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

January 17, 2024 updated by: victoria marchese, University of Maryland, Baltimore

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
      • Baltimore, Maryland, United States, 21201-1082
        • Recruiting
        • University of Maryland School of Medicine Dept. of Physical Therapy & Rehabilitation Science
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical Therapy Exercise
There will be no control group and only one intervention delivered
Behavioral: SuCCESs
strengthening and endurance exercises

What is the study measuring?

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

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00107858

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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