Longitudinal Changes in Exercise Capacity in Children and Young Adults With Sickle Cell Anemia
The purpose of this study is to use comprehensive exercise testing to examine longitudinal changes in exercise capacity over a 2 year period in children and young adults with sickle cell anemia.
Sickle Cell Anemia
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Longitudinal Changes in Exercise Capacity in Children and Young Adults With Sickle Cell Anemia|
- VO2 max on cardiopulmonary exercise test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Quality of life questionnaires [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Echocardiogram [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Dual Energy X-ray Absorbtiometry [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Pulmonary Function Test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Subjects with sickle cell anemia
60 subjects with sickle cell anemia will be enrolled on the study.
30 healthy controls
30 controls without sickle cell anemia or sickle cell trait will be enrolled on the study.
Although the burden of sickle cell anemia (SCA) on affected individuals is significant, few studies have examined the influence of having SCA on such measures of physical function as exercise capacity. Moreover, the physiologic basis of poor physical functioning in children with SCA is unknown and has not been studied extensively. The purpose of this proposal is to use cardiopulmonary exercise testing (CPET) to gain a comprehensive understanding of longitudinal changes in exercise capacity, and the effect of poor exercise capacity on quality of life in children and young adults with SCA. The specific aims of this project are to: 1) Measure peak oxygen consumption (VO2), the reference standard for exercise capacity, in children and young adults with SCA classified by primary pathophysiologic contributor to their decreased exercise capacity, and 2) compare results of this exercise test with the results of previously completed exercise tests to determine longitudinal changes in exercise capacity. These aims will be performed in 60 subjects with SCA and 30 matched controls who participated in a previous study, IRB# 2009-13659; "The Physiologic Assessment of Exercise Capacity in Pediatric Sickle Cell Anemia". In a secondary analysis, we will also study the participants quality of life using a set of validated questionnaires. This study is essential because it will address several areas of exercise capacity, including the longterm effects of physiologic contributors to exercise limitation, that remain fundamental knowledge gaps in SCA.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558076
|Contact: Stephanie A Pelligra, MPHfirstname.lastname@example.org|
|Contact: Brynnan L Gilgour, BAemail@example.com|
|United States, Illinois|
|Children's Memorial Hospital||Recruiting|
|Chicago, Illinois, United States, 60614|
|Contact: Robert I Liem, MD MS 773-880-3977 firstname.lastname@example.org|
|Principal Investigator: Robert I Liem, MD MS|
|Sub-Investigator: Alexis A Thompson, MD MPH|
|Sub-Investigator: Adrienne Prestridge, MD|
|Principal Investigator:||Robert I Liem, MD MS||Ann & Robert H Lurie Children's Hospital of Chicago|