Clinical Trial: Exercise Capacity in Pediatric Sickle Cell Anemia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: The Physiologic Assessment of Exercise Capacity in Pediatric Sickle Cell Anemia

Brief Summary: The purpose of this study is to use comprehensive exercise testing to examine causes of exercise limitation 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 exercise capacity, as a measure of physical function, 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) Examine the acute inflammatory response, measured by an increase in soluble vascular cell adhesion molecule (sVCAM) activity, in subjects undergoing CPET. These aims will be performed in 60 subjects with SCA and 30 matched controls without SCA. In a secondary analysis, we will also study the impact of baseline exercise capacity and the inflammatory response to exercise on short and long-term disease related morbidity. This study is essential because it will address several areas of exercise capacity, including the 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:

  • VO2 max on cardiopulmonary exercise test [ Time Frame: Baseline ]
  • Change in VCAM level in response to exercise testing [ Time Frame: Baseline (Pre-exercise) and Post-exercise ]


Current Secondary Outcome:

  • Skin fold measurements to detemine percent body fat [ Time Frame: Baseline ]
  • All patient reported pain episodes [ Time Frame: Every 2 months up to 2 years after baseline ]
  • Change in secondary biomarkers in response to exercise test [ Time Frame: Baseline (Pre-exercise) and Post-exercise ]
  • Change in VCAM level in response to exercise testing [ Time Frame: Baseline (pre-exercise) and Post-exercise ]


Original Secondary Outcome:

  • Skin fold measurements to detemine percent body fat [ Time Frame: Baseline ]
  • All patient reported pain episodes [ Time Frame: Every 2 months up to 2 years after baseline ]
  • Change in secondary biomarkers in response to exercise test [ Time Frame: Baseline (Pre-exercise) and Post-exercise ]


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

Dates:
Date Received: January 31, 2012
Date Started: June 2009
Date Completion:
Last Updated: February 3, 2016
Last Verified: February 2016