%0 Journal Article
%A Casaburi R
%A Puente Maestu, Luis
%A Hamilton, A.
%T Validation of Constant Work Rate Cycling Endurance Time for Use in Chronic Obstructive Pulmonary Disease Clinical Trials.
%D 2024
%U https://hdl.handle.net/20.500.14352/129817
%X Rationale: A COPD Foundation working group sought toidentify measures of exercise endurance, a meaningful aspect ofphysical functioning in everyday life among patients with chronicobstructive pulmonary disease (COPD) that is not fully acceptedin regulatory decision making, hampering drug development.Objectives: To demonstrate, as we previously asserted (CasaburiCOPD 2022;9:252), that constant work rate cycling endurancetime is an appropriate exercise endurance measure in patientswith COPD.Methods: To validate this assertion, we assembled an integrateddatabase of endurance time responses, including 8 bronchodilator(2,166 subjects) and 15 exercise training (3,488 subjects) studies(Casaburi COPD 2022;9:520).Results: Construct validity was demonstrated: 1) peakphysiologic and perceptual responses were similar for constantwork rate and incremental cycling; 2) after bronchodilatortherapy, there were greater increases in endurance time inpatients with more severe airflow limitation; 3) after exercisetraining, endurance time increases were similar across airflowlimitation severities; and 4) there were correlations betweenchanges in endurance time and changes in mechanistically relatedphysiologic and perceptual variables. Test–retest reliability wasdemonstrated, with consistency of changes in endurance time attwo time points after the intervention. Responsiveness wasconfirmed, with significant increases in endurance time afteractive (but not placebo) bronchodilator therapy, with greaterincreases seen with more severe airflow limitation and afterexercise training. On the basis of regression analysis usingmultiple anchor variables, the minimum important differencefor endurance time increase is estimated to be approximately1 minute.Conclusions: Constant work rate cycling endurance time isa valid exercise endurance measure in COPD, suitable forcontributing to the evaluation of treatment benefit supportingregulatory decision making and evidence-based therapeuticrecommendation
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