Exercise Capacity in Pediatric Sickle Cell Anemia
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Purpose
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 |
|---|
|
Sickle Cell Anemia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | The Physiologic Assessment of Exercise Capacity in Pediatric Sickle Cell Anemia |
- VO2 max on cardiopulmonary exercise test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Change in VCAM level in response to exercise testing [ Time Frame: Baseline (Pre-exercise) and Post-exercise ] [ Designated as safety issue: No ]
- Skin fold measurements to detemine percent body fat [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- All patient reported pain episodes [ Time Frame: Every 2 months up to 2 years after baseline ] [ Designated as safety issue: No ]
- Change in secondary biomarkers in response to exercise test [ Time Frame: Baseline (Pre-exercise) and Post-exercise ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Plasma is collected and stored to be analyzed
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2009 |
| Groups/Cohorts |
|---|
| Subjects with Sickle Cell Anemia |
| Healthy controls |
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.
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 are recruited through flyers posted in Children's Memorial Hospital.
Inclusion Criteria:
- age 10 to 21 years old; AND
- Hb SS or S-β0 thalassemia disease, confirmed by hemoglobin analysis
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: | NCT01527799 History of Changes |
| Other Study ID Numbers: | 2009-13659, 1K23HL094376 |
| Study First Received: | January 31, 2012 |
| Last Updated: | February 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
|
Sickle cell anemia Exercise testing Cardiopulmonary disease |
Additional relevant MeSH terms:
|
Anemia Anemia, Sickle Cell Hematologic Diseases Anemia, Hemolytic, Congenital |
Anemia, Hemolytic Hemoglobinopathies Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 23, 2013