SickleFit Exercise and Nutrition Study

Investigators will pilot the SickleFit personalized exercise plus dietitian-facilitated nutrition intervention randomized control trial in adults (age ≥ 35 years) with sickle cell disease.

• SickleFit Exercise plus Nutrition (Behavioral): SickleFit personalized exercise plus dietitian-facilitated nutrition intervention

Primary outcomes

• Feasibility of Randomization [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 [adverse events will be measured for both arms up to 6 months]: number of life-threatening adverse events
• Acceptability [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 [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 [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

Other outcomes

• Performance on the Sickle Cell Disease Functional Assessment (SCD-FA) [From baseline assessment to completion of the post-assessment within 6 months]: Change in physical performance and patient-reported outcomes on the Sickle Cell Disease Functional Assessment (SCD-FA)

Sex: All, ages: 35 Years to any

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

• 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

• Charity I Oyedeji, MD, Principal investigator, Duke University