36 Participants Needed

Exercise Training for Right Ventricular Dysfunction in COPD

LF
WC
Overseen ByWilliam Cornwell, MD, MSCS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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 to pulmonary hypertension (high pressure in the lungs) during rest and exercise. By identifying patterns of right ventricular dysfunction, this study will help identify better treatments for patients with COPD in the future.

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.

Is exercise training safe for people with COPD?

Exercise training is generally safe for people with COPD, even those with other health issues, and it can lead to significant improvements in exercise capacity and quality of life. Although few studies have looked at the negative effects, the overall balance of benefits and risks is favorable.12345

How does exercise training differ from other treatments for right ventricular dysfunction in COPD?

Exercise training is unique because it directly targets the improvement of exercise tolerance and right ventricular function through physical activity, rather than relying on medication. It is a key component of pulmonary rehabilitation, which is a standard care approach for COPD, and has been shown to improve both exercise performance and quality of life by addressing the underlying muscle dysfunction and breathlessness associated with the condition.25678

What data supports the effectiveness of the treatment Exercise training for Right Ventricular Dysfunction in COPD?

Exercise training is shown to improve exercise capacity, reduce breathlessness, and enhance quality of life in patients with COPD, even though their lung function remains unchanged. It is a key part of pulmonary rehabilitation, helping patients manage symptoms and improve their overall health.123910

Who Is on the Research Team?

LF

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.
I have a condition that prevents me from exercising on a bike.
See 12 more

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?
1Treatment groups
Experimental Treatment
Group I: COPD with pulmonary artery enlargementExperimental Treatment1 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.

Find a Clinic Near You

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.
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]
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.
Exercise training in chronic obstructive pulmonary disease.Rochester, CL.[2019]
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.
The roles of bronchodilators, supplemental oxygen, and ventilatory assistance in the pulmonary rehabilitation of patients with chronic obstructive pulmonary disease.ZuWallack, RL.[2008]

Citations

Right ventricular systolic dysfunction is related to exercise intolerance in patients with chronic obstructive pulmonary disease. [2016]
Exercise training in chronic obstructive pulmonary disease. [2019]
The roles of bronchodilators, supplemental oxygen, and ventilatory assistance in the pulmonary rehabilitation of patients with chronic obstructive pulmonary disease. [2008]
Athletic training in chronic obstructive pulmonary disease. [2008]
COPD and exercise: does it make a difference? [2023]
COPD: benefits of exercise training. [2016]
Developing the model of pulmonary rehabilitation for chronic heart failure. [2011]
Effects of exercise training on pulmonary vessel muscularization and right ventricular function in an animal model of COPD. [2021]
Generic, symptom based, exercise rehabilitation; integrating patients with COPD and heart failure. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Right ventricular dysfunction and the exercise limitation of chronic obstructive pulmonary disease. [2019]
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