SickleFit Exercise and Nutrition Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SickleFit Exercise plus Nutrition.
- Who it may be relevant to
- Registry conditions: Sickle Cell Disease, Aging. Basic parameters: from 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The SickleFit Exercise and Nutrition Randomized Control Trial for Older Adults With Sickle Cell Disease
Overview
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
- 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]
- Safety/Adverse Events [Time frame: adverse events will be measured for both arms up to 6 months]
- Acceptability [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 [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 [Time frame: From the start of the first SickleFit session to the end of the SickleFit program at 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke University — Durham
Publications
- 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
Identifiers
NCT: NCT07442851 · Pro00118037