Recruiting

SickleFit

Sponsor:

Duke University

Code:

NCT07442851

Conditions

Sickle Cell Disease

Aging

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

Interventions

SickleFit Exercise plus Nutrition

Study Details

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

Conditions

Sickle Cell Disease

Aging

Study ID

NCT07442851

Start date

Apr 8, 2026

Status verified date

May, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SickleFit arm

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

no intervention: Control Arm

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.

Interventions

SickleFit Exercise plus Nutrition

SickleFit personalized exercise plus dietitian-facilitated nutrition intervention

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Teagan Callaway

919-684-0628SICKLEFIT@duke.edu

Rania Mohamed

rania.mohamed@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Teagan Callaway

919-684-0628teagan.callaway@duke.edu

Rania Mohamed

rania.mohamed@duke.edu

Principal Investigator:

Charity I Oyedeji, MD

More Information

Sponsor

Duke University

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • sickle cell disease
  • exercise
  • nutrition
  • aging
  • functional impairment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-05-07.