scholarly journals A Conceptual Framework for Use of Increased Endurance Time During Constant Work Rate Cycle Ergometry as a Patient-Focused Meaningful Outcome in COPD Clinical Trials

2022 ◽  
Vol 9 (1) ◽  
Author(s):  
Richard Casaburi ◽  
Debora D. Merrill ◽  
Gale Harding ◽  
Nancy K. Leidy ◽  
Harry B. Rossiter ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Conceptual Framework ◽  
Cycle Ergometry ◽  
Work Rate ◽  
Endurance Time ◽  
Constant Work Rate

scholarly journals Comparative measurement properties of constant work rate cycling and the endurance shuttle walking test in COPD: the TORRACTO® clinical trial

2020 ◽  
Vol 14 ◽  
pp. 175346662092685
Author(s):  
François Maltais ◽  
Denis E. O’Donnell ◽  
Alan Hamilton ◽  
Yihua Zhao ◽  
Richard Casaburi
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Intraclass Correlation ◽  
Work Rate ◽  
Measurement Properties ◽  
Chronic Obstructive ◽  
Comparative Measurement ◽  
Endurance Time ◽  
Walking Test ◽  
Constant Work Rate

Background: Exercise tolerance is an important endpoint in chronic obstructive pulmonary disease (COPD) clinical trials. Little is known about the comparative measurement properties of constant work rate cycle ergometry (CWRCE) and the endurance shuttle walking test (ESWT). The objective of this sub-analysis of the TORRACTO® study was to directly compare the endurance measurement properties of CWRCE and ESWT in patients with COPD in a multicentre, multinational setting. We predicted that both tests would be similarly reliable, but that the ESWT would be more responsive to bronchodilation than CWRCE. Methods: This analysis included 151 patients who performed CWRCE and ESWT at baseline and week 6 after receiving once-daily placebo, tiotropium/olodaterol (T/O) 2.5/5 μg or T/O 5/5 μg. Reproducibility was assessed by comparing their respective performance at baseline and week 6 in the placebo group. Responsiveness to bronchodilation was assessed by comparing endurance time at week 6 with T/O with baseline values and placebo. The locus of symptom limitation and end-exercise Borg scales for breathing and leg discomfort for both tests were also analysed. Results: The intraclass correlation coefficients for CWRCE and ESWT were 0.56 [95% confidence interval (CI) 0.37–0.71] and 0.75 (95% CI 0.63–0.84). More patients were limited by breathing discomfort during the ESWT than during CWRCE, whereas more patients were limited by leg discomfort or breathing/leg discomfort during CWRCE than the ESWT ( p <0.0001). Both tests were responsive to bronchodilator treatment: there was a 19% increase in endurance time from baseline at week 6 ( p = 0.0006) assessed with CWRCE, and a 20% increase in endurance time assessed with ESWT ( p = 0.0013). Conclusions: Both exercise tests performed well in a multicentre clinical trial. Although the locus of symptom limitation differed between the two tests, both were reliable and responsive to bronchodilation. For future clinical trials, the choice of test should depend on the study requirements. ClinicalTrials.gov identifier: NCT01525615. The reviews of this paper are available via the supplemental material section.

scholarly journals Effect of 12 weeks of once-daily tiotropium/olodaterol on exercise endurance during constant work-rate cycling and endurance shuttle walking in chronic obstructive pulmonary disease

2018 ◽  
Vol 12 ◽  
pp. 175346581875509 ◽  
Author(s):  
François Maltais ◽  
Denis O’Donnell ◽  
Juan Bautista Gáldiz Iturri ◽  
Anne-Marie Kirsten ◽  
Dave Singh ◽  
...  
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Pulmonary Disease ◽  
Cycle Ergometry ◽  
Work Rate ◽  
Chronic Obstructive ◽  
Double Blind ◽  
Endurance Time ◽  
Obstructive Pulmonary Disease ◽  
Once Daily ◽  
Constant Work Rate

Background: The TORRACTO® study evaluated the effects of tiotropium/olodaterol versus placebo on endurance time during constant work-rate cycling and constant speed shuttle walking in patients with chronic obstructive pulmonary disease (COPD) after 12 weeks of treatment. Methods: The effects of once-daily tiotropium/olodaterol (2.5/5 and 5/5 μg) on endurance time during constant work-rate cycle ergometry (CWRCE) after 6 and 12 weeks of treatment were compared with placebo in patients with COPD in a randomized, double-blind, placebo-controlled, parallel-group clinical trial. Endurance time during the endurance shuttle walk test (ESWT) after 6 and 12 weeks of treatment was also evaluated in a subset of patients. Results: A total of 404 patients received treatment, with 165 participating in the ESWT substudy. A statistically significant improvement in endurance time during CWRCE was observed after 12 weeks (primary endpoint) with tiotropium/olodaterol 5/5 µg [14% ( p = 0.02)] but not with tiotropium/olodaterol 2.5/5 µg [9% ( p = 0.14)] versus placebo. In the ESWT substudy, a trend to improvement in endurance time during ESWT after 12 weeks (key secondary endpoint) was observed with tiotropium/olodaterol 5/5 µg [21% ( p = 0.055)] and tiotropium/olodaterol 2.5/5 µg [21% ( p = 0.056)] versus placebo. Conclusion: Tiotropium/olodaterol 5/5 µg improved endurance time during cycle ergometry versus placebo, with a strong tendency to also improve walking endurance time. [ ClinicalTrials.gov identifier: NCT01525615.]

