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Clinical Trials/NCT06477640
NCT06477640Active, not recruitingNot Applicable

Home Rehabilitation Improves Cardiac Effort in Pulmonary Arterial Hypertension

University of Rochester1 site in 1 country55 target enrollmentStarted: July 29, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
55
Locations
1
Primary Endpoint
Mean change in cardiac effort
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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-
  • •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

Arms & Interventions

Standard of Care

Placebo Comparator

Intervention: Standard of Care (Behavioral)

Exercise Intervention Group

Experimental

Intervention: Exercise (Behavioral)

Outcomes

Primary Outcomes

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

  • Mean change in six minutes walk distance(baseline to 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Daniel Lachant

Assistant Professor

University of Rochester

Study Sites (1)

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