NCT07442851 · Duke University
SickleFit Exercise and Nutrition Study
What this study is about
To goal of this study is to pilot the SickleFit exercise and nutrition intervention in adults with sickle cell disease in a randomly assigned control trial
View original scientific description
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
Interventions
BEHAVIORAL
SickleFit Exercise plus Nutrition
SickleFit personalized exercise plus dietitian-facilitated nutrition intervention
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Successfully treated with hematopoietic stem cell transplantation or gene therapy for sickle cell disease
Where
- Durham, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 7, 2026 · Source of record for eligibility and locations