Reliability of ventilatory parameters during cycle ergometry in multicentre trials in COPD

Area of Science:

• Pulmonary Medicine
• Exercise Physiology
• Clinical Trials

Background:

• Chronic obstructive pulmonary disease (COPD) management relies on accurate exercise performance assessment.
• Multicentre trials require validated, repeatable measurements for robust data.
• Previous studies lacked large-scale, multicentre data on exercise parameter repeatability in COPD.

Purpose of the Study:

• To determine the distribution profiles and test-retest repeatability of key exercise performance parameters.
• To assess the reliability of endurance time, inspiratory capacity, ventilation, and dyspnea ratings during constant work rate (CWR) cycle tests.
• To validate these measurements for use in multicentre clinical trials involving COPD patients.

Main Methods:

• A large multicentre study involving 463 COPD subjects (FEV1 43+/-13% predicted).
• Two run-in visits were conducted before treatment randomization, including rest, isotime, and peak exercise measurements during CWR tests at 75% maximum capacity.
• Intraclass correlation coefficients (ICC) were used to evaluate test-retest repeatability for endurance time (ET), inspiratory capacity (IC), ventilation, and Borg dyspnea scale.

Main Results:

• Endurance time (ET) demonstrated high repeatability (R = 0.84) with a skewed distribution.
• Inspiratory capacity (IC) at rest, isotime, and peak exercise showed high repeatability (R ≥ 0.87).
• Ventilation (R ≥ 0.92) and dyspnea intensity at isotime (R = 0.79) and peak exercise (R = 0.81) were also highly repeatable.

Conclusions:

• Key perceptual and ventilatory parameters are reliably measurable during CWR cycle exercise in multicentre COPD trials.
• The study validates the use of these exercise parameters for assessing moderate to very severe COPD.
• Findings support the integration of these repeatable measurements into future COPD clinical trial designs.