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Original Research: EXERCISE TESTING |

Reproducibility of Peak Oxygen Uptake and Other Cardiopulmonary Exercise Parameters: Implications for Clinical Trials and Clinical Practice

Steven J. Keteyian, PhD; Clinton A. Brawner, MS; Jonathan K. Ehrman, PhD; Russell Ivanhoe, MD; John P. Boehmer, MD; William T. Abraham, MD; for the PEERLESS-HF Trial Investigators
Author and Funding Information

From the Division of Cardiovascular Medicine (Drs Keteyian and Ehrman and Mr Brawner), Henry Ford Hospital, Detroit, MI; Paracor Medical, Inc (Dr Ivanhoe), Sunnyvale, CA; Heart and Vascular Institute (Dr Boehmer), The Penn State College of Medicine, Hershey, PA; and the Division of Cardiovascular Medicine (Dr Abraham), The Ohio State University Medical Center, Columbus, OH.

Correspondence to: Steven J. Keteyian, PhD, Preventive Cardiology, Henry Ford Hospital, 6525 Second Ave, Detroit, MI 48202; e-mail: sketeyi1@hfhs.org


Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).


© 2010 American College of Chest Physicians


Chest. 2010;138(4):950-955. doi:10.1378/chest.09-2624
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Background:  Clinical trialists involved in projects aimed at assessing the impact of a device or therapy on exercise capacity must select an end point that can detect a therapy-derived change and do so in a manner that is both sensitive to the change and valid. Using baseline data from the Prospective Evaluation of Elastic Restraint to Lessen the Effects of Heart Failure (PEERLESS-HF) trial, we describe the coefficient of variation (CV) for peak oxygen uptake (V˙ o2) and other parameters measured during a cardiopulmonary exercise (CPX) test.

Methods:  Prior to conducting CPX testing, a CPX core laboratory conducted training with testing staff at each site, and a standardized quality assurance protocol was completed. During screening, subjects performed two symptom-limited CPX tests (CPX-0 and CPX-1) within 14 days.

Results:  The CVs for peak V˙ o2, ventilatory efficiency, and ventilatory-derived anaerobic threshold were 5.9%, 4.8%, and 6.8%, respectively. During CPX-0, the percentage of subjects with a respiratory exchange ratio (RER) < 1.05 who increased their peak V˙ o2 by ≥ 6% during CPX-1 was 47%, compared with 12% of subjects also with an RER < 1.05 who experienced a decrease in peak V˙ o2 ≥ 6%.

Conclusions:  In a multisite clinical trial setting, we showed that the achieved test-retest reproducibility for peak V˙ o2 can be acceptable, as evidenced by a CV at 5.9%. Until more data are available to identify patients who may demonstrate greater test-retest variance and to avoid repeat testing in all subjects at baseline, clinical trialists might consider repeating tests when RER < 1.05.

Trial registration:  clinicaltrials.gov; Identifier: NCT00382863


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