Actigraphy in Pediatric Pulmonary Hypertension

NCT02909608 | Completed

• 1 other identifier: 16-1422
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 2

Brief Summary

Physical activity is an important factor in understanding how diseases can affect a child. Decreases in physical activity are sometimes the first thing that happens before a child is diagnosed with a disease. When a child sees their doctor, that visit reflects a single point in time. It does not capture how a child feels during the days in between visits to their doctor. This study plans to use special monitors called actigraphs to collect information about physical activity in children with a type of disease called pulmonary hypertension. This study will measure how active these children are and compare their activity to clinical information and to actigraphy measurements in children without pulmonary hypertension.

Conditions

Pediatric Pulmonary Hypertension

Outcome Measures

Primary Outcomes (2)

• Investigate and define the utility of the measurement properties of actigraphy in children with PAH: Baseline

  Children will wear both actigraphy devices for 2 weeks at 2 different time points. The first time point is at Baseline when the child enters the study. The second time point is at Week 26, which is 26 weeks after the Baseline timepoint.

  Baseline

• Investigate and define the utility of the measurement properties of actigraphy in children with PAH: Week 26

  Children will wear both actigraphy devices for 2 weeks at 2 different time points. The first time point is at Baseline when the child enters the study. The second time point is at Week 26, which is 26 weeks after the Baseline timepoint.

  Week 26

Secondary Outcomes (1)

• Use statistical analysis to determine correlations of actigraphy with disease severity, progression, clinical worsening, and survival, based on data from this prospective clinical study.

  For 18 months

Study Arms (2)

Controls

Other: No interventions / observations only

Children With Pulmonary Hypertension

Other: No interventions / observations only

Interventions

No interventions / observations only OTHER

This is an observational study only

Also known as: There are no interventions as part of this study

Children With Pulmonary Hypertension; Controls

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

We will include children with pulmonary hypertension and children without pulmonary hypertension into this study. All enrolled children must be between the ages of 8-14 years at the time of enrollment.

You may qualify if:

• Ages 8-14 years at the time of consent
• Current diagnosis of pulmonary hypertension in WHO Diagnostic Group 1 as per established clinical criteria
• Ages 8-14 years at the time of consent
• Absence of significant cardiopulmonary disease as per medical history

You may not qualify if:

• Current disease severity of Panama functional class IIIb or IV
• Any bone, neuromuscular, or other pathology that may limit activity
• Use of any medications known to limit activity
• Active infection, or has any of the following:
• cardiovascular,
• liver,
• renal,
• hematologic,
• gastrointestinal,
• immunologic,
• endocrine,
• metabolic, or
• central nervous system
• disease or condition that, in the opinion of the Investigator, may adversely affect the safety of the subject or interfere with the interpretation of study assessments.
• Actively listed for transplantation

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (2)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Kleppinger C, Ivy D, Stockbridge N, Bates A, Handler S, Krishnan US, Mullen MP, Yung D, Hopper RK, Varghese NP, Fineman J, Austin ED, Avitabile CM, Freire G, Clark J, Sun H. Procedural Variation May Contribute to 6-Minute Walk Distance Variability in Real-World Pediatric Pulmonary Arterial Hypertension Study. AAPS J. 2025 Jun 27;27(5):114. doi: 10.1208/s12248-025-01098-7.

  PMID: 40579609 DERIVED

Study Officials

• Dunbar Ivy, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: September 21, 2016
• Study Start: October 7, 2016
• Primary Completion: March 31, 2020
• Study Completion: April 2, 2020
• Last Updated: June 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)