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Clinical Trials/NCT05521113
NCT05521113
Completed
N/A

Feasibility of Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension

Mayo Clinic1 site in 1 country14 target enrollmentSeptember 6, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pulmonary Arterial Hypertension
Sponsor
Mayo Clinic
Enrollment
14
Locations
1
Primary Endpoint
Adverse Events
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this study is to test new technology and health coaching aimed to help people with PAH become more physically active in their daily lives.

Registry
clinicaltrials.gov
Start Date
September 6, 2022
End Date
June 30, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hilary M. DuBrock, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of PAH, confirmed by right heart catheterization (mean pulmonary artery pressure of 20 mmHg or greater, pulmonary vascular resistance of 3.0 Woods units or greater, Pulmonary capillary wedge pressure of 15 mmHg or lower).
  • On PAH-specific therapy which is at stable dosing (i.e., not currently titrating therapy).
  • NYHA class II-III symptoms.
  • Able to complete a six-minute walk test.

Exclusion Criteria

  • Patients experiencing syncope or exertional syncope.
  • Patients not experiencing exertional dyspnea.
  • Inability to walk.
  • Patients currently in pulmonary rehab or having completed pulmonary rehab within three months (unlikely to improve).

Outcomes

Primary Outcomes

Adverse Events

Time Frame: 12 weeks

Number of adverse events attributed to home-based pulmonary rehabilitation

Secondary Outcomes

  • Change in EmPHasis-10 Quality of Life Survey(Baseline, 3 months)
  • Change in daily physical activity(Baseline, 3 months)
  • Change in exercise capacity(Baseline, 3 months)
  • Change in PAH-SYMPACT domain scores Quality of Life(Baseline, 3 months)
  • Change in self-management abilities(Baseline, 3 months)

Study Sites (1)

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