Chest
Original ResearchExercise TestingReproducibility of Peak Oxygen Uptake and Other Cardiopulmonary Exercise Parameters: Implications for Clinical Trials and Clinical Practice
Section snippets
Subjects
Subjects (N = 160) were screened for the PEERLESS-HF trial sponsored by Paracor Medical, Inc (Sunnyvale, CA). PEERLESS-HF is a randomized trial (35 sites) evaluating a cardiac restraint device (HeartNet; Paracor Medical, Inc), using a primary efficacy composite end point of change in peak o2, 6-min walk distance, and quality of life at 6 months. Inclusion criteria were age 18-75 years; American College of Cardiology/American Heart Association Stage C; ejection fraction ≤ 35%; and on stable
Results
Demographic and clinical characteristics of subjects screened between November 13, 2006, and June 25, 2009, are shown in Table 1. One hundred sixty subjects had two CPX tests with the same exercise mode within 14 days (mean = 4 ± 4 days). Among CPX-0, 47% (n = 75) were stopped because of symptom-limited fatigue; 35% (n = 56) for shortness of breath; and the balance for dizziness/lightheadedness (n = 5), skeletal-muscular complaints (n = 4), angina (n = 4), or other reasons (n = 16). Data from
Discussion
The use of CPX testing in clinical trials to assess intervention-related changes in cardiorespiratory parameters can be challenging and requires special equipment and staff trained to maintain the equipment and properly conduct the test.7, 8 Like all variables measured during an experiment, the parameters assessed during CPX testing are subject to both physiologic and technical variability. These concerns can be magnified when testing is conducted across dozens of sites. Using staff training
Conclusions
In conclusion, in a multisite clinical trial setting, we showed that the test-retest reproducibility of peak o2 can be quite acceptable, with a CV of 5.9%. Our data suggest that standardized laboratory and test administration guidelines and training can be employed that allow peak o2 to be used as a reliable parameter to assess exercise capacity. Finally, until more data are available to identify patients who may demonstrate greater test-retest variance and to avoid repeat testing in all
Acknowledgments
Author contributions: Dr Keteyian: contributed to the coordination and oversight of the exercise testing in which these data originated through functions of the core laboratory, the design of the analysis, data analysis and interpretation, and manuscript preparation.
Mr Brawner: contributed to the coordination and oversight of the exercise testing in which these data originated through functions of the core laboratory, the design of the analysis, data analysis and interpretation, and manuscript
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