SickleFit Exercise and Nutrition Study

May 4, 2026 updated by: Duke University

The SickleFit Exercise and Nutrition Randomized Control Trial for Older Adults With Sickle Cell Disease

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Charity I Oyedeji, MD
        • Sub-Investigator:
          • John J Strouse, MD PhD
        • Sub-Investigator:
          • Kathryn Starr, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: SickleFit Exercise plus Nutrition
SickleFit personalized exercise plus dietitian-facilitated 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Randomization
Time Frame: From enrollment to the last paticipants randomized over a 2 year period
Feasibility of randomization (proportion of participants randomized out of those approached)
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
number of life-threatening adverse events
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
Proportion of participants reporting satisfaction with the program
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.
retention (proportion of the SickleFit and control groups completing follow up assessment)
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
Adherence (proportion attending ≥ 50% of classes) in the SickleFit arm
From the start of the first SickleFit session to the end of the SickleFit program at 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance on the Sickle Cell Disease Functional Assessment (SCD-FA)
Time Frame: From baseline assessment to completion of the post-assessment within 6 months
Change in physical performance and patient-reported outcomes on the Sickle Cell Disease Functional Assessment (SCD-FA)
From baseline assessment to completion of the post-assessment within 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Charity I Oyedeji, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00118037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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