Nutrition and Exercise for Pulmonary Arterial Hypertension

Overseen By Chazity Bush

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Must be taking: PAH-targeted therapy

Disqualifiers: Diabetes, Heart disease, Lung disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how diet and exercise might help people with pulmonary arterial hypertension (PAH) by improving insulin sensitivity. Better glucose metabolism, or how the body uses sugar for energy, could benefit those with PAH. Participants will either follow a plan with moderate exercise and a special diet or receive standard diet and exercise advice. People with PAH who are currently on stable medication and have not experienced severe heart issues recently might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding lifestyle impacts on PAH.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires that you have been on a stable dose of PAH-targeted therapy and diuretics for at least 2 months before joining.

What prior data suggests that this nutrition and exercise protocol is safe for PAH patients?

Research shows that exercise is generally safe for people with pulmonary hypertension, a type of high blood pressure affecting the lungs. Studies have found that exercise can significantly improve exercise capacity and enhance overall quality of life for these patients. No major safety issues have been reported with exercise for these individuals.

Regarding diet, consuming foods with a low glycemic index and following a Mediterranean Diet have not been linked to any negative effects. This type of diet can improve heart health and help manage weight.

Overall, combining exercise with this specific diet appears well-tolerated by people with pulmonary arterial hypertension, with no significant safety concerns reported in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nutrition and Exercise approach for Pulmonary Arterial Hypertension because it combines moderate exercise with a specific dietary focus, which is a fresh take compared to traditional treatments. Most current options focus on medication to manage symptoms and improve heart function. However, this new approach emphasizes lifestyle changes, offering a non-pharmacological method that could enhance overall health and quality of life. By focusing on a Low Glycemic Index/Mediterranean Diet and regular exercise, it aims to address the condition through improved metabolic health, which is not the primary focus of standard treatments. This holistic approach could provide a complementary strategy alongside existing medical therapies.

What evidence suggests that nutrition and exercise might be an effective treatment for pulmonary arterial hypertension?

Research has shown that exercise can significantly enhance exercise capacity, fitness levels, and overall quality of life for individuals with pulmonary hypertension (high blood pressure in the lungs). Studies have found a link between increased physical activity and better results on a 6-minute walk test, as well as higher quality of life scores for those with pulmonary arterial hypertension (PAH). A healthy diet might also help prevent the worsening of PAH symptoms. This trial will compare a regimen of nutrition and exercise, which includes 5 days a week of moderate exercise and biweekly diet counseling on a Low Glycemic Index/Mediterranean Diet, with standard care. Although modern treatments for PAH exist, they are not perfect, so combining good nutrition and exercise could greatly benefit patients. ^{1 2 4 5 6}

Who Is on the Research Team?

Raed Dweik, MD

Principal Investigator

The Cleveland Clinic

Gustavo Heresi, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with Group 1 Pulmonary Arterial Hypertension (PAH), including various subtypes, who are stable on current medications. It's not suitable for those with severe PAH symptoms, diabetes, heart issues like ischemia or uncontrolled arrhythmias, high oxygen needs (>4 LPM), recent fainting episodes, or other specific lung and systemic diseases.

Inclusion Criteria

I have Group 1 PAH, which may be related to a genetic condition, drug use, or another disease.

My diuretic dose and oxygen support have been stable for the last 2 months.

My heart condition mildly or moderately affects my daily activities.

Exclusion Criteria

I have high blood pressure in my lungs caused by lung disease and low oxygen levels.

I have high blood pressure in my lungs due to a blood disorder or sarcoidosis.

I need more than 4 liters per minute of oxygen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in 5 days a week of moderate exercise and biweekly diet counseling on Low Glycemic Index/ Mediterranean Diet for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Nutrition and Exercise

Trial Overview The PHINE study is testing whether a special diet and exercise program can improve the health of people with PAH by helping their bodies use insulin better. The idea is that changing how the body handles sugar might help ease the strain on blood vessels in the lungs.

How Is the Trial Designed?

