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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Ann & Robert H Lurie Children's Hospital of Chicago.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01558076
First Posted: March 20, 2012
Last Update Posted: September 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Ann & Robert H Lurie Children's Hospital of Chicago
March 13, 2012
March 20, 2012
September 23, 2015
January 2012
December 2016   (Final data collection date for primary outcome measure)
VO2 max on cardiopulmonary exercise test [ Time Frame: Baseline ]
Same as current
Complete list of historical versions of study NCT01558076 on ClinicalTrials.gov Archive Site
  • Quality of life questionnaires [ Time Frame: Baseline ]
  • Echocardiogram [ Time Frame: Baseline ]
  • Dual Energy X-ray Absorbtiometry [ Time Frame: Baseline ]
  • Pulmonary Function Test [ Time Frame: Baseline ]
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.
 
Unknown status
90
December 2016
December 2016   (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
Sexes Eligible for Study: All
8 Years to 21 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01558076
2011-14565
1K23HL094376 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
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
September 2015