Exercise Training for Pulmonary Arterial Hypertension

Overseen By Yogesh Reddy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Heart failure, Anemia, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The investigators are doing this research study to compare whole body aerobic training with isolated leg training (with weights) and its impact on effectiveness in symptoms and quality of life in patients with Pulmonary Arterial Hypertension (PAH).

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should not have started a new pulmonary vasodilator in the last 60 days.

Is exercise training safe for people with pulmonary arterial hypertension?

Exercise training for people with pulmonary arterial hypertension has been shown to have an acceptable safety profile in several studies, with benefits like improved symptoms and quality of life. However, it's important that these programs are conducted by experienced centers to ensure safety. ^{1 2 3 4 5}

How does exercise training differ from other treatments for pulmonary arterial hypertension?

Exercise training for pulmonary arterial hypertension is unique because it is a non-drug therapy that focuses on improving physical fitness and quality of life through aerobic and leg exercises. Unlike traditional drug treatments, it helps enhance muscle function and cardiorespiratory fitness, offering a complementary approach to medical therapy. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment Aerobic Training, Aerobic Exercise, Cardiovascular Exercise, Physical Activity Therapy, Leg Training for Pulmonary Arterial Hypertension?

Research shows that specialized exercise programs can improve symptoms, exercise capacity, and quality of life in patients with pulmonary arterial hypertension. These programs have been found to be safe and beneficial when added to medical treatment, although the best methods and duration are still being studied. ^{2 4 7 8 9}

Who Is on the Research Team?

Yogesh Reddy, M.B.B.S

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with Pulmonary Arterial Hypertension (PAH) who are stable, not hospitalized recently, and haven't started new PAH drugs in the last 60 days. Healthy individuals without heart failure can also join as controls. Exclusions include recent severe cardiovascular events, inability to exercise, need for oxygen supplementation, pregnancy or potential pregnancy without effective contraception.

Inclusion Criteria

Criterion Summary: For patients with Pulmonary Arterial Hypertension (PAH): - You have given consent to participate in the trial. - You are in NYHA Class II-IV. - Your Left Ventricular Ejection Fraction (LVEF) is equal to or greater than 40% in the past year. - You have not been hospitalized due to heart failure in the last 30 days. - You have not started a new pulmonary vasodilator in the last 60 days. - Your mean Pulmonary Arterial (PA) pressure is equal to or greater than 20 mmHg with Pulmonary Vascular Resistance (PVR) greater than 2 Wood units, as determined by right heart catheterization. - Your exercise Pulmonary Capillary Wedge Pressure (PCWP) is less than 25 mm Hg. - You are symptomatic with PAH and planning to undergo exercise right heart catheterization for reassessment of exertional symptoms. For healthy controls: - You have given consent to participate in the trial. - You do not have a known diagnosis of heart failure.

Exclusion Criteria

You have experienced a heart attack, stroke, or heart-related hospitalization in the last 30 days, or you have certain heart conditions that could cause difficulty in breathing or exercising. You are unable to walk without assistance, have chronic low oxygen levels, have certain muscle or bone conditions, or have been involved in certain medical trials recently. You are pregnant, breastfeeding, or planning to become pregnant, or you have a severe psychiatric disorder, have had recent suicidal behavior, or are suspected of drug abuse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline study assessments before randomization

1 week

Treatment

Participants undergo either aerobic training or leg training for 12 weeks

12 weeks

Follow-up

Participants are monitored for changes in skeletal muscle O2 diffusive conductance and quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Training
• Leg Training

Trial Overview The study compares two types of physical training: whole body aerobic exercises versus targeted leg strength training. It aims to determine which method better improves symptoms and life quality in PAH patients.

How Is the Trial Designed?

Group I: Leg Training Experimental Treatment 1 Intervention

Subjects with PAH will be enrolled to complete baseline study assessments, be randomized to undergo leg training for 12 weeks, and then repeat study assessments.

Group II: Aerobic Training Active Control 1 Intervention

Subjects with PAH will be enrolled to complete baseline study assessments, be randomized to undergo aerobic training for 12 weeks, and then repeat study assessments.

Group III: Healthy Controls Active Control 1 Intervention

Healthy controls will be enrolled to complete the baseline study assessments for generation of normal reference values for comparison. Healthy controls will not undergo randomized exercise training interventions or repeat assessments.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study of 18 women with pulmonary arterial hypertension (PAH) undergoing 10 weeks of vigorous aerobic exercise training, significant improvements were observed in cardiac function, including a decrease in systemic vascular resistance at peak exercise, suggesting enhanced heart efficiency.

The study found that vigorous aerobic exercise did not lead to declines in left ventricular function, indicating that such training may be safe and beneficial for women with PAH by potentially reducing afterload and preserving diastolic function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left Ventricular Function Before and After Aerobic Exercise Training in Women With Pulmonary Arterial Hypertension. Woolstenhulme, JG., Guccione, AA., Herrick, JE., et al.[2023]

In a study of 25 females with pulmonary hypertension undergoing a 10-week aerobic exercise training program, significant improvements in cardiorespiratory function were observed in those with high (HI) and low (LI) increases in 6-minute walk test distance, but not in those with negative (NEG) adaptations.

