SickleFit Exercise and Nutrition Study for Sickle Cell Disease

This study, called SickleFit, is testing a personalized exercise and dietitian-led nutrition program for adults with sickle cell disease. The goal is to see if this program is practical to offer, safe, and acceptable to participants. You might be able to join if you are at least 35 years old, have a laboratory-confirmed diagnosis of sickle cell disease, and can understand and speak English. However, you cannot participate if you need oxygen, have unstable heart disease, use a wheelchair, or have severe cognitive impairment. This study aims to enroll 40 participants.

Study design
This is an interventional study, meaning participants will receive a specific intervention. It is a randomized controlled trial, which means participants are randomly assigned to different groups. The study plans to enroll 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be measured for both groups for up to 6 months after starting the program. Acceptability will also be measured for 6 months.

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NCT07442851

SickleFit Exercise and Nutrition Study

Recruiting
NAAges 35+InterventionalTreatment
Duke University
~40 participants
Updated 2026-05-07 on ClinicalTrials.gov
What's tested:SickleFit Exercise plus Nutrition

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of Randomization
Measured over From enrollment to the last paticipants randomized over a 2 year period
+4 more outcomes measured
Sickle Cell Disease
Aging
1 sites across 1 states
North Carolina1
  • Charity I Oyedeji, MD · PRINCIPAL_INVESTIGATOR · Duke University

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Eligibility criteria

Inclusion

Laboratory-confirmed diagnosis of sickle cell disease (any genotype)
Understand and speak English by self-report
Age ≥ 35 years old

Exclusion

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
  • Feasibility of RandomizationFrom enrollment to the last paticipants randomized over a 2 year period

    Feasibility of randomization (proportion of participants randomized out of those approached)

  • Safety/Adverse Eventsadverse events will be measured for both arms up to 6 months

    number of life-threatening adverse events

  • AcceptabilityFrom 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 programFrom 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)

  • AdherenceFrom 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