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Sickle Cell Children's Exercise Study (SuCCESs) (SuCCESs)

Primary Purpose

Sickle Cell Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SuCCESs
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease focused on measuring physical therapy, neuromotor performance, functional capacity

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Physical Therapy Exercise

    Arm Description

    There will be no control group and only one intervention delivered

    Outcomes

    Primary Outcome Measures

    knee extension strength
    dynamometry to measure knee extension strength
    Rate of Muscle Activation
    Electromyography used to measure rate of muscle activation
    exercise tolerance
    6-Minute Walk Test used to measure exercise tolerance
    locomotor efficiency
    oxygen uptake used to measure locomotor efficiency
    number of sessions attended
    attendance

    Secondary Outcome Measures

    Full Information

    First Posted
    September 28, 2023
    Last Updated
    October 5, 2023
    Sponsor
    University of Maryland, Baltimore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06074198
    Brief Title
    Sickle Cell Children's Exercise Study (SuCCESs)
    Acronym
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    October 31, 2024 (Anticipated)
    Study Completion Date
    October 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Maryland, Baltimore

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sickle Cell Disease
    Keywords
    physical therapy, neuromotor performance, functional capacity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    feasibility study
    Masking
    None (Open Label)
    Masking Description
    One physical therapist will perform the pre- and post-test assessment measures and another pediatric physical therapist will perform the intervention sessions.
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Physical Therapy Exercise
    Arm Type
    Experimental
    Arm Description
    There will be no control group and only one intervention delivered
    Intervention Type
    Behavioral
    Intervention Name(s)
    SuCCESs
    Intervention Description
    strengthening and endurance exercises
    Primary Outcome Measure Information:
    Title
    knee extension strength
    Description
    dynamometry to measure knee extension strength
    Time Frame
    week 1 and week 7
    Title
    Rate of Muscle Activation
    Description
    Electromyography used to measure rate of muscle activation
    Time Frame
    week 1 and week 7
    Title
    exercise tolerance
    Description
    6-Minute Walk Test used to measure exercise tolerance
    Time Frame
    week 1 and week 7
    Title
    locomotor efficiency
    Description
    oxygen uptake used to measure locomotor efficiency
    Time Frame
    week 1 and week 7
    Title
    number of sessions attended
    Description
    attendance
    Time Frame
    throughout the entire study week 1, weeks 2-6, six weeks of intervention, and week 7

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34592159
    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.
    Results Reference
    background
    PubMed Identifier
    34721067
    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.
    Results Reference
    background
    PubMed Identifier
    36843306
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33563044
    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.
    Results Reference
    background

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    Sickle Cell Children's Exercise Study (SuCCESs)

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