SickleFit Exercise and Nutrition Study

NCT07442851 | Recruiting

• 1 other identifier: Pro00118037
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Feasibility of Randomization

  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

  number of life-threatening adverse events

  adverse events will be measured for both arms up to 6 months

• Acceptability

  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

  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

  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 Outcomes (1)

• Performance on the Sickle Cell Disease Functional Assessment (SCD-FA)

  From baseline assessment to completion of the post-assessment within 6 months

Study Arms (2)

SickleFit arm

EXPERIMENTAL

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

Control Arm

NO 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.

Interventions

SickleFit Exercise plus Nutrition BEHAVIORAL

SickleFit personalized exercise plus dietitian-facilitated nutrition intervention

SickleFit arm

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Laboratory-confirmed diagnosis of sickle cell disease (any genotype)
• Understand and speak English by self-report
• Age ≥ 35 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Motor Activity

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Charity I Oyedeji, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teagan Callaway

CONTACT

919-684-0628; SICKLEFIT@duke.edu

Rania Mohamed

CONTACT

rania.mohamed@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 2, 2026
• Study Start: April 8, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)