Evidence map›Paper›PMID 27927226›Full record

Trial reportTrials2016

What is the impact of obtaining medical clearance to participate in a randomised controlled trial examining a physical activity intervention on the socio-demographic and risk factor profiles of included participants?

Mitch J Duncan, Richard R Rosenkranz, Corneel Vandelanotte, Cristina M Caperchione, Amanda L Rebar, Anthony J Maeder, Rhys Tague, Trevor N Savage, Anetta van Itallie, W Kerry Mummery and 1 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.6field-weighted citation impact, top 27% 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

7 citing papers in PubMed, 16 citations in OpenAlex.

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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

11 authors at 7 institutions in 3 countries.

Mitch J DuncanSchool of Medicine and Public Health, Priority Research Centre for Physical Activity and Nutrition, Faculty of Health and Medicine, University of Newcastle, Newcastle, NSW, Australia. mitch.duncan@newcastle.edu.au.
Richard R RosenkranzDepartment of Food, Nutrition, Dietetics and Health, Kansas State University, Manhattan, KS, USA.
Corneel VandelanotteSchool of Human Health and Social Sciences, Central Queensland University, Rockhampton, QLD, Australia.
Cristina M CaperchioneSchool of Health and Exercise Science, University of British Columbia, Kelowna, BC, Canada.
Amanda L RebarSchool of Human Health and Social Sciences, Central Queensland University, Rockhampton, QLD, Australia.
Anthony J MaederSchool of Health Science, Flinders University, Adelaide, SA, Australia.
Rhys TagueSchool of Computing, Engineering and Mathematics, Western Sydney University, Sydney, NSW, Australia.
Trevor N SavageSchool of Science and Health, Western Sydney University, Sydney, NSW, Australia.
Anetta van ItallieSchool of Human Health and Social Sciences, Central Queensland University, Rockhampton, QLD, Australia.
W Kerry MummeryFaculty of Physical Education and Recreation, University of Alberta, Edmonton, AB, Canada.
Gregory S KoltSchool of Science and Health, Western Sydney University, Sydney, NSW, Australia.
Central Queensland University · AUWestern Sydney University · AUFlinders University · AUKansas State University · USUniversity of Alberta · CAUniversity of British Columbia · CAUniversity of Newcastle Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRequiring individuals to obtain medical clearance to exercise prior to participation in physical activity interventions is common. The impact this has on the socio-demographic characteristic profiles of participants who end up participating in the intervention is not clear.

methodsAs part of the multi-component eligibility screening for inclusion in a three-arm randomised controlled trial examining the efficacy of a web-based physical activity intervention, individuals interested in participating were required to complete the Physical Activity Readiness Questionnaire (PAR-Q). The PAR-Q identified individuals as having lower or higher risk. Higher-risk individuals were required to obtain medical exercise clearance prior to enrolment. Comparisons of the socio-demographic characteristics of the lower- and higher-risk individuals were performed using t tests and chi-square tests (p = 0.05).

resultsA total of 1244 individuals expressed interest in participating, and 432 were enrolled without needing to undergo further screening. Of the 251 individuals required to obtain medical clearance, 148 received clearance, 15 did not receive clearance and 88 did not return any form of clearance. A total of 105 individuals were enrolled after obtaining clearance, and the most frequent reason for being required to seek clearance was for using blood pressure/heart condition medication. Higher-risk individuals were significantly older, had a higher body mass index and engaged in more sedentary behaviour than lower-risk individuals.

conclusionsUse of more inclusive participant screening protocols that maintain high levels of participant safety are encouraged. Allowing individuals to obtain medical clearance to participate can result in including a more diverse population likely to benefit most from participation.

trial registrationAustralian New Zealand Clinical Trials Registry ( ACTRN12611000157976 ). Registered on 9 February 2011.

Indexed as

Health StatusPatient SelectionPhysical FitnessResearch SubjectsAdultAgedAge FactorsCardiovascular AgentsChi-Square DistributionExercise TherapyExercise ToleranceFemaleHumansMaleMiddle AgedNew South WalesCardiovascular AgentsMedical clearanceParticipant characteristicsPhysical activityRandomised controlled trialRecruitment

Identifiers

PMID27927226
PMCPMC5142331
OpenAlexW2560007922

What OpenQuestion holds

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LicenceCC BY
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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.