Is it Time for Sports Performance Researchers to Adopt a Clinical-Type Research Framework?

For this editorial, my invited co-authors and I would like to highlight a manuscript in this issue of Int J Sports Med entitled “The effects of exercise upon symptoms and quality of life in patients diagnosed with irritable bowel syndrome: a randomised controlled trial” [5]. Not only do the authors address an interesting and important research question, but they also provide a reasonable template for anyone who might be contemplating a randomised controlled trial in the sport and exercise sciences.

The study by Daley et al. [5] is obviously more relevant to human health than to sports performance. Health researchers and clinicians have worked hard over the last 20 years to set down gold-standard research practices and methods for other researchers to adopt. For example, there is a logical and accepted “roadmap” in clinical research governing how a particular treatment or intervention should be examined for efficacy and effectiveness. Efficacy is a measure of the ability of a treatment to improve whatever condition it is indicated for, whereas effectiveness is a measure of how well a treatment works in the “real world” with the target population [6]. To cite an example that is relevant to sports performance, it is known that some substances (e.g., sodium bicarbonate) are efficacious in manipulating the acid-base balance during repeated bouts of intense exercise [4]. Nevertheless, the effectiveness of these substances for improving real athletic performance might be less clear due to the potential for inducing gastrointestinal disturbances. The exploration of issues like efficacy and effectiveness is inherent within the “phased” framework for clinical trials [12]. Alongside this framework, there are also published regulations covering how an individual randomised controlled trial should be managed and reported in a scientific journal. These regulations are laid down in the so-called “CONSORT” statement, which can be found at: http://www.consort-statement.org/.

We delimit this editorial to any study in which the primary variable is performance (or some component of athletic performance) and the research participants are competitive athletes. It is clear that there are sound studies published in the literature of this type and, in this editorial, we are able to cite some examples which have been published in past issues of Int J Sports Med. Nevertheless, we are unaware of any parallel procedures to phased clinical trials and the CONSORT statement, which have been set down by sports performance researchers to formalise the evidence-based research process. There are probably good reasons, which need to be considered, for this apparent difference between sports performance and clinical research methods. Hopefully, this editorial will help to initiate discussions at future conferences and workshops about whether such a framework is desirable for sports performance researchers and what form it might take.

References

• 1 Abel T, Knechtle B, Perret C, Esser P, von Arx P, Knecht H. Influence of chronic supplementation of arginine aspartate in endurance athletes on performance and substrate metabolism – a randomized double-blind, placebo-controlled study.  Int J Sports Med. 2005;  26 344-349
• 2 Batterham A M, Atkinson G. How big does my sample need to be? A primer on the murky world of sample size estimation.  Phys Ther Sport. 2005;  6 153-163
• 3 Burgomaster K A, Hughes S C, Heigenhauser G JF, Bradwell S N, Gibala M J. Six sessions of sprint interval training increases muscle oxidative potential and cycle endurance capacity in humans.  J Appl Physiol. 2005;  98 1985-1990
• 4 Costill Dl, Verstappen F, Kuipers H, Janssen E, Fink W. Acid-base-balance during repeated bouts of exercise – influence of HCO₃.  Int J Sports Med. 1984;  5 228-231
• 5 Daley A, Grimmett C, Roberts L, Wilson S, Fatek M, Roalfe A, Singh S. The effects of exercise upon symptoms and quality of life in patients diagnosed with irritable bowel syndrome: a randomised controlled trial.  Int J Sports Med. 2008;  29 778-782
• 6 Flay B R, Biglan A, Boruch R F, Gonzalez Castro F, Gottfredson D, Kellam S, Moscicki E K, Schinke S, Valentine J C, Ji P. Standards of evidence: criteria for efficacy, effectiveness and dissemination.  Prev Sci. 2005;  6 151-174
• 7 Groeneveld G J, Beijer C, Veldink J H, Kalmijn S, Wokke J HJ, van den Berg L H. Few adverse effects of long-term creatine supplementation in a placebo-control led trial.  Int J Sports Med. 2005;  26 307-313
• 8 Grossman P, Gibala M J, Burgomaster K A, Heigenhauser G HF. A comment on Burgomaster et al. and a general plea to consider behavioral influences in human physiology studies.  J Appl Physiol. 2005;  99 2473-2475
• 9 Kane R L, Wang J, Garrard J. Reporting in randomised clinical trials improved after adoption of the CONSORT statement.  J Clin Epidemiol. 2007;  60 241-249
• 10 Lokey E A, Tran Z V. Effects of exercise training on serum lipid and lipoprotein concentrations in women – a meta-analysis.  Int J Sports Med. 1989;  10 424-429
• 11 Moher D, Cook D J, Eastwood S. Improving the quality of reports of meta-analyses of randomised controlled trials.  Lancet. 1999;  354 1896-1900
• 12 Thall P F. A review of phase 2 – 3 clinical trials.  Lifetime Data Anal. 2008;  14 37-53
• 13 van Staveren W A, Burema J, de Groot C PGM. The SENECA study: potentials and problems in assessing dietary changes over time.  Int J Sports Med. 1997;  18 S195-199
• 14 Varlet-Marie E, Gaudard A, Audran M, Gomeni R, Bressolle F. Pharmacokinetic-pharmacodynamic modelling of recombinant human erythropoietin in athletes.  In J Sports Med. 2003;  24 252-257
• 15 Wright-Carpenter T, Opolon P, Appell H J, Meijer H, Wehling P, Lir L M. Treatment of muscle injuries by local administration of autologous conditioned serum. Animal experiments using a muscle contusion model.  In J Sports Med. 2004;  25 582-587