No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
40 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for individuals with chronic obstructive pulmonary disease (COPD) to study how their heart responds during rest and exercise. Taking part involves testing heart function while exercising at different intensity levels.
Are You a Good Fit for This Trial?
Rules you outPulmonary hypertensionActive malignancySevere osteoarthritis
You may be able to join if
I have been diagnosed with COPD
I am 40 years or older
You may not be able to join if
I have had a COPD flare-up in the last 3 months
I have changed my COPD medications in the last 3 weeks
I need more than 6 liters of oxygen at rest
I need more than 10 liters of oxygen when I exercise
I have uncontrolled heart disease
I have severe sleep apnea or obesity hypoventilation syndrome
I am pregnant
I am engaged in regular exercise training
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study plans to learn more about heart function among individuals with chronic obstructive pulmonary disease (COPD). In particular, the investigators want to understand the different patterns of right ventricular response during rest and moderate- vs high-intensity exercise. By identifying patterns of right ventricular dysfunction, this study will help identify better treatments for patients w…
This study plans to learn more about heart function among individuals with chronic obstructive pulmonary disease (COPD). In particular, the investigators want to understand the different patterns of right ventricular response during rest and moderate- vs high-intensity exercise. By identifying patterns of right ventricular dysfunction, this study will help identify better treatments for patients with COPD in the future.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity \[FEV1/FVC\] \<0.7)
* Age \>= 40 years
Exclusion Criteria:
* Exacerbation of COPD in the 3 months prior to enrollment
* Change in COPD therapy in the 3 weeks prior to enrollment
* Requ…
Inclusion Criteria:
* COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity \[FEV1/FVC\] \<0.7)
* Age \>= 40 years
Exclusion Criteria:
* Exacerbation of COPD in the 3 months prior to enrollment
* Change in COPD therapy in the 3 weeks prior to enrollment
* Requirement of \>6 LPM supplemental oxygen at rest
* Requirement of \>10 LPM supplemental oxygen with exertion
* Active/uncontrolled cardiovascular disease (e.g. hypertension with blood pressure \>150/100 despite antihypertensives; coronary artery disease with angina; left ventricular ejection fraction ≤40%; uncontrolled arrhythmia; pulmonic, mitral or aortic valvular abnormality greater than mild in severity; tricuspid regurgitation greater than moderate in severity)
* Volume overload (jugular vascular distension or greater than trace peripheral edema)
* World Health Organization Functional Class IV
* Known pulmonary hypertension with mean pulmonary artery pressure \>45 mmHg
* Untreated severe obstructive sleep apnea and/or obesity hypoventilation syndrome
* Active malignancy (other than skin)
* Medical conditions that limit exercise on an upright stationary bicycle (e.g. severe osteoarthritis, imbalance/gait instability, etc.)
* Pregnancy
* Body mass index \<18 or \>35
* Hematocrit \<25% or \>55%
* For subset undergoing right heart catheterization, chronic anticoagulation that is unable to be held for the study visit
* For subset undergoing right heart catheterization or exercise training, forced expiratory volume in 1 second of \<20%
* For exercise training, already engaged in routine exercise training (\>30 minutes at \>3 METs 3 times/week or more)
* For exercise training, inability to complete initial in-person exercise training sessions for approximately 35 minutes 3x/week for 3 weeks (followed by exercise training sessions with an option for hybrid remote/in-person participation)
* For exercise training with an option for hybrid remote exercise training, any medical conditions which threaten the safety of remote exercise training (e.g. imbalance/gait instability, etc.).
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