Sickle Cell DiseaseSuCCESsNCT06074198
Sickle Cell Children's Exercise Study (SuCCESs)
A study testing SuCCESs in people with Sickle Cell Disease, run by University of Maryland, Baltimore at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- SuCCESs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Nov 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 6-17 years of age diagnosed with sickle cell disease
Who cannot join
- Diagnosis of neurological disorder, not related to sickle cell disease
- Lower extremity injury such as a fracture with a cast
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland School of Medicine Dept. of Physical Therapy & Rehabilitation Science
Baltimore, Maryland, 21201-1082
University of Maryland, Baltimore
Baltimore, Maryland, 21201
About this study
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.
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.
Read the 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.
- Conditions
- Sickle Cell Disease
- Being tested
- SuCCESs
- Keywords
- physical therapy, neuromotor performance, functional capacity
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuCCESsBehavioural
strengthening and endurance exercises
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy Exercise | Experimental | There will be no control group and only one intervention delivered Receives: Behavioral: SuCCESs |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee extension strength
dynamometry to measure knee extension strength
Measured: week 1 and week 7
Rate of Muscle Activation
Electromyography used to measure rate of muscle activation
Measured: week 1 and week 7
exercise tolerance
6-Minute Walk Test used to measure exercise tolerance
Measured: week 1 and week 7
locomotor efficiency
oxygen uptake used to measure locomotor efficiency
Measured: week 1 and week 7
number of sessions attended
attendance
Measured: throughout the entire study week 1, weeks 2-6, six weeks of intervention, and week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start3 Nov 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- feasibility study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, victoria marchese, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074198
- Sponsor's protocol ID
- HP-00107858
- Acronym
- SuCCESs
- Status last verified
- Feb 2026
- First submitted
- 28 Sep 2023
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34592159Lanza 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.
PubMed 34721067Ho 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.
PubMed 36843306Rock 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.
PubMed 33563044
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06074198
- Acronym / sponsor ID
- SuCCESs / HP-00107858
- Conditions
- Sickle Cell Disease
- Keywords
- physical therapy, neuromotor performance, functional capacity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- feasibility study
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy Exercise | Experimental | Behavioral: SuCCESsThere will be no control group and only one intervention delivered |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 6-17 years of age diagnosed with sickle cell disease
Key exclusion criteria (2 listed)
- Diagnosis of neurological disorder, not related to sickle cell disease
- Lower extremity injury such as a fracture with a cast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuCCESsstrengthening and endurance exercises | Behavioural | Physical Therapy Exercise |
Primary outcome
knee extension strength
Time frame: week 1 and week 7
dynamometry to measure knee extension strength
Rate of Muscle Activation
Time frame: week 1 and week 7
Electromyography used to measure rate of muscle activation
exercise tolerance
Time frame: week 1 and week 7
6-Minute Walk Test used to measure exercise tolerance
locomotor efficiency
Time frame: week 1 and week 7
oxygen uptake used to measure locomotor efficiency
number of sessions attended
Time frame: throughout the entire study week 1, weeks 2-6, six weeks of intervention, and week 7
attendance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 34592159Marchese 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.
- Background: PubMed 34721067Lanza 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.
- Background: PubMed 36843306Ho 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.
- Background: PubMed 33563044Rock 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SuCCESs in people with Sickle Cell Disease, run by University of Maryland, Baltimore at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee extension strength (time frame: week 1 and week 7). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06074198, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.