What side effects are associated with this type of intervention?

Common treatments for Pulmonary Arterial Hypertension (PAH) include PDE5 inhibitors like sildenafil and tadalafil, which can cause headaches, flushing, dyspepsia, and visual disturbances. Prostacyclin analogs such as epoprostenol and treprostinil may lead to side effects like jaw pain, nausea, vomiting, diarrhea, and flushing. Endothelin receptor antagonists like bosentan can cause liver enzyme elevations, anemia, and peripheral edema. These treatments aim to improve exercise capacity and hemodynamics but come with a range of potential side effects that should be monitored by healthcare providers.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Pulmonary Arterial Hypertension (PAH), including phosphodiesterase-5 inhibitors (PDE5Is) like sildenafil and tadalafil, which improve exercise capacity and hemodynamics. Other approved treatments include oral treprostinil and inhaled prostanoids like iloprost, often used in combination therapies to enhance functional outcomes. These medications align with the goals of home-based exercise programs and behavioral modifications aimed at improving exercise tolerance and physical activity in PAH patients.

What other types of research exist?

Promising alternatives to home-based exercise programs for PAH patients include: 1) Supervised outpatient rehabilitation programs, which have shown improvements in hemodynamics and right ventricular function. 2) Combined strength and endurance training, which enhances physical capacity. 3) Pharmacological interventions such as macitentan and sildenafil, which have been studied for their potential to improve exercise tolerance. 4) Innovative therapies like inhaled nitric oxide during exercise, which may offer additional benefits in managing PAH.

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Behavioral Intervention

Home-Based Exercise for Pulmonary Hypertension (PaRTAkE-PH Trial)

N/A

Waitlist Available

Led By Thomas Cascino, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Competent to give informed consent

Diagnosis of group 1 Pulmonary Atrial Hypertension (PAH) diagnosed during right heart catheterization (RHC) according to WHO criteria 28

Must not have

Moderate or severe obstructive lung disease forced expiratory volume/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 65% of predicted value after bronchodilator administration

Co-morbidities which limit physical activity to a severe degree (i.e., permanently wheelchair bound, musculoskeletal disorders, recent myocardial infarction, unstable arrhythmia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a home-based exercise program can help people with pulmonary arterial hypertension (PAH) improve their ability to exercise and be more active. The goal is to see if regular exercise at home can lead to better health for these patients. Exercise-based rehabilitation for patients with pulmonary arterial hypertension (PAH) is a new treatment option aimed at improving their functional capacity and quality of life.

Who is the study for?

This trial is for individuals with stable Pulmonary Arterial Hypertension (PAH) who've had consistent treatment for at least 3 months. They should be able to follow up at the University of Michigan Hospital Centers for a year, have internet access, and not exercise regularly already. Excluded are those severely limited in physical activity, with life expectancy under a year or severe lung disease.

What is being tested?

The study is examining whether a home-based exercise program can improve how far patients with PAH can walk and their overall physical activity compared to usual care without this program. Participants will either continue their normal routine or start the new exercise regimen.

What are the potential side effects?

Since this trial involves an exercise program rather than medication, side effects may include muscle soreness, fatigue, or breathlessness during activities. Serious risks might involve heart-related events due to increased physical exertion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand and can agree to the study's procedures and risks.

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I have been diagnosed with a specific type of high blood pressure in the lungs.

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My heart condition mildly to moderately affects my daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lung function tests show severe breathing obstruction.

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I have health conditions that severely limit my physical activity.

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My oxygen levels drop below 88% during a 6-minute walk test or below 80% due to a heart issue.

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I can walk less than 150 meters or more than 550 meters in six minutes.

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My lung capacity is less than 60% of what is expected.

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I do not speak English.

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I have recently completed, am currently in, or plan to enroll in a lung rehab program within 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of a home-based exercise training as measured by change in six-minute walk distance

Secondary study objectives

Change in physical activity as measured by daily activity captured using the pedometer step count

Efficacy of a home-based exercise training as measured by change in World Health Organization (WHO) functional class

Efficacy of a home-based exercise training as measured by change in survey score International Physical Activity Questionnaire Short Form (IPAQ-SF)

+3 more

Other study objectives

Change in number of low risk criteria

Frequency of need for escalation of pulmonary hypertension therapy

Frequency worsening WHO functional class

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Home-based exercise programExperimental Treatment1 Intervention

Home-based individualized exercise program based on heart rate reserve (HRR).

Group II: Usual CareActive Control1 Intervention

Usual care administered at the Pulmonary Arterial Hypertension (PAH) clinic at the University of Michigan.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Home-based exercise program

2021

Completed Phase 2

~210

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Pulmonary Arterial Hypertension (PAH) include Phosphodiesterase-5 inhibitors (PDE5Is) like sildenafil and tadalafil, which work by increasing cyclic GMP levels leading to vasodilation and reduced pulmonary vascular resistance. Endothelin Receptor Antagonists (ERAs) such as bosentan block endothelin-1, a potent vasoconstrictor, thereby reducing blood vessel constriction and lowering blood pressure in the lungs. Prostacyclin Analogues like epoprostenol mimic the effects of prostacyclin, promoting vasodilation and inhibiting platelet aggregation. These mechanisms are crucial for PAH patients as they help improve hemodynamics, exercise capacity, and overall quality of life. In the context of a home-based exercise program, these treatments can enhance the benefits of physical activity by improving the cardiovascular response and reducing symptoms, thereby enabling patients to engage more effectively in exercise regimens.