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

March 13, 2012
March 16, 2012
January 2012
December 2014   (final data collection date for primary outcome measure)
VO2 max on cardiopulmonary exercise test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01558076 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Longitudinal Changes in Exercise Capacity in Children and Young Adults With Sickle Cell Anemia
Longitudinal Changes in Exercise Capacity in Children and Young Adults With Sickle Cell Anemia

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
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.

Sickle Cell Anemia
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
8 Years to 21 Years
Yes
Contact: Stephanie A Pelligra, MPH 773-880-3871 spelligra@childrensmemorial.org
Contact: Brynnan L Gilgour, BA 773-880-3732 bgilgour@childrensmemorial.org
United States
 
NCT01558076
2011-14565, 1K23HL094376
Yes
Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Robert I Liem, MD MS Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP