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Home Rehabilitation Improves Cardiac Effort in Pulmonary Arterial Hypertension
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 Start (Actual) 1 July 2024
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 50
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Rochester, New York, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 21 June 2024
  • First Submitted that Met QC Criteria 21 June 2024
  • First Posted 27 June 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 June 2024
  • Last Update Posted 27 June 2024
  • Last Verified June 2024