Sickle Cell Children's Exercise Study (SuCCESs) (SuCCESs)
Sickle Cell Children's Exercise Study Determining the Effects of a Targeted Exercise Training Program on Neuromuscular Performance, Locomotor Efficiency, and Exercise Tolerance in Children With Sickle Cell Disease.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Victoria G Marchese, PhD
- Phone Number: 410-706-7979
- Email: vmarchese@som.umaryland.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland, Baltimore
-
Baltimore, Maryland, United States, 21201-1082
- University of Maryland School of Medicine Dept. of Physical Therapy & Rehabilitation Science
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children 6-17 years of age diagnosed with sickle cell disease
Exclusion Criteria:
- Diagnosis of neurological disorder, not related to sickle cell disease
- Lower extremity injury such as a fracture with a cast
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Physical Therapy Exercise
There will be no control group and only one intervention delivered
|
strengthening and endurance exercises
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
knee extension strength
Time Frame: week 1 and week 7
|
dynamometry to measure knee extension strength
|
week 1 and week 7
|
|
Rate of Muscle Activation
Time Frame: week 1 and week 7
|
Electromyography used to measure rate of muscle activation
|
week 1 and week 7
|
|
exercise tolerance
Time Frame: week 1 and week 7
|
6-Minute Walk Test used to measure exercise tolerance
|
week 1 and week 7
|
|
locomotor efficiency
Time Frame: week 1 and week 7
|
oxygen uptake used to measure locomotor efficiency
|
week 1 and week 7
|
|
number of sessions attended
Time Frame: throughout the entire study week 1, weeks 2-6, six weeks of intervention, and week 7
|
attendance
|
throughout the entire study week 1, weeks 2-6, six weeks of intervention, and week 7
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- Marchese V, Rock K, Harpold A, Salazar A, Williams M, Shipper AG. Physical Impairment and Function in Children and Adolescents With Sickle Cell Disease: A Systematic Review. Arch Phys Med Rehabil. 2022 Jun;103(6):1144-1167.e2. doi: 10.1016/j.apmr.2021.08.022. Epub 2021 Sep 27.
- Lanza MB, Rock K, Marchese V, Addison O, Gray VL. Hip Abductor and Adductor Rate of Torque Development and Muscle Activation, but Not Muscle Size, Are Associated With Functional Performance. Front Physiol. 2021 Oct 14;12:744153. doi: 10.3389/fphys.2021.744153. eCollection 2021.
- Ho S, Rock K, Marchese V. Diaphragm excursion correlates with performance and ventilation on the 6-min walk test in children with sickle cell disease. Pediatr Pulmonol. 2023 Jun;58(6):1665-1673. doi: 10.1002/ppul.26373. Epub 2023 Mar 8.
- Rock K, Nelson C, Addison O, Marchese V. Assessing the Reliability of Handheld Dynamometry and Ultrasonography to Measure Quadriceps Strength and Muscle Thickness in Children, Adolescents, and Young Adults. Phys Occup Ther Pediatr. 2021;41(5):540-554. doi: 10.1080/01942638.2021.1881200. Epub 2021 Feb 9.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- HP-00107858
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
product manufactured in and exported from the U.S.
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.