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Home Rehabilitation Improves Cardiac Effort in Pulmonary Arterial Hypertension

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University of Rochester

Status

Enrolling

Conditions

Pulmonary Arterial Hypertension PAH

Treatments

Behavioral: Exercise
Behavioral: Standard of Care

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06477640
STUDY00009399

Details and patient eligibility

About

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.

Enrollment

55 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

55 participants in 2 patient groups, including a placebo group

Exercise Intervention Group
Experimental group
Treatment:
Behavioral: Exercise
Standard of Care
Placebo Comparator group
Treatment:
Behavioral: Standard of Care

Trial contacts and locations

1

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Central trial contact

Daniel Lachant, DO

Data sourced from clinicaltrials.gov

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