Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Aug 11;11(8):e048218.
doi: 10.1136/bmjopen-2020-048218.

Comparing the reporting and conduct quality of exercise and pharmacological randomised controlled trials: a systematic review

Scott C Adams  1   2   3 , Julia McMillan  4 , Kirsten Salline  5 , Jessica Lavery  6 , Chaya S Moskowitz  6 , Konstantina Matsoukas  7 , Maggie M Z Chen  3 , Daniel Santa Mina  3   8 , Jessica M Scott #  9   10 , Lee W Jones #  11   10
Affiliations

Comparing the reporting and conduct quality of exercise and pharmacological randomised controlled trials: a systematic review

Scott C Adams et al. BMJ Open. .

Abstract

Objective: Evaluate the quality of exercise randomised controlled trial (RCT) reporting and conduct in clinical populations (ie, adults with or at risk of chronic conditions) and compare with matched pharmacological RCTs.

Design: Systematic review.

Data sources: Embase (Elsevier), PubMed (NLM) and CINAHL (EBSCO).

Study selection: RCTs of exercise in clinical populations with matching pharmacological RCTs published in leading clinical, medical and specialist journals with impact factors ≥15.

Review methods: Overall RCT quality was evaluated by two independent reviewers using three research reporting guidelines (ie, Consolidated Standards of Reporting Trials (CONSORT; pharmacological RCTs)/CONSORT for non-pharmacological treatments; exercise RCTs), CONSORT-Harms, Template for Intervention Description and Replication) and two risk of bias assessment (research conduct) tools (ie, Cochrane Risk of Bias, Jadad Scale). We compared research reporting and conduct quality within exercise RCTs with matched pharmacological RCTs, and examined factors associated with quality in exercise and pharmacological RCTs, separately.

Findings: Forty-eight exercise RCTs (11 658 patients; median sample n=138) and 48 matched pharmacological RCTs were evaluated (18 501 patients; median sample n=160). RCTs were conducted primarily in cardiovascular medicine (43%) or oncology (31%). Overall quality score (composite of all research reporting and conduct quality scores; primary endpoint) for exercise RCTs was 58% (median score 46 of 80; IQR: 39-51) compared with 77% (53 of 68; IQR: 47-58) in the matched pharmacological RCTs (p≤0.001). Individual quality scores for trial reporting and conduct were lower in exercise RCTs compared with matched pharmacological RCTs (p≤0.03). Factors associated with higher overall quality scores for exercise RCTs were journal impact factor (≥25), sample size (≥152) and publication year (≥2013).

Conclusions and relevance: Research reporting and conduct quality within exercise RCTs is inferior to matched pharmacological RCTs. Suboptimal RCT reporting and conduct impact the fidelity, interpretation, and reproducibility of exercise trials and, ultimately, implementation of exercise in clinical populations.

Prospero registration number: CRD42018095033.

Keywords: clinical pharmacology; clinical trials; rehabilitation medicine; statistics & research methods.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram. RCT, randomised controlled trial.
See this image and copyright information in PMC

References

    1. Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports 2015;25 Suppl 3:1–72. 10.1111/sms.12581 - DOI - PubMed
    1. Mezzani A, Hamm LF, Jones AM, et al. . Aerobic exercise intensity assessment and prescription in cardiac rehabilitation: a joint position statement of the European association for cardiovascular prevention and rehabilitation, the American association of cardiovascular and pulmonary rehabilitation and the Canadian association of cardiac rehabilitation. Eur J Prev Cardiol 2013;20:442–67. 10.1177/2047487312460484 - DOI - PubMed
    1. Rochester CL, Vogiatzis I, Holland AE, et al. . An official American thoracic Society/European respiratory Society policy statement: enhancing implementation, use, and delivery of pulmonary rehabilitation. Am J Respir Crit Care Med 2015;192:1373–86. 10.1164/rccm.201510-1966ST - DOI - PubMed
    1. Sanft T, Denlinger CS, Armenian S. NCCN guidelines insights: survivorship, version 2.2019: Featured updates to the NCCN guidelines. J Natl Compr Canc Netw 2019;17:784–94. - PMC - PubMed
    1. Guyatt GH, Oxman AD, Vist GE, et al. . Grade: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924–6. 10.1136/bmj.39489.470347.AD - DOI - PMC - PubMed

Publication types