Predictors of low endurance time in constant work rate cycle testing in COPD

2019 ◽  
Author(s):  
Richard Casaburi ◽  
Alan Hamilton ◽  
Martijn Spruit ◽  
Debora Merrill ◽  
Gale Harding ◽  
...  
Keyword(s):  
Work Rate ◽  
Endurance Time ◽  
Constant Work Rate

scholarly journals Perceived Locus of Symptom Limitation during Constant Work Rate Cycle Ergometry in COPD Patients Treated with Tiotropium

CHEST Journal ◽  
2004 ◽  
Vol 126 (4) ◽  
pp. 838S ◽  
Author(s):  
Denis E. O’Donnell ◽  
Francois Maltais ◽  
Peter Frith ◽  
Anne Marie Southcott ◽  
Steven Kesten ◽  
...  
Keyword(s):  
Cycle Ergometry ◽  
Work Rate ◽  
Copd Patients ◽  
Constant Work Rate

scholarly journals Does nebulized fentanyl relieve dyspnea during exercise in healthy man?

2015 ◽  
Vol 118 (11) ◽  
pp. 1406-1414 ◽  
Author(s):  
Houssam G. Kotrach ◽  
Jean Bourbeau ◽  
Dennis Jensen
Keyword(s):  
Chest Wall ◽  
Opioid Receptor ◽  
Work Rate ◽  
Receptor Subtype ◽  
Negative Consequences ◽  
Double Blind ◽  
Exertional Dyspnea ◽  
Endurance Time ◽  
Constant Work Rate ◽  
Exercise Endurance

Few therapies exist for the relief of dyspnea in restrictive lung disorders. Accumulating evidence suggests that nebulized opioids selective for the mu-receptor subtype may relieve dyspnea by modulating intrapulmonary opioid receptor activity. Our respective primary and secondary objectives were to test the hypothesis that nebulized fentanyl (a mu-opioid receptor agonist) relieves dyspnea during exercise in the presence of abnormal restrictive ventilatory constraints and to identify the physiological mechanisms of this improvement. In a randomized, double-blind, placebo-controlled crossover study, we examined the effect of 250 μg nebulized fentanyl, chest wall strapping (CWS), and their interaction on detailed physiological and perceptual responses to constant work rate cycle exercise (85% of maximum incremental work rate) in 14 healthy, fit young men. By design, CWS decreased vital capacity by ∼20% and mimicked the negative consequences of a mild restrictive lung disorder on exercise endurance time and on dyspnea, breathing pattern, dynamic operating lung volumes, and diaphragmatic electromyographic and respiratory muscle function during exercise. Compared with placebo under both unrestricted control and CWS conditions, nebulized fentanyl had no effect on exercise endurance time, integrated physiological response to exercise, sensory intensity, unpleasantness ratings of exertional dyspnea. Our results do not support a role for intrapulmonary opioids in the neuromodulation of exertional dyspnea in health nor do they provide a physiological rationale for the use of nebulized fentanyl in the management of dyspnea due to mild restrictive lung disorders, specifically those arising from abnormalities of the chest wall and not affiliated with airway inflammation.

scholarly journals Locus of Symptom Limitation and Exercise Response to Bronchodilation in Chronic Obstructive Pulmonary Disease

2007 ◽  
Vol 30 (3) ◽  
pp. 37
Author(s):  
Dominic Deschênes ◽  
Véronique Pepin ◽  
Didier Saey ◽  
Pierre LeBlanc ◽  
François Maltais
Keyword(s):  
Ipratropium Bromide ◽  
Work Rate ◽  
Chronic Obstructive ◽  
Endurance Time ◽  
Obstructive Pulmonary Disease ◽  
Twitch Force ◽  
Exercise Limitation ◽  
Exercise Response ◽  
Constant Work Rate ◽  
Walking Tests