The HI group showed notable enhancements in ventilatory efficiency and other key respiratory metrics post-training, suggesting that some patients may struggle with exercise adaptation due to sustained ventilatory inefficiency, which could limit their exercise capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiopulmonary exercise test indices of respiratory buffering before and after aerobic exercise training in women with pulmonary hypertension: Differentiation by magnitudes of change in six-minute walk test performance. Morris, ZV., Chin, LMK., Chan, L., et al.[2023]

A specialized exercise training and rehabilitation program is recommended as an effective add-on treatment for patients with pulmonary arterial hypertension, showing significant improvements in symptoms, exercise capacity, and quality of life across over 470 patients in various studies.

The safety profile of these exercise programs is acceptable, with some studies indicating excellent survival rates over 1 to 2 years, although most studies had small sample sizes and were not designed to measure long-term clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Principles of rehabilitation and reactivation: pulmonary hypertension. Marra, AM., Egenlauf, B., Bossone, E., et al.[2015]

A 4-week cardiorespiratory training program for 15 patients with pulmonary arterial hypertension (PAH) significantly improved their exercise capacity, as shown by an 8% increase in the 6-minute walk test distance and a 22% increase in workload during cardiopulmonary exercise testing.

The training program also enhanced the patients' quality of life, with significant reductions in anxiety and depression scores, and no adverse events were reported, indicating the program's safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an Outpatient Service Rehabilitation Programme in Patients Affected by Pulmonary Arterial Hypertension: An Observational Study. Bussotti, M., Gremigni, P., Pedretti, RFE., et al.[2022]

A 6-week outpatient exercise training program significantly improved exercise tolerance and health-related quality of life in two individuals with pulmonary arterial hypertension (PAH), with no adverse effects reported.

Both subjects showed notable increases in oxygen consumption and distance walked in the six-minute walk test, indicating enhanced aerobic capacity and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in patients with pulmonary arterial hypertension: a case report. Shoemaker, MJ., Wilt, JL., Dasgupta, R., et al.[2021]

Aerobic exercise training is beneficial for patients with pulmonary arterial hypertension as it helps improve skeletal muscle function and exercise tolerance, addressing issues like muscle myopathy and atrophy.

The review discusses how aerobic exercise leads to positive changes in muscle through mechanisms such as reduced inflammation, enhanced anabolic processes, and better mitochondrial function, although the exact pathways are still being explored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skeletal muscle dysfunctions in pulmonary arterial hypertension: Effects of aerobic exercise training. Drummond, FR., Leite, LB., de Miranda, DC., et al.[2023]

Regular exercise training has been shown to be safe and effective in improving quality of life and cardiorespiratory fitness in patients with pulmonary arterial hypertension (PAH), despite the limited number of studies available.

Emerging evidence suggests that specific training recommendations can be developed to enhance rehabilitation programs for PAH patients, addressing their unique physiological challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Exercise Interventions in Pulmonary Arterial Hypertension and Recommendations for Rehabilitation Programing. Ozemek, C., Berry, MJ., Arena, R.[2020]

An 8-month exercise intervention in patients with pulmonary arterial hypertension (PH) showed improvements in physical capacity, NT-proBNP levels, physical activity, and quality of life, indicating the potential benefits of exercise in managing this condition.

The study provides detailed pre and post-intervention data categorized by New York Heart Association (NYHA) class, enhancing our understanding of how exercise impacts different severity levels of PH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an 8-month exercise intervention on physical capacity, NT-proBNP, physical activity levels and quality of life data in patients with pulmonary arterial hypertension by NYHA class. Santos-Lozano, A., Sanz-Ayan, P., González-Saiz, L., et al.[2020]

Historically, exercise training was not recommended for patients with pulmonary hypertension due to concerns about safety and potential drops in cardiac output during exertion.

Recent evidence suggests that exercise training is safe and effective for improving exercise capacity, peak oxygen consumption, and quality of life in pulmonary hypertension patients, indicating it should be included as part of their treatment plan alongside optimal medical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary hypertension and exercise training: a synopsis on the more recent evidences. Leggio, M., Fusco, A., Armeni, M., et al.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Left Ventricular Function Before and After Aerobic Exercise Training in Women With Pulmonary Arterial Hypertension. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Cardiopulmonary exercise test indices of respiratory buffering before and after aerobic exercise training in women with pulmonary hypertension: Differentiation by magnitudes of change in six-minute walk test performance. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Principles of rehabilitation and reactivation: pulmonary hypertension. [2015]

4. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Effects of an Outpatient Service Rehabilitation Programme in Patients Affected by Pulmonary Arterial Hypertension: An Observational Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Exercise training in patients with pulmonary arterial hypertension: a case report. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Skeletal muscle dysfunctions in pulmonary arterial hypertension: Effects of aerobic exercise training. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A Review of Exercise Interventions in Pulmonary Arterial Hypertension and Recommendations for Rehabilitation Programing. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of an 8-month exercise intervention on physical capacity, NT-proBNP, physical activity levels and quality of life data in patients with pulmonary arterial hypertension by NYHA class. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Pulmonary hypertension and exercise training: a synopsis on the more recent evidences. [2019]