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
Investigators will pilot the SickleFit personalized exercise plus dietitian-facilitated nutrition intervention randomized control trial in adults (age ≥ 35 years) with sickle cell disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
SickleFit personalized exercise plus dietitian-facilitated nutrition intervention
Duke University
Durham, North Carolina, United States
RECRUITINGFeasibility of Randomization
Feasibility of randomization (proportion of participants randomized out of those approached)
Time frame: From enrollment to the last paticipants randomized over a 2 year period
Safety/Adverse Events
number of life-threatening adverse events
Time frame: adverse events will be measured for both arms up to 6 months
Acceptability
Proportion of participants reporting satisfaction with the program
Time frame: From enrollment to after completion of the SickleFit Program over 6 months since we will also measure acceptability for control group
Retention in the program
retention (proportion of the SickleFit and control groups completing follow up assessment)
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.
Adherence
Adherence (proportion attending ≥ 50% of classes) in the SickleFit arm
Time frame: From the start of the first SickleFit session to the end of the SickleFit program at 12 weeks
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