Biological quality control for cardiopulmonary exercise testing in multicenter clinical trials

Pórszász, János; Blonshine, Susan; Cao, Robert; Paden, Heather; Casaburi, Richard; Rossiter, Harry B.

doi:10.1186/s12890-016-0174-8

Cited by 12 publications

(7 citation statements)

References 34 publications

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“…For CMR, a sample of 75 individuals per group was estimated to identify a 3% difference between groups in ejection fraction and assuming an SD of 4.5 and a standardized difference of 0.43. For exercise stress testing, a sample of 55 individuals per group was estimated to detect a 15% difference in indexed V̇ o 2 …”

Section: Methodsmentioning

confidence: 99%

Exercise Capacity in Young Adults Born Small for Gestational Age

et al. 2021

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Being born small for gestational age (SGA), approximately 10% of all births, is associated with increased risk of cardiovascular mortality in adulthood, but mechanistic pathways are unclear. Cardiac remodeling and dysfunction occur in fetuses SGA and children born SGA, but it is uncertain whether and how these changes persist into adulthood.OBJECTIVE To evaluate baseline cardiac function and structure and exercise capacity in young adults born SGA. DESIGN, SETTING, AND PARTICIPANTSThis cohort study conducted from January 2015 to January 2018 assessed a perinatal cohort born at a tertiary university hospital in Spain between 1975 and 1995. Participants included 158 randomly selected young adults aged 20 to 40 years born SGA (birth weight below the 10th centile) or with intrauterine growth within standard reference ranges (controls). Participants provided their medical history, filled out questionnaires regarding smoking and physical activity habits, and underwent incremental cardiopulmonary exercise stress testing, cardiac magnetic resonance imaging, and a physical examination, with blood pressure, glucose level, and lipid profile data collected. EXPOSURE Being born SGA. MAIN OUTCOMES AND MEASURES Cardiac structure and function assessed by cardiac magnetic resonance imaging, including biventricular end-diastolic shape analysis. Exercise capacity assessed by incremental exercise stress testing. RESULTS This cohort study included 81 adults born SGA (median age at study, 34.4 years [IQR, 30.8-36.7 years]; 43 women [53%]) and 77 control participants (median age at study, 33.7 years [interquartile range (IQR), 31.0-37.1 years]; 33 women [43%]). All participants were of White race/ethnicity and underwent imaging, whereas 127 participants (80% of the cohort; 66 control participants and 61 adults born SGA) completed the exercise test. Cardiac shape analysis showed minor changes at rest in right ventricular geometry (DeLong test z, 2.2098; P = .02) with preserved cardiac function in individuals born SGA. However, compared with controls, adults born SGA had lower exercise capacity, with decreased maximal workload (mean [SD], 180 [62] W vs 214 [60] W; P = .006) and oxygen consumption (median, 26.0 mL/min/kg [IQR, 21.5-33.5 mL/min/kg vs 29.5 mL/min/kg [IQR, 24.0-36.0 mL/min/kg]; P = .02). Exercise capacity was significantly correlated with left ventricular mass (ρ = 0.7934; P < .001).CONCLUSIONS AND RELEVANCE This cohort of young adults born SGA had markedly reduced exercise capacity. These results support further research to clarify the causes of impaired exercise capacity and the potential association with increased cardiovascular mortality among adults born SGA.

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Section: Methodsmentioning

confidence: 99%

Exercise Capacity in Young Adults Born Small for Gestational Age

et al. 2021

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“…Computerized MC can determine CRF with CVs between 4% to 9% due to several sources of variation, such as environmental conditions, biological variability, and technical characteristics of the metabolic cart [9]. Human physiological variation might account for between 5% to 10% of differences during cycling at moderate intensity under steady-state conditions [28,29]. In addition, given the fluctuation of breath-by-breath data, its processing may also contribute to variation in ventilatory parameters outcomes at submaximal intensities.…”

Section: Discussionmentioning

confidence: 99%

Cardiopulmonary Exercise Testing in the Context of an Aerosol-Borne Infectious Disease: Comparison between the Jaeger Oxycon Pro and the COSMED Quark RMR Metabolic Carts

