Exercise Capacity in Pediatric Sickle Cell Anemia

Sickle Cell Anemia Clinical Trial

Official title:

The Physiologic Assessment of Exercise Capacity in Pediatric Sickle Cell Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527799
• Other study ID #: 2009-13659
• Secondary ID: 1K23HL094376
• Status: Completed
• Phase: N/A
• First received: January 31, 2012
• Last updated: February 3, 2016
• Start date: June 2009
• Est. completion date: July 2015

Study information

• Verified date: February 2016
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 21 Years

Eligibility

Inclusion Criteria:

1. age 10 to 21 years old; AND

2. Hb SS or S-ß0 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anemia
• Anemia, Sickle Cell
• Sickle Cell Anemia

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2 max on cardiopulmonary exercise test		Baseline	No
Secondary	Skin fold measurements to detemine percent body fat		Baseline	No
Secondary	All patient reported pain episodes		Every 2 months up to 2 years after baseline	No
Secondary	Change in secondary biomarkers in response to exercise test		Baseline (Pre-exercise) and Post-exercise	No
Secondary	Change in VCAM level in response to exercise testing		Baseline (pre-exercise) and Post-exercise	No