Sickle Cell DiseaseNCT07442851
SickleFit Exercise and Nutrition Study
A study testing SickleFit Exercise plus Nutrition in people with Sickle Cell Disease and Aging, run by Duke University at 1 site in United States.
Trial summary
To goal of this study is to pilot the SickleFit exercise and nutrition intervention in adults with sickle cell disease in a randomized control trial Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Sickle Cell Disease, Aging
- What is being tested?
- SickleFit Exercise plus Nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2026to Jan 2028
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laboratory-confirmed diagnosis of sickle cell disease (any genotype)
- Understand and speak English by self-report
- Age ≥ 35 years old
Who cannot join
- Oxygen dependence
- Unstable cardiac disease
- Wheelchair-bound
- Diagnosed with severe cognitive impairment based on ICD-10 codes or reported by their outpatient provider
- Unable to self-consent
- Severe uncorrected visual or auditory impairment
- Pregnant
- Successfully treated with hematopoietic stem cell transplantation or gene therapy for sickle cell disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rania Mohamed contact
United States1 site, 1 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27710
Teagan Callaway, 919-684-0628, teagan.callaway@duke.edu
Rania Mohamed, rania.mohamed@duke.edu
About this study
Official title: The SickleFit Exercise and Nutrition Randomized Control Trial for Older Adults With Sickle Cell Disease
To goal of this study is to pilot the SickleFit exercise and nutrition intervention in adults with sickle cell disease in a randomized control trial
Read the detailed description
Investigators will pilot the SickleFit personalized exercise plus dietitian-facilitated nutrition intervention randomized control trial in adults (age ≥ 35 years) with sickle cell disease.
- Conditions
- Sickle Cell Disease, Aging
- Being tested
- SickleFit Exercise plus Nutrition
- Keywords
- sickle cell disease, exercise, nutrition, aging, functional impairment
- Medical subject headings
- Anemia, Sickle Cell, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SickleFit Exercise plus NutritionBehavioural
SickleFit personalized exercise plus dietitian-facilitated nutrition intervention
| Study group | Role | What they receive |
|---|---|---|
| SickleFit arm | Experimental | Participants in SickleFit arm will complete the Sickle Cell Disease Functional Assessment before and after 12 weeks of SickleFit exeercise+Nutrition intervention. Receives: Behavioral: SickleFit Exercise plus Nutrition |
| Control Arm | No intervention | Participants in the control arm will be on a wait list for SickleFit and will continue to receive usual care during that 12-week period. They will complete the Sickle Cell Disease Functional Assessment at baseline and after 12 weeks on the wait list. After their post-assessment, they will have the option to complete 12 weeks of SickleFit exercise+Nutrition intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Randomization
Feasibility of randomization (proportion of participants randomized out of those approached)
Measured: From enrollment to the last paticipants randomized over a 2 year period
Safety/Adverse Events
number of life-threatening adverse events
Measured: adverse events will be measured for both arms up to 6 months
Acceptability
Proportion of participants reporting satisfaction with the program
Measured: From enrollment to after completion of the SickleFit Program over 6 months since we will also measure acceptability for control group
Retention in the program
retention (proportion of the SickleFit and control groups completing follow up assessment)
Measured: From the baseline Sickle Cell Disease Functional Assessment to the post-SCD-FA. Over a 30 week period since post assessments will be completed within 3 months of completion of the SickleFit program or control period.
Adherence
Adherence (proportion attending ≥ 50% of classes) in the SickleFit arm
Measured: From the start of the first SickleFit session to the end of the SickleFit program at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start8 Apr 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will conduct a 12-week randomized control trial of a combined SickleFit exercise plus dietitian-led nutrition education intervention to be delivered virtual via Zoom in 40 adults (age ≥ 35) with sickle cell disease. There will be 20 participants in the SickleFit arm and 20 participants in the control arm. Randomization will be done 1:1.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charity I Oyedeji, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442851
- Sponsor's protocol ID
- Pro00118037
- Status last verified
- May 2026
- First submitted
- 20 Feb 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Charity I Oyedeji, Teagan Callaway, Rania Mohamed, Reena Ravi, Richard Faldowski, Corey Vessels, Miriam C Morey, John J Strouse; The Sicklefit Exercise Program for Older Adults with Sickle Cell Disease: Feasibility, Acceptability, and Safety. Blood 2024; 144 (Supplement 1): 604. doi: https://doi.org/10.1182/blood-2024-212100
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SickleFit Exercise and Nutrition Randomized Control Trial for Older Adults With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT07442851
- Acronym / sponsor ID
- Pro00118037
- Conditions
- Sickle Cell Disease, Aging
- Keywords
- sickle cell disease, exercise, nutrition, aging, functional impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 2 Mar 2026 (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.
