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

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to investigate the extent to which diet and exercise may improve PAH through the modulation of insulin sensitivity. The central hypothesis is that dysregulated glucose metabolism elicits a response in PAH patients that can be modified by exercise and diet, thereby leading to improvements in pulmonary vascular disease.

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.

Is nutrition and exercise safe for people with pulmonary arterial hypertension?

Exercise training has been shown to be safe for people with pulmonary arterial hypertension, as demonstrated in a large European study. However, there is no specific safety data available for dietary interventions in this condition. ^{1 2 3 4 5}

How does the Nutrition and Exercise treatment for pulmonary arterial hypertension differ from other treatments?

The Nutrition and Exercise treatment for pulmonary arterial hypertension is unique because it combines dietary adjustments with physical exercise, focusing on improving nutritional deficiencies and enhancing physical fitness, which are not typically addressed in standard pharmacological treatments. This approach aims to improve quality of life and exercise capacity by addressing both nutritional and physical aspects of the condition. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Nutrition and Exercise for Pulmonary Arterial Hypertension?

Research shows that exercise training can improve symptoms, exercise capacity, and quality of life in patients with pulmonary arterial hypertension. Additionally, good nutrition is important as malnutrition can worsen the prognosis for these patients. ^{3 9 10 11 12}

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 need more than 4 liters per minute of oxygen.

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

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 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]

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 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]

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]

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]

Citations

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

Impact of malnutrition on prognosis in patients with pulmonary arterial hypertension. [2023]

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

A Mobile Health Intervention to Increase Physical Activity in Pulmonary Arterial Hypertension. [2022]

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

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

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

Effect of aerobic exercise training on fatigue and physical activity in patients with pulmonary arterial hypertension. [2022]

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

Malnutrition in pulmonary arterial hypertension: a possible role for dietary intervention. [2023]

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

Rehabilitation program in adult congenital heart disease patients with pulmonary hypertension. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Standardized exercise training is feasible, safe, and effective in pulmonary arterial and chronic thromboembolic pulmonary hypertension: results from a large European multicentre randomized controlled trial. [2022]

9. United States 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). [2023]

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

Nutritional status in pulmonary arterial hypertension. [2023]

11. United States 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). [2022]

12. England pubmed.ncbi.nlm.nih.gov

Contrasting haemodynamic effects of exercise and saline infusion in older adults with pulmonary arterial hypertension. [2021]