SickleFit: exercise and nutrition program for adults with sickle cell disease
Official title: The SickleFit Exercise and Nutrition Randomized Control Trial for Older Adults With Sickle Cell Disease
Run by Duke University · NCT07442851 · Data updated 2026-11-12
This program will test whether a personalized exercise plan plus dietitian-guided nutrition helps adults aged 35 and older with sickle cell disease feel and function better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 35 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | April 8, 2026 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | May 7, 2026 |
| Trial ID | NCT07442851 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 35 or older with a laboratory-confirmed diagnosis of sickle cell disease who speak English and can provide informed consent.
✕Probably not a fit
Patients who are oxygen-dependent, wheelchair-bound, have unstable cardiac disease, severe cognitive or sensory impairment, are pregnant, or who have undergone curative stem cell transplant or gene therapy are unlikely to benefit or are ineligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Investigators will pilot a personalized exercise program combined with dietitian-facilitated nutrition counseling in adults aged 35 and older who have laboratory-confirmed sickle cell disease. Participants will be randomized to receive the SickleFit intervention or usual care to compare safety, feasibility, and functional outcomes. The exercise plan is tailored to each participant's abilities and the nutrition component is delivered by a dietitian, with progress and adverse events monitored during the study period. The pilot is designed to generate preliminary data to inform larger trials in this aging sickle cell population.
Why it matters
Potential benefit: If successful, the intervention could improve physical function, reduce age-related decline, and enhance quality of life for older adults with sickle cell disease.
How similar studies have gone: Exercise and nutrition programs have shown benefits in other chronic conditions and small feasibility studies in sickle cell disease suggest potential, but randomized evidence in older adults with sickle cell disease is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Laboratory-confirmed diagnosis of sickle cell disease (any genotype) * Understand and speak English by self-report * Age ≥ 35 years old Exclusion Criteria: * 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
Where it's running
-
Duke University
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Charity I Oyedeji, MD — Duke University
- Study coordinator: Teagan Callaway
- Email: SICKLEFIT@duke.edu
- Phone: 919-684-0628
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.