Clinical Trials Directory

Trials / Completed

CompletedNCT02999438

Frailty in Children With Cardiac Disease

Frailty in Children With Cardiac Disease: A Pilot Study

Status
Completed
Phase
Study type
Observational
Enrollment
56 (actual)
Sponsor
Children's Mercy Hospital Kansas City · Academic / Other
Sex
All
Age
8 Years – 18 Years
Healthy volunteers
Accepted

Summary

Frailty is a complex biologic syndrome of diminished physiologic reserve that leads to decreased resistance to stressors and is associated with adverse health outcomes. The syndrome has been well studied in adults and is quantified by the Fried criteria, which are comprised of five components- slowness, weakness, self-reported exhaustion, shrinkage and diminished physical activity. The concept of frailty is novel in children. A study in young adult childhood cancer survivors demonstrated increased incidence of frailty in this population along with increased risk of morbidity and mortality. This suggests that frailty as a phenotype has relevance outside of the geriatric age group. Pediatric patients with single ventricle physiology, heart failure and pulmonary artery hypertension- all represent populations with significantly increased risk of mortality, morbidity and decreased quality of life. Currently, such patients are monitored outpatient by serial echocardiograms and blood work that only gives information about end organ damage. But there is no validated tool available to measure global infirmity in such children. Better understanding of the relevance and applicability of frailty in pediatrics may allow for identification of the most vulnerable pediatric cardiac patients and be of value in optimizing their clinical management and improving health outcomes.

Conditions

Interventions

TypeNameDescription
DEVICEActigraph to check activity levels at home

Timeline

Start date
2016-11-01
Primary completion
2022-09-01
Completion
2022-10-01
First posted
2016-12-21
Last updated
2023-07-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02999438. Inclusion in this directory is not an endorsement.