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OpenTrials
Active, Not Recruiting

NCT Number: NCT06477640

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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".

Primary outcomes

  1. Mean change in cardiac effort

    Time frame: baseline to 3 months

    Cardiac effort is the number of heartbeats used during the a six minute walk test divided by walk distance

Secondary outcomes

  1. Mean change in six minutes walk distance

    Time frame: baseline to 3 months

    The amount of distance walked in six minutes

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Mayo Clinic
  • United Therapeutics
  • University of Vermont Medical Center

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2024
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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