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Active, Not Recruiting

NCT Number: NCT04101630

Activity Monitoring in Pulmonary Hypertension

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Activity Monitoring

Behavioral

Monitoring with FitBit

Primary outcomes

  1. Activity Monitoring

    Time frame: Baseline

    Participants will wear an accelerometer to record activity level

  2. Activity Monitoring

    Time frame: 1 year

    Participants will wear an accelerometer to record activity level

  3. Activity Monitoring

    Time frame: 2 year

    Participants will wear an accelerometer to record activity level

  4. Activity Monitoring

    Time frame: 3 year

    Participants will wear an accelerometer to record activity level

Secondary outcomes

  1. Six Minute Walk Distance (6MWD) Test

    Time frame: Baseline, 1 year, 2 year, 3 year

    Six Minute Walk Distance Test

  2. Intensity of Activity

    Time frame: Baseline, 1 year, 2 year, 3 year

    Intensity of activity is categorized as rest, light, moderate, and vigorous based on calculated metabolic equivalents.

  3. Quality of Life 36-Item Short Form Survey (SF-36)

    Time frame: Baseline, 1 year, 2 year, 3 year

    Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  4. emPHasis-10

    Time frame: Baseline, 1 year, 2 year, 3 year

    The emPHasis-10 is a pulmonary hypertension-specific questionnaire to assess health related quality of life. It covers breathlessness, fatigue and lack of energy, social restrictions, and concerns regarding effects on patient's significant others, such as family and friends. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicating worse quality of life.

  5. Minnesota Living with Heart Failure (MLHF)

    Time frame: Baseline, 1 year, 2 year, 3 year

    The MLHFQ is one of the most widely used health-related quality of life questionnaires for patients with heart failure. It provides scores for two dimensions, physical and emotional, and a total score. It is a reliable and valid patient-oriented measure of the adverse effects of heart failure on a patient's life. The score can range from 0-126 with 0 being minimal impact and 126 being high impact.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Sep 24, 2019
Registry last updated
Sep 26, 2025

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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