Home Rehabilitation Improves Cardiac Effort in Pulmonary Arterial Hypertension

University of Rochester1 site in 1 country55 target enrollmentJuly 29, 2024

ConditionsPulmonary Arterial Hypertension PAH

Overview

Phase: N/A
Intervention: Not specified
Conditions: Pulmonary Arterial Hypertension PAH
Sponsor: University of Rochester
Enrollment: 55
Locations: 1
Primary Endpoint: Mean change in cardiac effort
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 29, 2024

End Date

December 31, 2026

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Rochester

Responsible Party

Principal Investigator

Daniel Lachant

Assistant Professor

University of Rochester

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-
•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