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First, do no harm: a call to action to improve the evaluation of harms in clinical exercise research
  1. Simon Nørskov Thomsen1,
  2. Alejandro Lucia2,
  3. Rosalind R Spence3,4,
  4. Fabiana Braga Benatti5,
  5. Michael J Joyner6,
  6. Ronan Martin Griffin Berg1,7,
  7. Mathias Ried-Larsen1,8,
  8. Casper Simonsen1
  1. 1 Centre for Physical Activity Research, Rigshospitalet, Copenhagen, Region Hovedstaden, Denmark
  2. 2 Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain
  3. 3 Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia
  4. 4 Improving Health Outcomes for People (ihop) Research Group, Brisbane, Queensland, Australia
  5. 5 Faculdade de Ciências Aplicadas, Universidade Estadual de Campinas, Limeira, SP, Brazil
  6. 6 Department of Anesthesiology & Perioperative Medicine, Mayo Clinic, Rochester, New York, USA
  7. 7 Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Region Hovedstaden, Denmark
  8. 8 Institute of Sports and Clinical Biomechanics, University of Southern Denmark, Odense, Syddanmark, Denmark
  1. Correspondence to Dr Casper Simonsen, Centre for Physical Activity Research, Rigshospitalet, Copenhagen, Denmark; casper.simonsen{at}

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Exercise as medicine has emerged as an independent discipline in clinical research. Over the last decades, numerous randomised controlled trials (RCTs) have documented the beneficial effects of exercise on various patient-related, disease-related and health-related outcomes in clinical populations.1 Nevertheless, the evaluation of harms in clinical exercise research remains unsatisfactory (table 1).2 3 For instance, nearly half of all exercise trials do not report harms, and there is evidence of selective non-reporting of harms.2 4 5 Furthermore, emerging evidence indicates that exercise might increase the risk of serious adverse events in certain populations.2 We contend that this is concerning; as for any clinical intervention, the benefits of exercise should be carefully balanced against accurate risk estimates of harms to appropriately inform evidence-based clinical use. With this call to action, we aim to improve the evaluation of harms in clinical exercise research.

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Table 1

Suboptimal practices of harms collection, analysis and interpretation as well as their consequences2 3 5

Update of exercise trial reporting guidelines

The Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network reporting guidelines have been instrumental in improving research reporting. However, we assert that the exercise-specific reporting guidelines do not adequately encompass several critical aspects relevant to clinical exercise prescription.6 For example, in the Consensus on Exercise Reporting Template,6 the reporting of harms focuses solely on adverse …

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  • X @RiedMathias

  • Contributors SNT, MR-L, RMGB and CS conceived the paper. SNT and CS wrote the first draft. All authors critically revised the manuscript and approved the final version. All authors quality for authorship and all persons qualifying for authorship are listed as authors.

  • Funding The authors have not received specific funding for the present research. The Centre for Physical Activity Research (CFAS) is supported by TrygFonden (grants ID: 101390, 20045 and 125132).

  • Competing interests None declared.

  • Provenance and peer review Commissioned; externally peer reviewed.