Home Rehabilitation Improves Cardiac Effort in Pulmonary Arterial Hypertension

NCT06477640 | Recruiting

• 1 other identifier: STUDY00009399
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension PAH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean change in six minutes walk distance

  baseline to 3 months

Study Arms (2)

Exercise Intervention Group

EXPERIMENTAL

Behavioral: Exercise

Standard of Care

PLACEBO COMPARATOR

Behavioral: Standard of Care

Interventions

Exercise BEHAVIORAL

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.

Exercise Intervention Group

Standard of Care BEHAVIORAL

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".

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• United Therapeutics: collaborator
• Mayo Clinic: collaborator
• University of Vermont Medical Center: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Interventions

Exercise; Standard of Care

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Daniel Lachant, DO

CONTACT

585-273-4608; daniel_lachant@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 27, 2024
• Study Start: July 29, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)