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

Pulmonary Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05521113
• Other study ID #: 22-000414
• Status: Completed
• Start date: September 6, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Behavioral:
• Home Rehabilitation Monitoring System
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.
• Health coaching calls
12 telephone-based health coaching calls over a 12-week period

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Number of adverse events attributed to home-based pulmonary rehabilitation	12 weeks
Secondary	Change in EmPHasis-10 Quality of Life Survey	Measured using the EmPHasis-10 to determine how pulmonary hypertension affect subject's life. 10-item self-reported questionnaire, total score 0-50 with higher scores indicating worse outcomes or quality of life.	Baseline, 3 months
Secondary	Change in PAH-SYMPACT domain scores Quality of Life	Measured using the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire to assess pulmonary arterial hypertension symptoms over the past 24 hours and 7 days. 23-item self-reported questionnaire, total score 0-89 with higher scores indicating worse outcomes or quality of life.	Baseline, 3 months
Secondary	Change in self-management abilities	Measured by the Self-Management Ability Scale (SMAS-30) to determine self-management abilities. 30-item self-reported questionnaire, average overall scores 5-30 with higher scores indicating higher self-management abilities.	Baseline, 3 months
Secondary	Change in daily physical activity	Number of daily steps captured by the Home Rehabilitation Monitoring System	Baseline, 3 months
Secondary	Change in exercise capacity	Measured by 6-minute walk exercise captured by the Home Rehabilitation Monitoring System	Baseline, 3 months