To goal of this study is to pilot the SickleFit exercise and nutrition intervention in adults with sickle cell disease in a randomized control trial
Detailed description
Investigators will pilot the SickleFit personalized exercise plus dietitian-facilitated nutrition intervention randomized control trial in adults (age ≥ 35 years) with sickle cell disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will conduct a 12-week randomized control trial of a combined SickleFit exercise plus dietitian-led nutrition education intervention to be delivered virtual via Zoom in 40 adults (age ≥ 35) with sickle cell disease. There will be 20 participants in the SickleFit arm and 20 participants in the control arm. Randomization will be done 1:1.
| Arm | Type | Receives |
|---|---|---|
| SickleFit arm | Experimental | Behavioral: SickleFit Exercise plus NutritionParticipants in SickleFit arm will complete the Sickle Cell Disease Functional Assessment before and after 12 weeks of SickleFit exeercise+Nutrition intervention. |
| Control Arm | No intervention | –Participants in the control arm will be on a wait list for SickleFit and will continue to receive usual care during that 12-week period. They will complete the Sickle Cell Disease Functional Assessment at baseline and after 12 weeks on the wait list. After their post-assessment, they will have the option to complete 12 weeks of SickleFit exercise+Nutrition intervention. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Laboratory-confirmed diagnosis of sickle cell disease (any genotype)
- Understand and speak English by self-report
- Age ≥ 35 years old
Key exclusion criteria (8 listed)
- Oxygen dependence
- Unstable cardiac disease
- Wheelchair-bound
- Diagnosed with severe cognitive impairment based on ICD-10 codes or reported by their outpatient provider
- Unable to self-consent
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 |
|---|---|---|
| SickleFit Exercise plus NutritionSickleFit personalized exercise plus dietitian-facilitated nutrition intervention | Behavioural | SickleFit arm |
Primary outcome
Feasibility of Randomization
Time frame: From enrollment to the last paticipants randomized over a 2 year period
Feasibility of randomization (proportion of participants randomized out of those approached)
Safety/Adverse Events
Time frame: adverse events will be measured for both arms up to 6 months
number of life-threatening adverse events
Acceptability
Time frame: From enrollment to after completion of the SickleFit Program over 6 months since we will also measure acceptability for control group
Proportion of participants reporting satisfaction with the program
Retention in the program
Time frame: From the baseline Sickle Cell Disease Functional Assessment to the post-SCD-FA. Over a 30 week period since post assessments will be completed within 3 months of completion of the SickleFit program or control period.
retention (proportion of the SickleFit and control groups completing follow up assessment)
Adherence
Time frame: From the start of the first SickleFit session to the end of the SickleFit program at 12 weeks
Adherence (proportion attending ≥ 50% of classes) in the SickleFit arm
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 7 May 2026.
- BackgroundCharity I Oyedeji, Teagan Callaway, Rania Mohamed, Reena Ravi, Richard Faldowski, Corey Vessels, Miriam C Morey, John J Strouse; The Sicklefit Exercise Program for Older Adults with Sickle Cell Disease: Feasibility, Acceptability, and Safety. Blood 2024; 144 (Supplement 1): 604. doi: https://doi.org/10.1182/blood-2024-212100
- 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.
Rania Mohamed contact
Charity I Oyedeji, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SickleFit Exercise plus Nutrition in people with Sickle Cell Disease and Aging, run by Duke University at 1 site 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Teagan Callaway (919-684-0628, SICKLEFIT@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Randomization (time frame: From enrollment to the last paticipants randomized over a 2 year period). 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 NCT07442851, which also lists 1 linked publication.
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 7 May 2026.