Evidence map›Paper›PMID 25563584›Full record

Trial reportTrials2015

Early exercise after spinal cord injury ('Switch-On'): study protocol for a randomised controlled trial.

Mary P Galea, Sarah A Dunlop, Ruth Marshall, Jillian Clark, Leonid Churilov

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.3field-weighted citation impact, top 20% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
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

5 authors at 4 institutions in 1 country.

Mary P GaleaDepartment of Medicine (Royal Melbourne Hospital), The University of Melbourne, Parkville, VIC 3010, Australia. m.galea@unimelb.edu.au.
Sarah A Dunlop
Ruth Marshall
Jillian Clark
Leonid Churilov
Royal Rehabilitation Centre · AUFlorey Institute of Neuroscience and Mental Health · AUThe Royal Melbourne Hospital · AUUniversity of Western Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSpinal cord injury (SCI) leads to a profound muscular atrophy, bone loss and bone fragility. While there is evidence that exercising paralysed muscles may lead to reversal of muscle atrophy in the chronic period after SCI, there is little evidence that exercise can prevent muscle changes early after injury. Moreover, whether exercise can prevent bone loss and microarchitectural decay is not clear. METHODS/

designA multi-centre, parallel group, assessor-blinded randomised controlled trial will be conducted. Fifty participants with acute spinal cord injury will be recruited from four SCI units in Australia and New Zealand. Participants will be stratified by site and AIS status and randomised to an experimental or control group. Experimental participants will receive a 12-week programme of functional electrical stimulation (FES)-assisted cycling. Control participants will receive a 12-week programme of passive cycling. The primary outcome is muscle cross-sectional area of the thigh and calf measured using magnetic resonance images (MRI) of the leg. Secondary outcomes include serum biomarkers of SCI osteoporosis (sclerostin, P1NP and β-CTX), markers of immune function (IL-6, IL-10, FGF2, INF-γ, TNF-α), neurological function, body composition, depression and quality of life. Leg MRIs will be measured by a single blinded assessor based in Melbourne. Serum samples will be analysed in a central laboratory. All other characteristics will be measured at baseline and 12 weeks by blinded and trained assessors at each site. The first participant was randomised on 27 November 2012. DISCUSSION: The results of this trial will determine the relative effectiveness of a 12-week programme of FES-assisted cycling versus passive cycling in preventing muscle atrophy and maintaining skeletal integrity after spinal cord injury.

trial registrationACTRN12611001079932 (18 October 2011).

Indexed as

BicyclingElectric Stimulation TherapyResearch DesignAustraliaBiomarkersClinical ProtocolsExercise TherapyHumansLower ExtremityMagnetic Resonance ImagingMuscle, SkeletalMuscular AtrophyNew ZealandOsteoporosisQuality of LifeRecovery of FunctionBiomarkers

Identifiers

PMID25563584
PMCPMC4320571
OpenAlexW2098112326

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.