Home rehabilitation program for patients with pulmonary arterial hypertension

Home Rehabilitation Improves Cardiac Effort in Pulmonary Arterial Hypertension

This study tests if a home rehabilitation program can help people with pulmonary arterial hypertension feel better and make it easier for them to exercise.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Rochester (Academic / other)
• Locations: 1 site (Rochester, New York)
• Trial ID: NCT06477640 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a home rehabilitation program designed for patients diagnosed with Pulmonary Arterial Hypertension (PAH). The program aims to reduce cardiac effort, measured by the number of heartbeats during a 6-minute walk test, while also enhancing the overall quality of life for participants. Patients will engage in exercise alongside standard care, with their progress monitored over a 12-week period. The study is conducted at the University of Rochester Medical Center, ensuring a controlled environment for patient safety and data collection.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with confirmed pulmonary hypertension on stable medication for at least 30 days.

Not a fit: Patients experiencing ongoing improvement or clinical worsening at enrollment may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve the management and quality of life for patients with pulmonary arterial hypertension.

How similar studies have performed: Other studies have shown positive outcomes with rehabilitation programs for similar conditions, suggesting this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* Follows at University of Rochester Medical Center Pulmonary Hypertension Clinic.
* Adult patients (\>18 years old) with right heart catheterization confirmed pulmonary hypertension (PAH) on stable vasodilator dosing for at least 30 days. No planned titrations will occur during the 12-week study. If during the study, the treating physician feels it is necessary for safety reasons to adjust dosing, the subject will remain in their assigned group.
* Access to a smart phone or email to receive daily messages. If patients do not have access to either, we will offer a smartphone with cellular service for use during the study to receive daily messages.
* Clinically stable by the investigator (i.e., we will not enroll patients who endorse ongoing improvement or clinical worsening at enrollment).
* The treating investigator (Dr. Lachant or Dr. White) will review the clinical data of an eligible patient and establish them as safe to participate prior to approaching the patient for enrollment (i.e. not in decompensated heart failure or with recurrent pre-syncopal episodes prior to enrollment).

Exclusion Criteria:

* Pregnancy.
* Pulmonary Hypertension Groups 2-5.
* Resting tachycardia \>120 beats/m during screening.
* Inability to walk.
* WHO Functional Class IV
* Lack of access to email or text messaging.
* Inability to follow daily instructions. including the two home 6-minute walk tests during the initial monitoring period. This is to show compliance with the protocol.
* Participating in a self-reported rehabilitation or exercise program.
* Oxygen therapy of more than 6 L/min at rest.
* Principal Investigator discretion

Where this trial is running

Rochester, New York

• University of Rochester Medical Center — Rochester, New York, United States (Recruiting)

Study contacts

• Study coordinator: Daniel Lachant, DO

Conditions Pulmonary Arterial Hypertension PAH