Home Rehabilitation Improves Cardiac Effort in Pulmonary Arterial Hypertension

NCT ID: NCT06477640

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-29
• Study Completion Date: 2026-12-31

Brief Summary

The purpose of this study is to evaluate whether a home rehabilitation program for patients diagnosed with Pulmonary Arterial Hypertension (PAH) will decrease Cardiac Effort (number of heart beats used during 6-minute walk test/walk distance) and improve quality of life. Ultimately, this information could help improve the management of patients with PAH.

Conditions

Pulmonary Arterial Hypertension PAH

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Exercise Intervention Group

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

The intervention group will receive daily activity messages sent through SMS text message or email.The messages will provide daily exercises with heart rate guidance.

Standard of Care

Group Type: PLACEBO_COMPARATOR

Standard of Care

Intervention Type: BEHAVIORAL

The control group will receive daily non-descript messages to help with blinding and to eliminate the confounding variable of daily contact. The messages will not include activity tasks and will include phrases such as "I hope you have a good day".

Interventions

Exercise

The intervention group will receive daily activity messages sent through SMS text message or email.The messages will provide daily exercises with heart rate guidance.

Intervention Type: BEHAVIORAL

Standard of Care

The control group will receive daily non-descript messages to help with blinding and to eliminate the confounding variable of daily contact. The messages will not include activity tasks and will include phrases such as "I hope you have a good day".

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United Therapeutics

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

University of Vermont Medical Center

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Daniel Lachant

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rochester Medical Center

Rochester, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Daniel Lachant, DO

Role: CONTACT

daniel_lachant@urmc.rochester.edu

585-273-4608

Facility Contacts

Daniel Lachant, DO

Role: primary

daniel_lachant@urmc.rochester.edu

585-273-4608

Other Identifiers

STUDY00009399

Identifier Type: -

Identifier Source: org_study_id