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

NCT05896579 | Recruiting DMC

• 2 other identifiers: 23-0516K23HL175186
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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; Right Ventricular Dysfunction; Exercise; Exercise Training

Outcome Measures

Primary Outcomes (1)

• Right ventricular contractility measured by transthoracic echocardiography

  Global longitudinal strain, measured in absolute percent

  Up to 1 hour

Secondary Outcomes (7)

• Right ventricular contractility measured by conductance catheter

  Up to 1 hour

• Right ventricular systolic function measured by transthoracic echocardiography

  Up to 1 hour

• Right ventricular systolic function measured by transthoracic echocardiography

  Up to 1 hour

• Exercise training feasibility

  4 months

• Exercise training safety

  4 months

Study Arms (1)

COPD

EXPERIMENTAL

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

Interventions

Exercise training BEHAVIORAL

Exercise training will include moderate-intensity interval training for \~35 minutes 3x/week and light-intensity continuous aerobic exercise for \~25 minutes 2x/week.

COPD

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity \[FEV1/FVC\] \<0.7) • Age \>= 40 years

You may not qualify if:

• Exacerbation of COPD or use of systemic corticosteroids 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%; arrhythmia; pulmonic, mitral or aortic valvular abnormality greater than mildin severity; tricuspid regurgitation greater than moderate in severity; diabetes with HbA1c \>8.5%)
• 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
• Interstitial lung disease thought to be primary etiology of pulmonary hypertension
• Untreated severe obstructive sleep apnea or obesity hypoventilation syndrome
• Active malignancy (other than skin)
• Medical conditions that limit exercise on an upright stationary bicycle (e.g. osteoarthritis, imbalance/gait instability, etc.)
• Pregnancy
• Body mass index \<18 or \>35
• Hematocrit \<25% or \>55%

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Ventricular Dysfunction, Right; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Heart Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lindsay Forbes, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay Forbes, MD

CONTACT

(720)892-6017; lindsay.forbes@cuanschutz.edu

William Cornwell, MD, MSCS

CONTACT

william.cornwell@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study participants will undergo testing to identify patterns of right ventricular response to moderate- vs high-intensity exercise. If a study participant decides to participate in exercise training, the participant will complete an exercise training intervention followed by repeat testing to determine impact of exercise training on right ventricular dysfunction.

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 9, 2023
• Study Start: August 22, 2023
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)