Home Rehabilitation Improves Cardiac Effort in Pulmonary Arterial Hypertension

Not Applicable

Recruiting

• Conditions: Pulmonary Arterial Hypertension PAH
• Interventions: Behavioral: Exercise; Behavioral: Standard of Care

• Registration Number: NCT06477640
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-21
• Study First Posted: 2024-06-27
• Study Start: 2024-07-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Intervention Group	Exercise	-
Standard of Care	Standard of Care	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mean change in six minutes walk distance	baseline to 3 months	The amount of distance walked in six minutes

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States