Group I: Nutrition and Exercise Experimental Treatment 1 Intervention

5 days a week of moderate exercise and biweekly diet counseling on Low Glycemic Index/ Mediterranean Diet for 12 weeks.

Group II: Standard of Care Active Control 1 Intervention

Counseling at baseline on diet as recommended by USDA and on the benefits of regular aerobic exercise.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

A study involving 8 congenital heart disease patients with pulmonary hypertension showed that a 3-month directed exercise rehabilitation program was safe and did not lead to any adverse events, such as worsening symptoms or heart failure.

Patients who participated in the rehabilitation program demonstrated improvements in their 6-minute walk test and functional class, indicating that structured exercise can be beneficial for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation program in adult congenital heart disease patients with pulmonary hypertension. Martínez-Quintana, E., Miranda-Calderín, G., Ugarte-Lopetegui, A., et al.[2022]

This randomized controlled trial will assess the effects of an 8-week exercise program on muscle power and mass in patients with pulmonary artery hypertension (PAH), involving at least 48 participants.

The study aims to evaluate various health outcomes, including exercise capacity and quality of life, which will help understand the benefits of exercise in managing PAH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and Design of a Randomized Controlled Trial Evaluating Whole Muscle Exercise Training Effects in Outpatients with Pulmonary Arterial Hypertension (WHOLEi+12). Sanchis-Gomar, F., González-Saiz, L., Sanz-Ayan, P., et al.[2022]

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]

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]

A 12-week text message-based intervention significantly increased daily step counts in patients with pulmonary arterial hypertension (PAH), with an average increase of 1,409 steps compared to a decrease of 149 steps in the control group.

The intervention also led to improvements in quality of life and reductions in visceral fat, suggesting that mobile health strategies can effectively promote physical activity in PAH patients, although no significant change was observed in the six-minute walk test.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Health Intervention to Increase Physical Activity in Pulmonary Arterial Hypertension. Hemnes, AR., Silverman-Lloyd, LG., Huang, S., et al.[2022]

In a study of 108 patients with pulmonary arterial hypertension (PAH), the use of actigraphy to measure daily life physical activity (DLPA) showed that selexipag did not lead to significant improvements in physical activity levels compared to placebo over 24 weeks.

Despite high compliance with the accelerometer, changes in daily physical activity were small and variable, indicating that selexipag may not have a meaningful impact on improving quality of life through increased physical activity in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Daily Life Physical Activity by Actigraphy in Pulmonary Arterial Hypertension: Insights From the Randomized Controlled Study With Selexipag (TRACE). Howard, LS., Rosenkranz, S., Frantz, RP., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7019983/

Impact of Nutrition on Pulmonary Arterial Hypertension - PMC After four weeks of iron deficient diet, rats present vascular remodeling in resistance pulmonary arteries and PAH.

2. clinicaltrials.gov clinicaltrials.gov/ct2/keydates/NCT03288025

Pulmonary Arterial Hypertension Improvement With ... Even with modern PAH therapies, current outcomes remain poor, with an estimated 3-year survival rate of only 55%. Thus, there is a clear need for more effective ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7330286/

Effectiveness and safety of exercise training ... Exercise training is associated with a significant improvement in exercise capacity, cardiorespiratory fitness and quality of life among patients with PH

4. clinicaltrial.be clinicaltrial.be/en/details/8353?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Pulmonary Arterial Hypertension Improvement With Nutritio... Even with modern PAH therapies, current outcomes remain poor, with an estimated 3-year survival rate of only 55%. Thus, there is a clear need ...

5. atsjournals.org atsjournals.org/doi/full/10.1513/AnnalsATS.202105-560OC

Physical Activity and Its Association with Traditional ... Higher levels of physical activity were associated with a greater 6-minute walk distance and better PAH-specific HRQoL, as defined by the E-10 ...

6. ahajournals.org ahajournals.org/doi/10.1161/circheartfailure.115.002130

Efficacy and Safety of Exercise Training in Chronic ... Conclusions— Exercise training in patients with pulmonary hypertension appears safe and is associated with a significant improvement in exercise capacity, ...