Exercise Training for Right Ventricular Dysfunction in COPD

Overseen By William Cornwell, MD, MSCS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Systemic corticosteroids

Disqualifiers: Cardiovascular disease, Diabetes, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercise training can improve heart function in people with chronic obstructive pulmonary disease (COPD) and high blood pressure in their lungs. Researchers aim to understand how the right side of the heart responds to these conditions during rest and exercise. Participants will undergo tests to identify heart function patterns and may choose to join a structured exercise program. Those with long-standing COPD and enlarged pulmonary arteries may qualify for this trial if they haven't recently changed treatments or experienced serious heart issues. As an unphased study, this trial offers a unique opportunity to advance understanding of heart health in COPD patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have changed your COPD therapy in the 3 weeks before joining. If you are using systemic corticosteroids, you must not have used them in the 3 months before joining.

What prior data suggests that exercise training is safe for individuals with COPD?

Research has shown that exercise is generally safe for people with chronic obstructive pulmonary disease (COPD). One study found that starting a program of exercise and education, known as pulmonary rehabilitation, after a hospital stay is both safe and helpful. Another study found that various types of exercise, such as high-intensity interval training, can improve lung function and quality of life for people with COPD. These findings suggest that individuals with this condition can tolerate exercise well and benefit from it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for COPD, which often focus on medications like bronchodilators and steroids to manage symptoms, exercise training targets the heart directly. Researchers are excited about this approach because it aims to improve right ventricular function, specifically in patients with pulmonary artery enlargement. This could enhance overall heart health and physical capacity, potentially offering benefits that medications alone can't provide.

What evidence suggests that exercise training is effective for right ventricular dysfunction in COPD?

Studies have shown that exercise can greatly benefit people with COPD (chronic obstructive pulmonary disease). It enhances muscle strength and reduces swelling, common issues in COPD. Research indicates that regular exercise helps individuals with this condition become more active and improve their exercise capacity. Exercise is strongly recommended for those with long-term lung and heart problems. In this trial, participants with COPD and pulmonary artery enlargement may opt to join an exercise training program to assess its impact on right ventricular dysfunction. This suggests that exercise could effectively boost heart and lung health in people with COPD. ^{2 3 6 7 8}

Who Is on the Research Team?

Lindsay Forbes, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults with COPD, confirmed by specific lung function tests and signs of pulmonary artery enlargement. Participants should not have had a recent COPD flare-up or changes in treatment, must be able to exercise on a bike, and not already doing regular intense workouts. They can't join if they have severe heart issues, untreated sleep apnea, extreme body weight, certain blood conditions or are pregnant.

Inclusion Criteria

My heart scans show pulmonary artery enlargement not during a COPD flare-up.

COPD determined by ratio of forced expiratory volume in 1 second to forced vital capacity [FEV1/FVC] <0.7

Exclusion Criteria

I have sleep apnea that has not been treated.

I haven't had a severe COPD flare-up or used steroids in the last 3 months.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing at Rest and During Exercise

Participants will complete testing at rest and during exercise to identify patterns of right ventricular dysfunction

Up to 1 hour per session

Multiple sessions

Exercise Training Program (Optional)

Participants may opt into an exercise training program followed by repeat testing to determine the impact on right ventricular dysfunction

4 months

Regular sessions over 4 months

Follow-up

Participants are monitored for safety and effectiveness after the exercise training program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise training

Trial Overview

The study focuses on how the right side of the heart functions in people with COPD when facing high lung pressure at rest and during exercise. It aims to uncover patterns of dysfunction that could lead to improved treatments for these patients.

How Is the Trial Designed?

Group I: COPD with pulmonary artery enlargement Experimental Treatment 1 Intervention

Participants will complete testing at rest and during exercise to identify patterns of right ventricular dysfunction. If a participant decides to participate in the optional exercise training program, the participant will complete exercise training followed by repeat testing to determine the impact of exercise training on right ventricular dysfunction.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

In a study of 44 COPD patients undergoing a 4-week exercise training program, those with right ventricular dysfunction (TAPSE ≤16 mm) had significantly lower exercise tolerance, as measured by the 6-minute walk test (6MWT), compared to those without dysfunction.

