Exercise Capacity in Pediatric Sickle Cell Anemia

NCT01527799 | Completed DMC

• 2 other identifiers: 2009-136591K23HL094376
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sickle Cell Anemia

Keywords

Sickle cell anemia; Exercise testing; Cardiopulmonary disease

Outcome Measures

Primary Outcomes (1)

• VO2 max on cardiopulmonary exercise test

  Baseline

Secondary Outcomes (4)

• Skin fold measurements to detemine percent body fat

  Baseline

• All patient reported pain episodes

  Every 2 months up to 2 years after baseline

• Change in secondary biomarkers in response to exercise test

  Baseline (Pre-exercise) and Post-exercise

• Change in VCAM level in response to exercise testing

  Baseline (pre-exercise) and Post-exercise

Study Arms (2)

Subjects with Sickle Cell Anemia

Subjects with Sickle Cell Anemia, 10-21 years of age

Healthy controls

Healthy controls, 10 to 21 years of age

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• age 10 to 21 years old; AND
• Hb SS or S-β0 thalassemia disease, confirmed by hemoglobin analysis

You may not qualify if:

• inability to perform maximal testing due to physical limitation (e.g. stroke or avascular necrosis); OR
• 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

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma is collected and stored to be analyzed

MeSH Terms

Conditions

Anemia, Sickle Cell; Pulmonary Heart Disease

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Diseases; Cardiovascular Diseases

Study Officials

• Robert I Liem, MD, MS

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Hematology, Oncology,Cell Transplantation

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 7, 2012
• Study Start: June 1, 2009
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 4, 2016

Record last verified: 2016-02

Locations

US (1)