Sickle Cell Anemia | Longitudinal Changes in Exercise Capacity in Children and Young Adults With Sickle Cell Anemia
Sickle Cell Anemia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Sickle Cell Anemia
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Subjects with sickle cell anemia60 subjects with sickle cell anemia will be enrolled on the study.
30 healthy controls30 controls without sickle cell anemia or sickle cell trait will be enrolled on the study.
Start Date: January 2012
Completed Date: December 2016
Primary Outcome: VO2 max on cardiopulmonary exercise test
Secondary Outcome: Quality of life questionnaires
Study sponsors, principal investigator, and references
Principal Investigator: Robert I Liem, MD MS
Collaborator: National Heart, Lung, and Blood Institute (NHLBI)