Clinical Trial: Longitudinal Changes in Exercise Capacity in Children and Young Adults With Sickle Cell Anemia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Longitudinal Changes in Exercise Capacity in Children and Young Adults With Sickle Cell Anemia

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Current Primary Outcome: VO2 max on cardiopulmonary exercise test [ Time Frame: Baseline ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life questionnaires [ Time Frame: Baseline ]
  • Echocardiogram [ Time Frame: Baseline ]
  • Dual Energy X-ray Absorbtiometry [ Time Frame: Baseline ]
  • Pulmonary Function Test [ Time Frame: Baseline ]


Original Secondary Outcome: Same as current

Information By: Ann & Robert H Lurie Children's Hospital of Chicago

Dates:
Date Received: March 13, 2012
Date Started: January 2012
Date Completion: December 2016
Last Updated: September 21, 2015
Last Verified: September 2015