RECRUITING

Home Rehabilitation Improves Cardiac Effort in Pulmonary Arterial Hypertension

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Home Rehabilitation Improves Cardiac Effort in Pulmonary Arterial Hypertension

Quick Facts

Study Start:2024-07-29

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06477640

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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

Inclusion Criteria

Exclusion 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).

* 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

Contacts and Locations

Study Contact

Daniel Lachant, DO

CONTACT

585-273-4608

daniel_lachant@urmc.rochester.edu

Study Locations (Sites)

University of Rochester Medical Center

Rochester, New York, 14642

United States

Collaborators and Investigators

Sponsor: University of Rochester

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

Study Start Date2024-07-29

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-07-29

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Pulmonary Arterial Hypertension PAH