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Gerofit Exercise Intervention for Older Adults With Sickle Cell Disease (SICKLE-FIT Study)

Duke University logo

Duke University

Status

Completed

Conditions

Sickle Cell Disease

Treatments

Behavioral: Gerofit Exercise Program

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05714098
Pro00111833

Details and patient eligibility

About

The purpose of this study to assess the feasibility, acceptability, and safety of a personalized exercise training program adapted from Gerofit to improve physical health and quality of life for adults with SCD

Full description

The purpose of this study is to adapt and pilot the Gerofit personalized exercise intervention for older adults with sickle cell disease (age ≥ 40 years). The Sickle Cell Disease Functional Assessment (SCD-FA) will be performed at steady state at baseline and every 3 months to track progress. Endpoints include feasibility, acceptability, and safety. All participants will be interviewed to identify barriers and facilitators to exercise and how to better optimize the exercise intervention.

Enrollment

30 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Have a diagnosis of sickle cell disease (any genotype) confirmed by hemoglobin electrophoresis, high performance liquid chromatography, or genotyping
  • Understand and speak fluent English.

Exclusion criteria

  • Diagnosed with moderate or severe cognitive impairment based on ICD-10 codes or report from their outpatient provider
  • Unable to self-consent
  • Wheelchair-bound
  • Successfully treated with hematopoietic stem cell transplantation for SCD
  • Have moderate to severe uncorrected visual or auditory impairment
  • Oxygen-dependent
  • Pregnant
  • Have severe avascular necrosis requiring an assist device
  • Unstable cardiac disease.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Exercise
Experimental group
Description:
Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual
Treatment:
Behavioral: Gerofit Exercise Program

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Charity I Oyedeji, MD; John J. Strouse, MD, PhD

Data sourced from clinicaltrials.gov

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