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Sickle Cell Children's Exercise Study (SuCCESs)

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06074198
Collaborator
(none)
20
Enrollment
1
Arm
23
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: SuCCESs
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
feasibility studyfeasibility 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.
Primary Purpose:
Treatment
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.
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Physical Therapy Exercise

There will be no control group and only one intervention delivered

Behavioral: SuCCESs
strengthening and endurance exercises

Outcome Measures

Primary Outcome Measures

  1. knee extension strength [week 1 and week 7]

    dynamometry to measure knee extension strength

  2. Rate of Muscle Activation [week 1 and week 7]

    Electromyography used to measure rate of muscle activation

  3. exercise tolerance [week 1 and week 7]

    6-Minute Walk Test used to measure exercise tolerance

  4. locomotor efficiency [week 1 and week 7]

    oxygen uptake used to measure locomotor efficiency

  5. number of sessions attended [throughout the entire study week 1, weeks 2-6, six weeks of intervention, and week 7]

    attendance

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Maryland, Baltimore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
victoria marchese, professor, Chair, University of Maryland, Baltimore
ClinicalTrials.gov Identifier:
NCT06074198
Other Study ID Numbers:
  • HP-00107858
First Posted:
Oct 10, 2023
Last Update Posted:
Oct 10, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by victoria marchese, professor, Chair, University of Maryland, Baltimore
physical therapy
neuromotor performance
functional capacity
Additional relevant MeSH terms:
Anemia, Sickle Cell

Study Results

No Results Posted as of Oct 10, 2023