Sickle Cell Children's Exercise Study (SuCCESs)

Sickle Cell Disease Clinical Trial

— SuCCESs  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074198
• Other study ID #: HP-00107858
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: University of Maryland, Baltimore
• Contact: Victoria G Marchese, PhD
• Phone: 410-706-7979
• Email: vmarchese[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Sickle Cell Children's Exercise Study (SuCCESs) will explore the feasibility and effects of a moderate intensity strengthening, balance, speed, and agility intervention program in children with sickle cell disease.

Description:

Participants will perform the baseline assessment and after six weeks of performing the SuCCESs program the participants will perform a post-intervention assessment. Participants will be asked to attend a total of six physical therapy in-person sessions (1x/week) at the University of Maryland Department of Physical Therapy and Rehabilitation Science and to perform 12 home program sessions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Behavioral:
• SuCCESs
strengthening and endurance exercises

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine Dept. of Physical Therapy & Rehabilitation Science	Baltimore	Maryland
United States	University of Maryland, Baltimore	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knee extension strength	dynamometry to measure knee extension strength	week 1 and week 7
Primary	Rate of Muscle Activation	Electromyography used to measure rate of muscle activation	week 1 and week 7
Primary	exercise tolerance	6-Minute Walk Test used to measure exercise tolerance	week 1 and week 7
Primary	locomotor efficiency	oxygen uptake used to measure locomotor efficiency	week 1 and week 7
Primary	number of sessions attended	attendance	throughout the entire study week 1, weeks 2-6, six weeks of intervention, and week 7