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NCT Number: NCT07442851

SickleFit Exercise and Nutrition Study

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

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Key information

Conditions

Sickle Cell Disease Aging Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Motor Activity

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27710, United States

Location status: Recruiting

About this study

Investigators will pilot the SickleFit personalized exercise plus dietitian-facilitated nutrition intervention randomized control trial in adults (age ≥ 35 years) with sickle cell disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SickleFit Exercise plus Nutrition

Behavioral

SickleFit personalized exercise plus dietitian-facilitated nutrition intervention

Primary outcomes

  1. 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)

  2. Safety/Adverse Events

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

    number of life-threatening adverse events

  3. 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

  4. 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)

  5. 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

Other outcomes

  1. 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)

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 2, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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