Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension
Feasibility of Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension
1 other identifier
observational
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2022
CompletedFirst Posted
Study publicly available on registry
August 30, 2022
CompletedStudy Start
First participant enrolled
September 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedApril 22, 2024
April 1, 2024
10 months
August 26, 2022
April 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Events
Number of adverse events attributed to home-based pulmonary rehabilitation
12 weeks
Secondary Outcomes (5)
Change in EmPHasis-10 Quality of Life Survey
Baseline, 3 months
Change in PAH-SYMPACT domain scores Quality of Life
Baseline, 3 months
Change in self-management abilities
Baseline, 3 months
Change in daily physical activity
Baseline, 3 months
Change in exercise capacity
Baseline, 3 months
Study Arms (1)
Home Rehabilitation Monitoring System
Subjects will complete a home pulmonary rehabilitation program while using a home rehabilitation monitoring system and completing health coaching calls.
Interventions
The system consists of a small activity monitor worn on the wrist and a pulse oximeter worn on the finger while exercising. Simple exercises will be completed daily and the monitors will send information to a rehabilitation coach during a 12-week period.
12 telephone-based health coaching calls over a 12-week period
Eligibility Criteria
Subjects identified with the medical diagnoses of Pulmonary Arterial Hypertension (PAH) from the Mayo Clinic in Rochester, MN PH clinic.
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hilary DuBrock, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 26, 2022
First Posted
August 30, 2022
Study Start
September 6, 2022
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
April 22, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share