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Right Ventricular Response to Exercise Among Patients With Chronic Obstructive Pulmonary Disease

Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will complete exercise training sessions 3x/week for 12 weeks."
  • "They will also complete a health-related quality of life questionnaire before and after the exercise training intervention."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how the heart’s right pumping chamber works at rest and during moderate and hard exercise. It is for adults age 40 or older with COPD, a lung disease that makes breathing hard.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 40 or older.
  • Have COPD confirmed by a breathing test called FEV1/FVC, with a result below 0.7.

Who can't join

  • A COPD flare-up in the past 3 months or a change in COPD treatment in the past 3 weeks. Also excluded: needing more than 6 liters of oxygen per minute at rest or more than 10 during activity.
  • Active or uncontrolled heart or blood vessel disease. Examples include blood pressure above 150/100 despite medicine; blocked heart arteries with chest pain; a left heart pumping strength of 40% or less; an uncontrolled uneven heartbeat; or certain heart valve problems.
  • Too much fluid in the body, shown by swollen neck veins or more than slight swelling in the arms or legs; WHO Class IV symptoms, meaning symptoms at rest and trouble with any physical activity; or known high blood pressure in the lungs with an average pressure above 45 mmHg.
  • Untreated severe sleep apnea, which causes breathing pauses during sleep, or untreated shallow breathing linked to obesity. Also excluded: active cancer other than skin cancer, or pregnancy.
  • Body mass index (BMI), a measure of weight compared with height, below 18 or above 35. Also excluded: hematocrit, the share of blood made up of red blood cells, below 25% or above 55%.
  • A health problem that limits riding an upright exercise bike, such as severe joint disease or poor balance. For remote exercise training, any health problem that makes exercising remotely unsafe also excludes you.
  • For people having a right heart catheter test, which uses a thin tube to measure heart pressures: taking long-term blood thinners that cannot be paused for the study visit. For this test or exercise training: an FEV1 breathing test result below 20%.
  • For exercise training: already exercising for more than 30 minutes at an effort above 3 METs, at least 3 times a week. METs measure how hard your body works. Also excluded: being unable to attend the first in-person sessions for about 35 minutes, 3 times a week for 3 weeks. Later sessions may combine remote and in-person training.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 * 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.).

Study sites (1)

CO