Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT07576894

Conditions

COPD

Pulmonary Hypertension

Exercise

Right Ventricular (RV) Dysfunction

Exercise Training

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Exercise training

Study Details

Brief summary:

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.

Conditions

COPD

Pulmonary Hypertension

Exercise

Right Ventricular (RV) Dysfunction

Exercise Training

Study ID

NCT07576894

Start date

Aug 1, 2025

Status verified date

May, 2026

Completion date

Aug 1, 2030

Anticipated

Primary completion date

May 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: COPD

Participants will complete testing at rest and during moderate- and high-intensity exercise to identify patterns of right ventricular responses. Participants who based on baseline testing are eligible and decide to participate in the optional exercise training program will complete exercise training followed by repeat testing to determine the impact of exercise training on right ventricular dysfunction.

Interventions

Exercise training

Exercise training will include moderate-intensity interval training 3x/week.

Primary outcome measure

  • Right ventricular contractility measured by transthoracic echocardiography [ Time Frame: Up to 1 hour ]

Central Contacts and Locations

Central contacts

Lindsay Forbes, MD

(303)724-4020lindsay.forbes@cuanschutz.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Lindsay Forbes, MD

303-724-4020lindsay.forbes@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • COPD
  • Pulmonary hypertension
  • Exercise
  • Pulmonary rehabilitation
  • Exercise training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-05-08.