Longitudinal Changes in Exercise Capacity in Children and Young Adults With Sickle Cell Anemia
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Purpose
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.
| Condition |
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Sickle Cell Anemia |
| Study Type: | Observational |
| 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 ]
| Estimated Enrollment: | 90 |
| 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) |
| Groups/Cohorts |
|---|
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Subjects with sickle cell anemia
60 subjects with sickle cell anemia will be enrolled on the study.
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30 healthy controls
30 controls without sickle cell anemia or sickle cell trait will be enrolled on the study.
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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 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.
Eligibility| Ages Eligible for Study: | 8 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Sickle cell anemia patients followed at Children's Memorial Hospital. Healthy controls without sickle cell anemia or sickle cell trait are recruited through flyers posted in Children's Memorial Hospital.
Inclusion Criteria:
- age 8 to 21 years old; AND
- Hb SS or S-β0 thalassemia disease, confirmed by hemoglobin analysis; AND
- Previously participated in ClinicalTrials.gov ID: NCT01527799
Exclusion Criteria:
- inability to perform maximal testing due to physical limitation (e.g. stroke or avascular necrosis); OR
- 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
Contacts and Locations| Contact: Stephanie A Pelligra, MPH | 773-880-3871 | spelligra@childrensmemorial.org |
| Contact: Brynnan L Gilgour, BA | 773-880-3732 | bgilgour@childrensmemorial.org |
| United States, Illinois | |
| Children's Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60614 | |
| Contact: Robert I Liem, MD MS 773-880-3977 rliem@childrensmemorial.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 |
More Information
No publications provided
| Responsible Party: | Ann & Robert H Lurie Children's Hospital of Chicago |
| ClinicalTrials.gov Identifier: | NCT01558076 History of Changes |
| Other Study ID Numbers: | 2011-14565, 1K23HL094376 |
| Study First Received: | March 13, 2012 |
| Last Updated: | March 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
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Sickle cell anemia exercise testing cardiopulmonary disease |
Additional relevant MeSH terms:
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Anemia Anemia, Sickle Cell Hematologic Diseases Anemia, Hemolytic, Congenital |
Anemia, Hemolytic Hemoglobinopathies Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 23, 2013