nutritional supplement plus placebo. Outcome assessments will be carried out blinded at baseline (3-10 days after surgery) and at 14 weeks after entering the trial. Primary outcome is the change from baseline to follow-up in maximal isometric knee-extension muscle strength in the fractured limb. Secondary outcomes are physical performance test, patient-reported outcomes, and measures of body composition. DISCUSSION: If the trial is found feasible and the results show an indication of anabolic steroid being a relevant addition to further enhance the recovery of muscle strength and function in an enhanced recovery after surgery program, this trial will constitute the basis of a larger confirmatory trial.

trial registrationClinicalTrials.gov, NCT03545347. Preregistered on 4 June 2018.

Indexed as

Dietary SupplementsMuscle StrengthPhysical Therapy ModalitiesAgedAnabolic AgentsDietary ProteinsFeasibility StudiesHip FracturesHumansMiddle AgedNandrolone DecanoateOrthopedic ProceduresPatient Reported Outcome MeasuresPhysical Functional PerformancePilot ProjectsQuadriceps MuscleAnabolic AgentsDietary ProteinsNandrolone DecanoateAnabolic steroidHip fractureNutritional supplementPhysiotherapyProteinRehabilitationStrength training

Identifiers

PMID31870451
PMCPMC6929304
OpenAlexW2997451345

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.