View Clinical Trial (Medical Research Study)
Longitudinal Changes in Exercise Capacity in Children and Young Adults With Sickle Cell Anemia
| City: |
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Chicago |
| State: |
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Illinois |
| Zip Code: |
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60614 |
| Conditions: |
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Sickle Cell Anemia |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
1. age 8 to 21 years old; AND
2. Hb SS or S-β0 thalassemia disease, confirmed by hemoglobin analysis; AND
3. Previously participated in ClinicalTrials.gov ID: NCT01527799
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
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| NCT ID: |
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NCT01558076 |
| Primary Contact: |
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Principal Investigator
Robert I Liem, MD MS
Children's Memorial Hospital
Stephanie A Pelligra, MPH
Phone: 773-880-3871
Email: spelligra@childrensmemorial.org
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| Backup Contact: |
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Email: bgilgour@childrensmemorial.org
Brynnan L Gilgour, BA
Phone: 773-880-3732
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| Location Contact: |
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Chicago, Illinois 60614
United States
Robert I Liem, MD MS
Phone: 773-880-3977
Email: rliem@childrensmemorial.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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