While both groups improved their walking distance after training, the increase was less pronounced in patients with right ventricular dysfunction (+24.3% vs +32.8%), indicating that right ventricular function is an important factor in exercise capacity and rehabilitation outcomes in COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Right ventricular systolic dysfunction is related to exercise intolerance in patients with chronic obstructive pulmonary disease. Caminiti, G., Cardaci, V., Conti, V., et al.[2016]

In a study of 26 patients with chronic obstructive pulmonary disease (COPD), a significant correlation was found between oxygen consumption during maximal exercise and right ventricular ejection fraction, indicating that better heart function is linked to improved exercise capacity.

The change in right ventricular ejection fraction during exercise was inversely related to total pulmonary resistance, suggesting that exercise limitations in COPD patients are influenced by both heart function and lung resistance, highlighting the complex interaction between these systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Right ventricular dysfunction and the exercise limitation of chronic obstructive pulmonary disease. Morrison, DA., Adcock, K., Collins, CM., et al.[2019]

Structured exercise training significantly improves functional exercise capacity and health status in patients with COPD, even when they have comorbid conditions, without affecting resting lung function.

Exercise training is essential in pulmonary rehabilitation for COPD patients, as it enhances muscle function and exercise tolerance, making a meaningful difference in their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COPD and exercise: does it make a difference? Spruit, MA., Burtin, C., De Boever, P., et al.[2023]

Exercise training significantly improves exercise performance and quality of life for patients with both chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF), addressing common symptoms like breathlessness and fatigue.

Incorporating CHF patients into pulmonary rehabilitation (PR) programs, which are standard for COPD, could enhance access to exercise rehabilitation and provide effective treatment, as both conditions share similar symptoms and can be trained together safely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing the model of pulmonary rehabilitation for chronic heart failure. Evans, RA.[2011]

Pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD) significantly improves symptoms like shortness of breath (dyspnea), exercise capacity, and overall quality of life, as well as reducing healthcare resource use.

The effectiveness of exercise training during rehabilitation can be enhanced by using bronchodilators, supplemental oxygen, and noninvasive ventilatory support, allowing patients to train at higher intensities for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The roles of bronchodilators, supplemental oxygen, and ventilatory assistance in the pulmonary rehabilitation of patients with chronic obstructive pulmonary disease. ZuWallack, RL.[2008]

Exercise training programs can significantly improve work capacity in patients with chronic obstructive pulmonary disease (COPD), even among those with severe symptoms.

In addition to physical benefits, exercise training helps reduce emotional issues such as anxiety, depression, and social isolation commonly experienced by COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Athletic training in chronic obstructive pulmonary disease. Shayevitz, MB., Shayevitz, BR.[2008]

Exercise training significantly improves exercise capacity and quality of life in patients with chronic obstructive pulmonary disease (COPD), with benefits lasting up to 2 years after 8 to 12 weeks of training.

Both high- and low-intensity exercise enhance endurance, but only high-intensity training improves aerobic fitness, highlighting the importance of tailored exercise programs in pulmonary rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in chronic obstructive pulmonary disease. Rochester, CL.[2019]

General exercise training significantly improves quality of life in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD) compared to standard care without pulmonary rehabilitation.

After a COPD exacerbation, exercise training can reduce the risk of hospitalization by at least 50% in the following months, and the overall harm-benefit balance of exercise training in COPD appears favorable based on available data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COPD: benefits of exercise training. [2016]

A study involving 57 patients with Chronic Heart Failure (CHF) showed that a 7-week exercise rehabilitation (ER) program significantly improved walking distance and health status compared to usual care, with improvements similar to those seen in patients with Chronic Obstructive Pulmonary Disease (COPD).

The results suggest that combined exercise rehabilitation programs for patients with CHF and COPD are effective and feasible, indicating a potential for integrated treatment approaches that focus on common symptoms rather than just the underlying diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Generic, symptom based, exercise rehabilitation; integrating patients with COPD and heart failure. Evans, RA., Singh, SJ., Collier, R., et al.[2022]

In a study involving 42 female mice exposed to cigarette smoke, high intensity interval training (HIIT) was found to reverse right ventricular (RV) dysfunction caused by smoke exposure, indicating its potential as a therapeutic intervention for heart issues related to COPD.

HIIT also led to reduced muscularization of pulmonary blood vessels, suggesting that exercise can positively impact both heart function and the health of the pulmonary vasculature in the context of COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise training on pulmonary vessel muscularization and right ventricular function in an animal model of COPD. Hassel, E., Berre, AM., Skjulsvik, AJ., et al.[2021]

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