Right Ventricular Response to Exercise Among Patients With Chronic Obstructive Pulmonary Disease (ReV UP COPD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Exercise; Pulmonary Hypertension; Exercise Training; COPD; Right Ventricular (RV) Dysfunction
• Intervention / Treatment: Behavioral: Exercise training

Detailed Description

This study will determine patterns of right ventricular (RV) response to aerobic exercise in patients with chronic obstructive pulmonary disease (COPD) and will design a targeted exercise intervention to improve RV response. We will study 60 patients with COPD. Participants will complete cardiopulmonary exercise testing (CPET) and transthoracic echocardiography (TTE) during rest, moderate- and high-intensity exercise. A subset of participants (n=16) who have been recommended to undergo clinical right heart catheterization will be recruited for the primary study with additional invasive pressure-volume analysis during the CPET. This testing will be used to validate measures of RV function obtained through noninvasive testing. The sample size was selected based upon our preliminary data and statistical analysis plans.

To test whether an exercise intervention targeted to RV response to exercise is feasible for patients, 12 participants will complete a targeted exercise training intervention based on their RV contractile response during baseline testing. This intervention will include participants who demonstrate RV contractility increase to moderate- but not high-intensity exercise. We will test the feasibility of a moderate-intensity interval training program. Participants will complete exercise training sessions 3x/week for 12 weeks. Exercise training will be performed on an upright stationary bicycle. Following the exercise training intervention, participants will repeat CPET and TTE. They will also complete a health-related quality of life questionnaire before and after the exercise training intervention.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lindsay Forbes, MD; Phone Number: (303)724-4020; Email: lindsay.forbes@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Contact: Lindsay Forbes, MD; Phone Number: 303-724-4020; Email: lindsay.forbes@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right ventricular contractility measured by transthoracic echocardiography	Global longitudinal strain, measured in absolute percent	Up to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right ventricular contractility measured by conductance catheter	Maximum rate of pressure change, dP/dtmax in mmHg/sec	Up to 1 hour
Maximum oxygen consumption (VO2max)	In L/min	Up to 1 hour
Health-related quality of life by Short Form 36 (SF-36) questionnaire	Units, range 0-100 with greater scores indicating a more favorable health state	Up to 1 hour
Exercise training feasibility	Proportion of exercise training sessions completed	4 months
Exercise training safety	Adverse events, reported or observed	4 months
Right ventricular systolic function measured by transthoracic echocardiography	Fractional area change on transthoracic echocardiography, measured in percent	Up to 1 hour
Right ventricular systolic function measured by transthoracic echocardiography	Tricuspid annular plane systolic excursion on transthoracic echocardiography, measured in centimeters	Up to 1 hour

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Lindsay Forbes, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; COPD; Pulmonary hypertension; Pulmonary rehabilitation; Exercise training
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Hypertension; Pathological Conditions, Signs and Symptoms; Behavior; Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 23-0516b; K23HL175186 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No