SickleFit Exercise and Nutrition for Sickle Cell Disease

Overseen By Rania Mohamed

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Oxygen dependence, Unstable cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Charity I Oyedeji, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

Inclusion Criteria

Understand and speak English by self-report

I have been diagnosed with sickle cell disease.

I am 35 years old or older.

Exclusion Criteria

I have been cured of sickle cell disease with stem cell transplant or gene therapy.

I need to use oxygen regularly.

Diagnosed with severe cognitive impairment based on ICD-10 codes or reported by their outpatient provider

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the SickleFit arm undergo a 12-week exercise and nutrition intervention

12 weeks

Regular sessions (frequency not specified)

Control Period

Participants in the control arm are on a wait list and receive usual care for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Optional SickleFit Extension

Control group participants have the option to complete 12 weeks of SickleFit exercise and nutrition intervention after the control period

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SickleFit Exercise plus Nutrition

How Is the Trial Designed?

Group I: SickleFit arm Experimental Treatment 1 Intervention

Participants in SickleFit arm will complete the Sickle Cell Disease Functional Assessment before and after 12 weeks of SickleFit exeercise+Nutrition intervention.

Group II: Control Arm Active Control 1 Intervention

Participants in the control arm will be on a wait list for SickleFit and will continue to receive usual care during that 12-week period. They will complete the Sickle Cell Disease Functional Assessment at baseline and after 12 weeks on the wait list. After their post-assessment, they will have the option to complete 12 weeks of SickleFit exercise+Nutrition intervention.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+