This study plans to learn more about activity levels in children with pulmonary hypertension. Pulmonary hypertension is a condition where the pressure in the lungs is higher than normal. This can affect the person's heart. The purpose of this study is to see if measuring activity in children with pulmonary hypertension and comparing it to activity in children without pulmonary hypertension can give their doctor helpful information on how they are feeling and how their treatment is working.
Study Type
OBSERVATIONAL
Enrollment
43
Children's Hospital Colorado
Aurora, Colorado, United States
Number of Participants Meeting Compliance threshold for wearing actigraphy devices: Visit 1
Actigraphy device wear compliance threshold is a minimum of 4 hours per day, and 8 compliant days out of 14 days of wear time.
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Number of Participants Meeting Compliance threshold for wearing actigraphy devices: Visit 2
Actigraphy device wear compliance threshold is a minimum of 4 hours per day, and 8 compliant days out of 14 days of wear time.
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Number of skin irritation adverse events: Visit 1
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Number of skin irritation adverse events: Visit 2
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Heart rate: Visit 1
Measured via Fitbit.
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Heart rate: Visit 2
Measured via Fitbit.
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Steps per day: Visit 1
Measured via Fitbit and ActiGraph wGT3x-BT.
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Steps per day: Visit 2
Measured via Fitbit and ActiGraph wGT3x-BT.
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Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Miles per day: Visit 1
Measured via Fitbit.
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Miles per day: Visit 2
Measured via Fitbit.
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Energy expenditure per day (kcal): Visit 1
Measured via Fitbit and ActiGraph wGT3x-BT.
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Energy expenditure per day (kcal): Visit 2
Measured via Fitbit and ActiGraph wGT3x-BT.
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Active minutes per day: Visit 1
Measured via Fitbit.
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Active minutes per day: Visit 2
Measured via Fitbit.
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Count of Activity Bouts: Visit 1
Count of Active bouts recorded and defined by the Actigraphy devices.
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Count of Activity Bouts: Visit 2
Count of Active bouts recorded and defined by the Actigraphy devices.
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Count of Sedentary Bouts: Visit 1
Count of Sedentary Bouts recorded and defined by the Actigraphy devices.
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Count of Sedentary Bouts: Visit 2
Count of Sedentary Bouts recorded and defined by the Actigraphy devices.
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Activity Count: Visit 1
Count of Activity Events recorded and defined by the Actigraphy devices.
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Activity Count: Visit 2
Count of Activity Events recorded and defined by the Actigraphy devices.
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Physical Activity intensity: Visit 1
Number of minutes with "Mild", "Moderate", and "Vigorous" physical activity.
Time frame: Over 14 Days, reported at Day 15 post baseline (Visit 1)
Physical Activity intensity: Visit 1
Number of minutes with "Mild", "Moderate", and "Vigorous" physical activity.
Time frame: Over 14 days, reported at about 6 months post-baseline (Visit 2)
Resting oxygen saturation at Baseline
Time frame: Baseline
Resting oxygen saturation at Visit 2
Time frame: About 6 months post baseline
Number of PH Participants with Clinical Worsening (CW) Events
Time frame: End of Study (Up to 12 months post baseline)
Number of PH Participants with Genetic Mutations or Positive Genetic tests
Count of PH participants with an observed positive genetic test or genetic mutation.
Time frame: End of Study (Up to 12 months post baseline)
Natriuretic Peptide Tests - BNP
Brain natriuretic peptide (BNP): a heart failure marker
Time frame: End of Study (Up to 12 months post baseline)
Natriuretic Peptide Tests - NT-proBNP)
N-terminal pro b-type natriuretic peptide (NT-proBNP): a heart failure marker
Time frame: End of Study (Up to 12 months post baseline)