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Exercise Capacity in Pediatric Sickle Cell Anemia

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ClinicalTrials.gov Identifier: NCT01527799
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : February 4, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert I. Liem, Ann & Robert H Lurie Children's Hospital of Chicago

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.

Condition or disease
Sickle Cell Anemia

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Physiologic Assessment of Exercise Capacity in Pediatric Sickle Cell Anemia
Study Start Date : June 2009
Primary Completion Date : July 2015
Study Completion Date : July 2015

Subjects with Sickle Cell Anemia
Subjects with Sickle Cell Anemia, 10-21 years of age
Healthy controls
Healthy controls, 10 to 21 years of age

Primary Outcome Measures :
  1. VO2 max on cardiopulmonary exercise test [ Time Frame: Baseline ]

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

Biospecimen Retention:   Samples Without DNA
Plasma is collected and stored to be analyzed

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Sickle cell anemia patients followed at Children's Memorial Hospital. Healthy controls without sickle cell anemia are recruited through flyers posted in Children's Memorial Hospital.

Inclusion Criteria:

  1. age 10 to 21 years old; AND
  2. Hb SS or S-β0 thalassemia disease, confirmed by hemoglobin analysis

Exclusion Criteria:

  1. inability to perform maximal testing due to physical limitation (e.g. stroke or avascular necrosis); OR
  2. history of exercise-induced syncope or arrhythmias. Subjects will wait at least 2 weeks following any vaso-occlusive pain episode and 12 weeks following any disease-related complication requiring transfusion support. Individuals on hydroxyurea will be eligible. A total of 30 controls without SCA or sickle cell trait will be matched for age, sex and race and recruited from the siblings, friends or relatives of subjects enrolled on this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527799

United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Robert I Liem, MD, MS Ann & Robert H Lurie Children's Hospital of Chicago

Responsible Party: Robert I. Liem, Attending Physician, Hematology, Oncology,Cell Transplantation, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT01527799     History of Changes
Other Study ID Numbers: 2009-13659
1K23HL094376 ( U.S. NIH Grant/Contract )
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016

Keywords provided by Robert I. Liem, Ann & Robert H Lurie Children's Hospital of Chicago:
Sickle cell anemia
Exercise testing
Cardiopulmonary disease

Additional relevant MeSH terms:
Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Genetic Diseases, Inborn