Observational Study of Actigraphy in Pediatric Pulmonary Arterial Hypertension

Completed

• Conditions: Hypertension;Pulmonary;Primary

• Registration Number: NCT04745000
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-09
• Study Start: 2021-02-11
• Primary Completion: 2022-04-14
• Study Completion: 2022-04-14
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of skin irritation adverse events: Visit 1	Over 14 Days, reported at Day 15 post baseline (Visit 1)
Number of Participants Meeting Compliance threshold for wearing actigraphy devices: Visit 2	Over 14 days, reported at about 6 months post-baseline (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.
Number of Participants Meeting Compliance threshold for wearing actigraphy devices: Visit 1	Over 14 Days, reported at Day 15 post baseline (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.
Number of skin irritation adverse events: Visit 2	Over 14 days, reported at about 6 months post-baseline (Visit 2)

Secondary Outcome Measures

Name	Time	Method
Heart rate: Visit 2	Over 14 days, reported at about 6 months post-baseline (Visit 2)	Measured via Fitbit.
Energy expenditure per day (kcal): Visit 1	Over 14 Days, reported at Day 15 post baseline (Visit 1)	Measured via Fitbit and ActiGraph wGT3x-BT.
Heart rate: Visit 1	Over 14 Days, reported at Day 15 post baseline (Visit 1)	Measured via Fitbit.
Steps per day: Visit 1	Over 14 Days, reported at Day 15 post baseline (Visit 1)	Measured via Fitbit and ActiGraph wGT3x-BT.
Steps per day: Visit 2	Over 14 days, reported at about 6 months post-baseline (Visit 2)	Measured via Fitbit and ActiGraph wGT3x-BT.
Miles per day: Visit 1	Over 14 Days, reported at Day 15 post baseline (Visit 1)	Measured via Fitbit.
Miles per day: Visit 2	Over 14 days, reported at about 6 months post-baseline (Visit 2)	Measured via Fitbit.
Energy expenditure per day (kcal): Visit 2	Over 14 days, reported at about 6 months post-baseline (Visit 2)	Measured via Fitbit and ActiGraph wGT3x-BT.
Active minutes per day: Visit 2	Over 14 days, reported at about 6 months post-baseline (Visit 2)	Measured via Fitbit.
Count of Activity Bouts: Visit 1	Over 14 Days, reported at Day 15 post baseline (Visit 1)	Count of Active bouts recorded and defined by the Actigraphy devices.
Activity Count: Visit 1	Over 14 Days, reported at Day 15 post baseline (Visit 1)	Count of Activity Events recorded and defined by the Actigraphy devices.
Activity Count: Visit 2	Over 14 days, reported at about 6 months post-baseline (Visit 2)	Count of Activity Events recorded and defined by the Actigraphy devices.
Resting oxygen saturation at Visit 2	About 6 months post baseline
Active minutes per day: Visit 1	Over 14 Days, reported at Day 15 post baseline (Visit 1)	Measured via Fitbit.
Count of Activity Bouts: Visit 2	Over 14 days, reported at about 6 months post-baseline (Visit 2)	Count of Active bouts recorded and defined by the Actigraphy devices.
Count of Sedentary Bouts: Visit 1	Over 14 Days, reported at Day 15 post baseline (Visit 1)	Count of Sedentary Bouts recorded and defined by the Actigraphy devices.
Physical Activity intensity: Visit 1	Over 14 days, reported at about 6 months post-baseline (Visit 2)	Number of minutes with "Mild", "Moderate", and "Vigorous" physical activity.
Number of PH Participants with Clinical Worsening (CW) Events	End of Study (Up to 12 months post baseline)
Natriuretic Peptide Tests - BNP	End of Study (Up to 12 months post baseline)	Brain natriuretic peptide (BNP): a heart failure marker
Count of Sedentary Bouts: Visit 2	Over 14 days, reported at about 6 months post-baseline (Visit 2)	Count of Sedentary Bouts recorded and defined by the Actigraphy devices.
Natriuretic Peptide Tests - NT-proBNP)	End of Study (Up to 12 months post baseline)	N-terminal pro b-type natriuretic peptide (NT-proBNP): a heart failure marker
Resting oxygen saturation at Baseline	Baseline
Number of PH Participants with Genetic Mutations or Positive Genetic tests	End of Study (Up to 12 months post baseline)	Count of PH participants with an observed positive genetic test or genetic mutation.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States