Background: We previously reported that the occurrence of contractile fatigue of the quadriceps during exercise in patients with COPD reduced the likelihood of acute bronchodilation to improve the endurance time to constant work rate exercise. The purpose of the present study was to assess whether the perception of dyspnea and leg fatigue during exercise could be used to predict the exercise response to acute bronchodilation in this population. Methods: Sixty-eight patients with COPD performed either two constant work-rate cycling exercises or two endurance shuttle walking tests. These tests were preceded by nebulization of placebo or 500 mg ipratropium bromide. Changes in FEV1 and in the endurance time with bronchodilation were measured. The changes in quadriceps twitch force after exercise were evaluated. In addition, we assessed dyspnea and perception of leg fatigue on Borg scale as well as the locus of exercise limitation (dyspnea, leg fatigue, or both). Results: The locus of symptom limitation was useful to predict the exercise response to bronchodilation; patients stopping exercise because of leg fatigue or due to a combination of dyspnea/leg fatigue showed a smaller improvement in endurance time to constant work rate exercise with bronchodilation compared with those stopping because of dyspnea. Subjective and objective evidences of fatigue were related: patients who stopped exercising because of leg fatigue showed a larger fall in quadriceps twitch force compared to patients who stopped for dyspnea. Conclusion: The assessment of the locus of symptom limitation during constant work rate exercise is useful to predict the improvement in endurance time following acute bronchodilation in patients with COPD.

scholarly journals Effects of combined tiotropium/olodaterol on inspiratory capacity and exercise endurance in COPD

2017 ◽  
Vol 49 (4) ◽  
pp. 1601348 ◽  
Author(s):  
Denis E. O'Donnell ◽  
Richard Casaburi ◽  
Peter Frith ◽  
Anne Kirsten ◽  
Dorothy De Sousa ◽  
...  
Keyword(s):  
Work Rate ◽  
Chronic Obstructive ◽  
Inspiratory Capacity ◽  
Post Dose ◽  
Double Blind ◽  
Endurance Time ◽  
Obstructive Pulmonary Disease ◽  
Once Daily ◽  
Constant Work Rate ◽  
Exercise Endurance

Two replicate, double-blind, 6-week, incomplete-crossover studies (MORACTO 1 and 2) assessed the effects of tiotropium/olodaterol on inspiratory capacity and exercise endurance time in patients with moderate to severe chronic obstructive pulmonary disease.For each patient, four of five treatments were administered once daily for 6 weeks, with a 21-day washout between treatments: tiotropium/olodaterol 2.5/5 µg or 5/5 µg, tiotropium 5 µg, olodaterol 5 µg or placebo, all via the Respimat inhaler. Primary outcomes were inspiratory capacity prior to exercise and exercise endurance time during constant work-rate cycle ergometry to symptom limitation at 75% of peak incremental work rate after 6 weeks (2 h post-dose).295 and 291 patients were treated in MORACTO 1 and 2, respectively. Tiotropium/olodaterol 2.5/5 and 5/5 µg provided significant improvements in inspiratory capacity versus placebo and monotherapies (p<0.0001), and significant improvements in exercise endurance time versus placebo (p<0.0001). Intensity of breathing discomfort was reduced following both doses of tiotropium/olodaterol versus placebo (p<0.0001).Once-daily tiotropium/olodaterol yielded improvements in lung hyperinflation versus placebo and statistically significant improvements versus monotherapies. Tiotropium/olodaterol also showed improvements in dyspnoea and exercise tolerance versus placebo but not consistently versus monotherapies.

Comparative Measurement Properties of Constant Work-Rate Cycling and Endurance Shuttle Walking in Patients with COPD: Data from the TORRACTO Study

Pneumologie ◽  
2018 ◽  
Vol 72 (S 01) ◽  
pp. S90-S90
Author(s):  
K Siemon ◽  
F Maltais ◽  
DE O'Donnell ◽  
A Hamilton ◽  
Y Zhao ◽  
...  
Keyword(s):  
Work Rate ◽  
Measurement Properties ◽  
Comparative Measurement ◽  
Constant Work Rate

Endurance cycle ergometry tests performed at a sub‐maximal work rate elicit peak physiological and symptom responses in adults with cystic fibrosis

2021 ◽  
Vol 51 (7) ◽  
pp. 1168-1172
Author(s):  
Abbey Sawyer ◽  
Vinicius Cavalheri ◽  
Sue Jenkins ◽  
Jamie Wood ◽  
Bhajan Singh ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Cycle Ergometry ◽  
Work Rate

scholarly journals Conceptual Framework to Support Clinical Trial Optimization and End-to-End Enrollment Workflow

2019 ◽  
pp. 1-10 ◽  
Author(s):  
Neha M. Jain ◽  
Alison Culley ◽  
Teresa Knoop ◽  
Christine Micheel ◽  
Travis Osterman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Knowledge Representation ◽  
Conceptual Framework ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Prospective Clinical Trial ◽  
Future Trends ◽  
Current State ◽  
Evaluation Strategies

In this work, we present a conceptual framework to support clinical trial optimization and enrollment workflows and review the current state, limitations, and future trends in this space. This framework includes knowledge representation of clinical trials, clinical trial optimization, clinical trial design, enrollment workflows for prospective clinical trial matching, waitlist management, and, finally, evaluation strategies for assessing improvement.

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