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Sickle Cell Children's Exercise Study (SuCCESs)

NCT ID: NCT06074198

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-03

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Sickle Cell Disease

Keywords

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physical therapy neuromotor performance functional capacity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

feasibility study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

One physical therapist will perform the pre- and post-test assessment measures and another pediatric physical therapist will perform the intervention sessions.

Study Groups

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Physical Therapy Exercise

There will be no control group and only one intervention delivered

Group Type EXPERIMENTAL

SuCCESs

Intervention Type BEHAVIORAL

strengthening and endurance exercises

Interventions

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SuCCESs

strengthening and endurance exercises

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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victoria marchese

professor, Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Maryland School of Medicine Dept. of Physical Therapy & Rehabilitation Science

Baltimore, Maryland, United States

Site Status RECRUITING

University of Maryland, Baltimore

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Victoria G Marchese, PhD

Role: CONTACT

Phone: 410-706-7979

Email: [email protected]

Facility Contacts

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Janice N Abarro, BS

Role: primary

Victoria G Marchese, PhD

Role: primary

Melissa Roane

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 34592159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34721067 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36843306 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33563044 (View on PubMed)

Other Identifiers

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HP-00107858

Identifier Type: -

Identifier Source: org_study_id