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

NCT01558076 | Completed DMC

• 2 other identifiers: 2011-145651K23HL094376
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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)

• Quality of life questionnaires

  Baseline

• Echocardiogram

  Baseline

• Dual Energy X-ray Absorbtiometry

  Baseline

• Pulmonary Function Test

  Baseline

Study Arms (2)

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.

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 or sickle cell trait are recruited through flyers posted in Children's Memorial Hospital.

You may qualify if:

• age 8 to 21 years old; AND
• Hb SS or S-β0 thalassemia disease, confirmed by hemoglobin analysis; AND
• Previously participated in ClinicalTrials.gov ID: NCT01527799

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

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: Professor of Pediatrics, Attending Physician - Hematology-Oncology

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 20, 2012
• Study Start: January 1, 2012
• Primary Completion: April 11, 2017
• Study Completion: April 11, 2017
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

US (1)