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Completed

NCT Number: NCT05521113

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

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Home Rehabilitation Monitoring System

Behavioral

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

Behavioral

12 telephone-based health coaching calls over a 12-week period

Primary outcomes

  1. Adverse Events

    Time frame: 12 weeks

    Number of adverse events attributed to home-based pulmonary rehabilitation

Secondary outcomes

  1. Change in EmPHasis-10 Quality of Life Survey

    Time frame: Baseline, 3 months

    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.

  2. Change in PAH-SYMPACT domain scores Quality of Life

    Time frame: Baseline, 3 months

    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.

  3. Change in self-management abilities

    Time frame: Baseline, 3 months

    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.

  4. Change in daily physical activity

    Time frame: Baseline, 3 months

    Number of daily steps captured by the Home Rehabilitation Monitoring System

  5. Change in exercise capacity

    Time frame: Baseline, 3 months

    Measured by 6-minute walk exercise captured by the Home Rehabilitation Monitoring System

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2022
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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