Evidence map›Paper›PMID 29025830›Full record

Trial reportBMJ open2017

Randomised controlled pilot trial of an exercise plus behaviour change intervention in people with multiple sclerosis: the Step it Up study.

Sara Hayes, Marcin Kacper Uszynski, Robert W Motl, Stephen Gallagher, Aidan Larkin, John Newell, Carl Scarrott, Susan Coote

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02301442 (A Randomised Controlled Trial of an Exercise Plus Behaviour Change Intervention in People With MS), which is not on this map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
2.4field-weighted citation impact, top 11% 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.

NCT02301442 nacompletednot on this map

A Randomised Controlled Trial of an Exercise Plus Behaviour Change Intervention in People With MS: the "Step it Up" Study Protocol

TypeinterventionalSponsorUniversity of LimerickRan2014 to 2016Enrolled65ConditionsMultiple SclerosisArmsExercise + behaviour change intervention, Exercise + control education
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 3 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pooled it
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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 4 institutions in 3 countries.

Sara HayesDepartment of Clinical Therapies, Faculty of Education and Health Sciences, Health Research Institute, University of Limerick, Limerick, Ireland.
Marcin Kacper UszynskiDepartment of Clinical Therapies, Faculty of Education and Health Sciences, Health Research Institute, University of Limerick, Limerick, Ireland.
Robert W MotlDepartment of Physical Therapy, School of Health Professions, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Stephen GallagherDepartment of Psychology, Faculty of Education and Health Sciences, Centre for Social Issues Research, University of Limerick, Limerick, Ireland.
Aidan LarkinWestern Region, Multiple Sclerosis Society of Ireland, Dublin, Ireland.
John NewellHRB Clinical Research Facility and School of Mathematics, Statistics and Applied Mathematics, National University of Ireland, Galway, Ireland.
Carl ScarrottHRB Clinical Research Facility and School of Mathematics, Statistics and Applied Mathematics, National University of Ireland, Galway, Ireland.
Susan CooteDepartment of Clinical Therapies, Faculty of Education and Health Sciences, Health Research Institute, University of Limerick, Limerick, Ireland.ORCID http://orcid.org/0000-0001-7077-0164
University of Limerick · IENational University of Ireland · IEAmerican Physical Therapy Association · USMultiple Sclerosis Society of Ireland · IE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate feasibility of multiple sclerosis (MS) exercise guidelines for inactive people with MS (PwMS) and to examine preliminary efficacy for walking. To investigate effect of augmenting that intervention with education based on social cognitive theory (SCT).

designPilot multicentre, double-blind, randomised, parallel, controlled trial.

settingCommunity-delivered programme.

participantsSixty-five physically inactive PwMS walked independently, scored 0-3 on the Patient Determined Disease Steps Scale, had no MS relapse or change in MS medication in 12 weeks.

interventions10-week exercise plus SCT education (SCT) compared with exercise plus attention control education (CON). OUTCOME MEASURES: Six-Minute Walk Test (6MWT), Timed Up and Go (TUG) test and Multiple Sclerosis Walking Scale-12 (MSWS-12).

results174 expressed interest, 92 were eligible and 65 enrolled (SCT, n=32; CON, n=33). The intervention was feasible and delivered as intended. 68% of SCT group and 50% of control group met the exercise guidelines after intervention. Using linear mixed effects models, intention-to-treat basis, there was insufficient evidence for difference between the groups over the trial (6MWT, p=0.30; TUG, p=0.4; MSWS-12, p=0.8). Using secondary analysis of a cohort with data for≥3 assessments (SCT, n=21; CON, n=20), there was significant treatment effect favouring the intervention group (p=0.04) with mean effect for 6MWT 39.0 m (95% CI 2.26 to 75.73) at 12 weeks and 40.0 m (95% CI 2.3 to 77.8) at 36 weeks. Both groups improved significantly in 6MWT following 10-week intervention (SCT, mean ∆=83.02, SD=60.1, p≤0.01; CON, mean ∆=56.92, SD=73.5, p≤0.01), TUG (SCT, ∆=-0.70, SD=1.25, p≤0.01; CON, ∆=-0.54, SD=0.95, p≤0.01) and MSWS-12 (SCT, ∆=-8.03, SD=16.18, p=0.02; CON, ∆=-0.86, SD=18.74, p=0.81).

conclusionsA 10-week exercise programme based on the MS exercise guidelines for improving walking in previously inactive PwMS was feasible. There is marginal evidence of a treatment effect in favour of the exercise plus SCT intervention at 12 and 36 weeks. TRIAL REGISTRATION NUMBER: NCT02301442; Results.

Indexed as

Behavior TherapyExercise TherapyPatient Education as TopicAdultFemaleHumansMaleMiddle AgedMobility LimitationMultiple SclerosisPilot ProjectsPractice Guidelines as TopicSingle-Blind MethodTreatment OutcomeWalkingWalk Testbehaviour changeexercisemultiple sclerosissocial cognitive theorywalking mobility

Identifiers

PMID29025830
PMCPMC5654468
OpenAlexW2762119814

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.