- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03653676
Sickle Cell Pro-Inflammatory Response to Interval Training Study (SPRINTS)
The Pro-Inflammatory Effects of Acute Exercise in Children With Sickle Cell Anemia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Robert Liem, MD
- Phone Number: 312-227-4842
- Email: rliem@luriechildrens.org
Study Contact Backup
- Name: Connie Casale, BS
- Phone Number: 312-227-4856
- Email: ccasale@luriechildrens.org
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Ann & Robert H. Lurie Children's Hospital of Chicago
-
Contact:
- Connie Casale
- Phone Number: 312-227-4856
- Email: ccasale@luriechildrens.org
-
Principal Investigator:
- Robert Liem, MD
-
Chicago, Illinois, United States, 60608
- Recruiting
- University of Illinois at Chicago
-
Sub-Investigator:
- Tracy Baynard, PhD
-
Contact:
- Garett Griffith
- Phone Number: 312-996-9594
- Email: gjgriff@uic.edu
-
Principal Investigator:
- Lewis Hsu, MD, PhD
-
-
New York
-
New York, New York, United States, 10032
- Recruiting
- Columbia University Medical Center
-
Contact:
- Juan Grateron
- Phone Number: 212-304-7806
- Email: jg3751@cumc.columbia.edu
-
Principal Investigator:
- Nancy Green, MD
-
Sub-Investigator:
- Robert Garofano, EdD, RCEP
-
-
Tennessee
-
Memphis, Tennessee, United States, 38105
- Recruiting
- St. Jude Children's Research Hospital
-
Contact:
- Kristen Woodward
- Phone Number: 901-595-5685
- Email: kristen.woodward@st.jude.org
-
Principal Investigator:
- Jane Hankins, MD
-
Sub-Investigator:
- Kirsten Ness, PT, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
This study will plan to enroll a total of 70 non-asthmatic subjects with SCA and 70 controls without SCA across all sites. Male or female, aged 10 years to 21 years old. Diagnosis of hemoglobin SS or S/Beta0 thalassemia confirmed by hemoglobin electrophoresis.
Children and young adults on hydroxyurea are eligible but must be at steady state at time of enrollment, defined as stable dosing for at least 2 months, without anticipated changes in dose during study participation.
Race and age-matched controls without SCA or sickle cell trait will be recruited among friends, relatives, siblings or individuals from similar communities to minimize confounding socio-demographic variables that may impact baseline fitness. Controls will be required to be 10 through 21 years of age.
Description
Inclusion Criteria:
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- Male or female, aged 10 years to 21 years old
- Diagnosis of hemoglobin SS or S/Beta0 thalassemia confirmed by hemoglobin electrophoresis
Exclusion Criteria:
- Inability to perform CPET due to physical limitation (e.g. severe hip osteonecrosis or stroke)
- Enrollment on chronic transfusion program
- History of exercise-induced arrhythmia or syncope
- Diagnosis of asthma, defined as physician diagnosis or use of daily asthma medications
- Known exercise-induced bronchoconstriction, defined as physician diagnosis by exercise challenge test
- History of any cardiac diagnosis precluding exercise testing, unless cleared by a cardiologist
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Subjects with SCA
Children and adolescents with SCA confirmed by hemoglobin analysis randomized to either moderate or vigorous intensity exercise test (CIIT)
|
The CIIT exercise test will consist of 8 bouts (2 minute each) of constant workload cycling with rest periods (1 minute each) in between each bout of exercise.
Subjects and controls will be randomized to either a moderate intensity or vigorous intensity, defined as 50% or 70% of the maximal workload achieved on the maximal cardiopulmonary exercise test (CPET).
|
Controls without SCA
Children and adolescents without SCA or sickle cell trait randomized to either moderate or vigorous intensity exercise test (CIIT)
|
The CIIT exercise test will consist of 8 bouts (2 minute each) of constant workload cycling with rest periods (1 minute each) in between each bout of exercise.
