Aging, Sickle Cell Disease
Conditions
Keywords
sickle cell disease, exercise, nutrition, aging, functional impairment
Brief summary
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
Detailed description
Investigators will pilot the SickleFit personalized exercise plus dietitian-facilitated nutrition intervention randomized control trial in adults (age ≥ 35 years) with sickle cell disease.
Interventions
BEHAVIORALSickleFit Exercise plus Nutrition
SickleFit personalized exercise plus dietitian-facilitated nutrition intervention
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
We will conduct a 12-week randomized control trial of a combined SickleFit exercise plus dietitian-led nutrition education intervention to be delivered virtual via Zoom in 40 adults (age ≥ 35) with sickle cell disease. There will be 20 participants in the SickleFit arm and 20 participants in the control arm. Randomization will be done 1:1.
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTTeagan Callaway
CONTACTRania Mohamed
PRINCIPAL_INVESTIGATORCharity I Oyedeji, MD
Duke University
Outcome results
None listed