Activity Monitoring in Pulmonary Hypertension

Vanderbilt University Medical Center

Status: Active, not recruiting

Conditions: Pulmonary Hypertension

Treatments: Behavioral: Activity Monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT04101630

Physical Activity in PH

Details and patient eligibility

About

This is a prospective, longitudinal, observational study of free-living activity trackers and patient reported outcomes to test the hypothesis that daily activity will have stronger prognostic value than 6MWD in patients with pulmonary hypertension after 12 weeks.

Full description

A prospective, longitudinal, observational study of free-living activity tracking and patient-reported outcomes in patients with pulmonary hypertension. Participants will undergo activity monitoring for 12 weeks once a year for 4 years. Patient-reported outcomes will be collected including quality of life (emphasis-10, Minnesota Living with Heart Failure (MLHF), and SF-36 surveys), medication changes, hospitalization, and death. This study aims to enroll 500 participants. The objectives of this study are to establish the clinical utility of daily activity tracking in patients with pulmonary hypertension and to identify clinical factors associated with reduced daily activity.

Enrollment: 230 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Enrolled in L-PVDOMICS or
• Any patient in the United States with pulmonary hypertension confirmed by hemodynamics and expert clinical diagnosis

Exclusion criteria

• Pregnancy
• Hospitalization within the prior 3 months
• Orthopedic limitations that preclude 6MWD testing

Trial design

230 participants in 2 patient groups

Participants with Pulmonary Hypertension

Description:

Participants will undergo activity monitoring for 12 weeks, at baseline and once a year for 3 years. Patient reported outcomes will be collected including Quality of Life questionnaires \[emphasis-10, Minnesota Living with Heart Failure (MLHF), and SF-36 surveys\], medication changes, hospitalization, and death.

Treatment:

Behavioral: Activity Monitoring

Healthy Volunteers

Description:

Participants will undergo activity monitoring for 12 weeks, at baseline and once a year for 3 years. Patient reported outcomes will be collected including Quality of Life questionnaires \[emphasis-10, Minnesota Living with Heart Failure (MLHF), and SF-36 surveys\], medication changes, hospitalization, and death.

Treatment:

Behavioral: Activity Monitoring