Subjects and controls will be randomized to either a moderate intensity or vigorous intensity, defined as 50% or 70% of the maximal workload achieved on the maximal cardiopulmonary exercise test (CPET).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biomarker- VCAM-1
Time Frame: Through study completion, approximately 2 years
|
Change in soluble vascular cell adhesion molecule VCAM-1 in ng/mL
|
Through study completion, approximately 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biomarker - ICAM-1
Time Frame: Through study completion, approximately 2 years
|
Change in intercellular adhesion molecule-1 in ng/mL
|
Through study completion, approximately 2 years
|
Biomarker - PECAM-1
Time Frame: Through study completion, approximately 2 years
|
Change in platelet endothelial cell adhesion molecule-1 in ng/mL
|
Through study completion, approximately 2 years
|
Biomarker - L-selectin
Time Frame: Through study completion, approximately 2 years
|
Change in L-selectin in ng/mL
|
Through study completion, approximately 2 years
|
Biomarker - E-selectin
Time Frame: Through study completion, approximately 2 years
|
Change in E-selectin in ng/mL
|
Through study completion, approximately 2 years
|
Biomarker - P-selectin
Time Frame: Through study completion, approximately 2 years
|
Change in P-selectin in ng/mL
|
Through study completion, approximately 2 years
|
Biomarker - IL-6
Time Frame: Through study completion, approximately 2 years
|
Change in interleukin-6 in pg/mL
|
Through study completion, approximately 2 years
|
Exercise spirometry
Time Frame: Through study completion, approximately 2 years
|
Forced expiratory volume in 1 second (FEV1 mesured in % of normal predicted value)
|
Through study completion, approximately 2 years
|
Near infrared spectroscopy (NIRS) - total oxygen saturation
Time Frame: Through study completion, approximately 2 years
|
Near infrared spectroscopy (NIRS) derived measurements (total oxygen saturation (StO2) in the pre-frontal cortex and vastus lateralis muscle) in %
|
Through study completion, approximately 2 years
|
Near infrared spectroscopy (NIRS) - oxygenated hemoglobin
Time Frame: Through study completion, approximately 2 years
|
Near infrared spectroscopy (NIRS) derived measurements (oxygenated hemoglobin in the pre-frontal cortex and vastus lateralis muscle) in %
|
Through study completion, approximately 2 years
|
Near infrared spectroscopy (NIRS) - deoxygenated hemoglobin
Time Frame: Through study completion, approximately 2 years
|
Near infrared spectroscopy (NIRS) derived measurements (deoxygenated hemoglobin in the pre-frontal cortex and vastus lateralis muscle) in %
|
Through study completion, approximately 2 years
|
Genomic studies
Time Frame: Through study completion, approximately 2 years
|
Gene and microRNA expression in mononuclear cells measured by fold change
|
Through study completion, approximately 2 years
|
Asthma risk screening - ISAAC questionnaire
Time Frame: Through study completion, approximately 2 years
|
International Study of Asthma and Allergies in Childhood (ISAAC) screening questionnaire for rhinitis and eczema based on yes/no responses and point system to determine severity of condition (e.g. for rhinitis, 0 to 3 points (most severe); for eczema, 0 to 4 points (most severe)).
|
Through study completion, approximately 2 years
|
Asthma risk screening - FeNO measurement
Time Frame: Through study completion, approximately 2 years
|
Exhaled nitric oxide (FeNO) in ppb)
|
Through study completion, approximately 2 years
|
Asthma risk screening - Urinary Leukotrienes
Time Frame: Through study completion, approximately 2 years
|
Urine leukotriene (LTE4) in pg/mg)
|
Through study completion, approximately 2 years
|
Eucapnic voluntary hyperventilation (EVH) spirometry
Time Frame: Through study completion, approximately 2 years
|
Forced expiratory volume in 1 second (FEV1 in % of normal predicted value) will be taken after EVH at 5, 10, 15, and 30 minutes to assess exercise induced bronchoconstriction in a subset of participants.
|
Through study completion, approximately 2 years
|
Adverse events
Time Frame: Through study completion, approximately 2 years
|
Safety outcomes including number of cardiopulmonary complications, vaso-occlusive pain or other adverse events related to exercise and EVH reported as incidence (number and %).
|
Through study completion, approximately 2 years
|
Patient reported physical functioning - fatigue
Time Frame: Through study completion, approximately 2 years
|
NIH PROMIS questionnaire for fatigue using appropriate raw summed and T scores with higher scores indicating worse fatigue (pediatric - raw 0 to 40, T score 30.3 to 84; parent proxy - raw 0 to 40, T score 34 to 85; adult - raw 8 to 40, T score 33.1 to 77.8)
|
Through study completion, approximately 2 years
|
Patient reported physical functioning - mobility
Time Frame: Through study completion, approximately 2 years
|
NIH PROMIS questionnaire for mobility using appropriate raw summed, scale or T scores with higher scores indicating better mobility (pediatric - raw 0 to 32, T-score 15.2 to 58.5; adult - raw 8 to 40, T-score 20.9 to 59.7; parent proxy - raw 0 to 32, scale 14 to 56)
|
Through study completion, approximately 2 years
|
Patient reported physical activity level
Time Frame: Through study completion, approximately 2 years
|
NHANES physical activity questionnaire for frequency of moderate versus vigorous physical activity in number of days in typical week (range 0 to 7 days with higher number indicating more days spent in moderate or vigorous activity) and time spent in typical day (0 to > 2 hours with higher number indicating more hours spent in moderate or vigorous activity)
|
Through study completion, approximately 2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Robert Liem, MD, Ann and Robert H. Lurie Childrens Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-881
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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