Muñoz-Muñoz,

Leal-Martín,

Baltasar-Fernandez

et al. 2023

Preprint

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Several factors, such as internal algorithm, sensor technology, and obsolescence might skew outcomes when comparing different gas analysers measurements during CPET. Besides aerosol borne infectious disease are a source of contamination during cardiopulmonary exercise tests (CPET). Thus, the main aim of this study was to determine the agreement degree between the Quark RMR and the Jaeger Oxycon Pro, using an antibacterial filter with the latter. Forty-two participants (19-54 years old) performed two non-consecutive maximal graded exercise tests on a cycle-ergometer on two counterbalance and different days using the Oxycon Pro and the Quark RMR in a randomized order. Differences between devices were tested using a generalized linear model adjusted by Bonferroni, and correlation and agreement was assessed using Pearson’s correlation coefficient (R), intraclass coefficient correlation (ICC), Lin’s concordance correlation coefficient (CCC) and Bland-Altman plots. No significant differences were found between devices in any of metabolic or ventilatory parameters for cardiorespiratory fitness assessment (VO2max: 3131.3±882.1 vs. 3189.8±894.8, p=0.071, VCO2max: 3436.3±936.0 vs. 3550.3±1043.2, p=0.071, for Quark RMR and Oxycon Pro, respectively). However, Bland-Altman plots showed a trivial tendency towards Oxycon Pro overestimation relative to Quark RMR as air flow volume increases. Both devices showed strong correlation and high level of agreement during maximal and submaximal exercise intensities (Pearson’s R: 0.974 & 0.977; ICC: 0.985 & 0.987; Lin’s CCC: 0.971 & 0.974, for VO2 and VCO2, respectively). Therefore, providing consistency to CPET data comparison between both devices, and insight into whether the use of these metabolic carts could be interchangeable or combined when a single device cannot be used for CPET assessment.

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“…Even when automated system calibration appears accurate, results may be erroneous ( 61 ). Biological validation can be achieved by testing laboratory staff on a monthly basis at matched submaximal work rates, and for VO 2 /work rate slope ( 62 ).…”

Section: Methodsmentioning

confidence: 99%

Cardiopulmonary Exercise Test Methodology for Assessing Exertion Intolerance in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Stevens¹,

Snell²,

Stevens³

et al. 2018

Front. Pediatr.

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Background: Concise methodological directions for administration of serial cardiopulmonary exercise testing (CPET) are needed for testing of patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Maximal CPET is used to evaluate the coordinated metabolic, muscular, respiratory and cardiac contributions to energy production in patients with ME/CFS. In this patient population, CPET also elicits a robust post-exertional symptom flare (termed, post-exertional malaise); a cardinal symptom of the disease. CPET measures are highly reliable and reproducible in both healthy and diseased populations. However, evidence to date indicates that ME/CFS patients are uniquely unable to reproduce CPET measures during a second test, despite giving maximal effort during both tests, due to the effects of PEM on energy production.Methodology: To document and assess functional impairment due to the effects of post-exertional malaise in ME/CFS, a 2-day CPET procedure (2-day CPET) has been used to first measure baseline functional capacity (CPET1) and provoke post-exertional malaise, then assess changes in CPET variables 24 h later with a second CPET to assess the effects of post-exertional malaise on functional capacity. The second CPET measures changes in energy production and physiological function, objectively documenting the effects of post-exertional malaise. Use of CPET as a standardized stressor to induce post-exertional malaise and quantify impairment associated with post-exertional malaise has been employed to examine ME/CFS pathology in several studies. This article discusses the results of those studies, as well as the standardized techniques and procedures for use of the 2-day CPET in ME/CFS patients, and potentially other fatiguing illnesses.Conclusions: Basic concepts of CPET are summarized, and special considerations for performing CPET on ME/CFS patients are detailed to ensure a valid outcome. The 2-day CPET methodology is outlined, and the utility of the procedure is discussed for assessment of functional capacity and exertion intolerance in ME/CFS.

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Biological quality control for cardiopulmonary exercise testing in multicenter clinical trials

Cited by 12 publications

References 34 publications

Exercise Capacity in Young Adults Born Small for Gestational Age

Exercise Capacity in Young Adults Born Small for Gestational Age

Cardiopulmonary Exercise Testing in the Context of an Aerosol-Borne Infectious Disease: Comparison between the Jaeger Oxycon Pro and the COSMED Quark RMR Metabolic Carts

Cardiopulmonary Exercise Test Methodology for Assessing Exertion Intolerance in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

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