Longitudinal Changes in Exercise Capacity in Children and Young Adults With Sickle Cell Anemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01558076
First received: March 13, 2012
Last updated: March 16, 2012
Last verified: March 2012
  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
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

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 ]

Secondary Outcome Measures:
  • 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
Subjects with sickle cell anemia
60 subjects with sickle cell anemia will be enrolled on the study.
30 healthy controls
30 controls without sickle cell anemia or sickle cell trait will be enrolled on the study.

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
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558076

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: 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:
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 July 23, 2014