NCT06074198

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Nov 2023Dec 2026

First Submitted

Initial submission to the registry

September 28, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

November 3, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

April 21, 2026

Status Verified

February 1, 2026

Enrollment Period

2.2 years

First QC Date

September 28, 2023

Last Update Submit

April 16, 2026

Conditions

Sickle Cell Disease

Keywords

physical therapyneuromotor performancefunctional capacity

Outcome Measures

Primary Outcomes (5)

  • knee extension strength

    dynamometry to measure knee extension strength

    week 1 and week 7

  • Rate of Muscle Activation

    Electromyography used to measure rate of muscle activation

    week 1 and week 7

  • exercise tolerance

    6-Minute Walk Test used to measure exercise tolerance

    week 1 and week 7

  • locomotor efficiency

    oxygen uptake used to measure locomotor efficiency

    week 1 and week 7

  • number of sessions attended

    attendance

    throughout the entire study week 1, weeks 2-6, six weeks of intervention, and week 7

Study Arms (1)

Physical Therapy Exercise

EXPERIMENTAL

There will be no control group and only one intervention delivered

Behavioral: SuCCESs

Interventions

SuCCESsBEHAVIORAL

strengthening and endurance exercises

Physical Therapy Exercise

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 6-17 years of age diagnosed with sickle cell disease

You may not qualify if:

  • Diagnosis of neurological disorder, not related to sickle cell disease
  • Lower extremity injury such as a fracture with a cast

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Baltimore, Maryland, 21201-1082, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Related Publications (4)

  • 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.

    PMID: 34592159BACKGROUND

  • 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.

    PMID: 34721067BACKGROUND

  • 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.

    PMID: 36843306BACKGROUND

  • 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.

    PMID: 33563044BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
One physical therapist will perform the pre- and post-test assessment measures and another pediatric physical therapist will perform the intervention sessions.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: feasibility study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor, Chair

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 10, 2023

Study Start

November 3, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

April 21, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)