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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Arterial Hypertension PAH
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Standard of Care

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Lachant, DO; Phone Number: 585-273-4608; Email: daniel_lachant@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester Medical Center
      • Contact: Daniel Lachant, DO; Phone Number: 585-273-4608; Email: daniel_lachant@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Standard of Care	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".
Experimental: Exercise Intervention Group	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in cardiac effort	Cardiac effort is the number of heartbeats used during the a six minute walk test divided by walk distance	baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in six minutes walk distance	The amount of distance walked in six minutes	baseline to 3 months

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Mayo Clinic; United Therapeutics; University of Vermont Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Health Services Administration; Health Care Quality, Access, and Evaluation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality of Health Care; Quality Indicators, Health Care; Exercise; Standard of Care
• Other Study ID Numbers: STUDY00009399

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No