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Trial · NCT07541378

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryEndurance time during constant-work-rate cycle ergometry (CWRCE)Baseline and after 28 days of each treatment periodChange in endurance time (ET) during constant-work-rate exercise testing at 80% peak workload, measured by cardiopulmonary exercise testing (CPET).
SecondaryPeak oxygen uptake (VO₂peak) during CPETBaseline and after 28 days of each treatment periodChange in peak oxygen uptake measured during cardiopulmonary exercise testing (CPET).
SecondaryOxygen uptake (VO₂) at isotime during CPETBaseline and after 28 days of each treatment periodChange in oxygen uptake at isotime measured during cardiopulmonary exercise testing (CPET).
SecondaryForced expiratory volume in 1 second (FEV₁)Baseline and after 28 days of each treatment periodChange in forced expiratory volume in 1 second (FEV₁).
SecondaryForced vital capacity (FVC)Baseline and after 28 days of each treatment periodChange in forced vital capacity (FVC).
SecondaryInspiratory capacity at rest during CPETBaseline and after 28 days of each treatment periodChange in inspiratory capacity at rest measured during cardiopulmonary exercise testing (CPET).
SecondaryInspiratory capacity at isotime during CPETBaseline and after 28 days of each treatment periodChange in inspiratory capacity at isotime measured during cardiopulmonary exercise testing (CPET).
SecondaryInspiratory capacity at peak exercise during CPETBaseline and after 28 days of each treatment periodChange in inspiratory capacity at peak exercise measured during cardiopulmonary exercise testing (CPET).
SecondarySt. George's Respiratory Questionnaire (SGRQ) total scoreBaseline and after 28 days of each treatment period
Change in St. George's Respiratory Questionnaire (SGRQ) total score. Scores range from 0 to 100, with lower scores indicating better health-related quality of life and higher scores indicating worse health-related quality of life.
SecondaryDyspnoea intensity at isotime measured by the Modified Borg Dyspnoea ScaleBaseline and after 28 days of each treatment period
Change in dyspnoea intensity at isotime measured by the Modified Borg Dyspnoea Scale. Scores range from 0 to 10, with lower scores indicating less dyspnoea and higher scores indicating more severe dyspnoea.
SecondaryCOPD Assessment Test (CAT) total scoreBaseline and after 28 days of each treatment periodChange in COPD Assessment Test (CAT) total score. Scores range from 0 to 40, with lower scores indicating a better outcome and higher scores indicating a worse outcome.
SecondaryVeterans Specific Activity Questionnaire (VSAQ) scoreBaseline and after 28 days of each treatment periodChange in Veterans Specific Activity Questionnaire (VSAQ) score. Scores range from 1 to 13, with higher scores indicating greater exercise capacity.
SecondaryDuke Activity Status Index (DASI) total scoreBaseline and after 28 days of each treatment periodChange in Duke Activity Status Index (DASI) total score. Scores range from 0 to 58.2, with higher scores indicating better functional capacity.
SecondaryDyspnoea intensity at peak exercise measured by the Modified Borg Dyspnoea ScaleBaseline and after 28 days of each treatment period
Change in dyspnoea intensity at peak exercise measured by the Modified Borg Dyspnoea Scale. Scores range from 0 to 10, with lower scores indicating less dyspnoea and higher scores indicating more severe dyspnoea.
SecondaryModified Medical Research Council (mMRC) Dyspnoea Scale scoreBaseline and after 28 days of each treatment periodChange in Modified Medical Research Council (mMRC) Dyspnoea Scale score. Scores range from 0 to 4, with lower scores indicating less dyspnoea and higher scores indicating more severe dyspnoea.
OtherPlasma myostatin concentrationBaseline V1 and after each 28-day treatment periodEvaluation of circulating plasma myostatin levels as a biomarker of muscle metabolism and potential predictor of exercise capacity and treatment response in COPD patients.
OtherBody fat percentage assessed by bioelectrical impedance analysisBaseline V1 and after 28 days of each treatment periodChange in body fat percentage assessed by bioelectrical impedance analysis performed under standardized conditions.
OtherFat-free mass assessed by bioelectrical impedance analysisBaseline V1 and after 28 days of each treatment periodChange in fat-free mass assessed by bioelectrical impedance analysis performed under standardized conditions.
OtherSkeletal muscle mass assessed by bioelectrical impedance analysisBaseline V1 and after 28 days of each treatment periodChange in skeletal muscle mass assessed by bioelectrical impedance analysis performed under standardized conditions.
OtherVisceral fat level assessed by bioelectrical impedance analysisBaseline V1 and after 28 days of each treatment periodChange in visceral fat level assessed by bioelectrical impedance analysis performed under standardized conditions.

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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