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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
SickleFit Exercise and Nutrition Study
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Charity I Oyedeji, MD · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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