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Exercise Capacity in Pediatric Sickle Cell Anemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Ann & Robert H Lurie Children's Hospital of Chicago.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01527799
First received: January 31, 2012
Last updated: February 6, 2012
Last verified: January 2012
  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

Resource links provided by NLM:


Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527799

Contacts
Contact: Stephanie A Pelligra, MPH 773-880-3871 Spelligra@childrensmemorial.org
Contact: Brynnan L Gilgour, BA 773-880-3732 Bgilgour@childrensmemorial.org

Locations
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         
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
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 April 20, 2014