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

Not Applicable

Recruiting

• Conditions: Sickle Cell Disease
• Interventions: Behavioral: Gerofit Exercise Program

• Registration Number: NCT05714098
• Lead Sponsor: Duke University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-02-06
• Study Start: 2023-03-27
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23
• Primary Completion: 2027-12-30
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise	Gerofit Exercise Program	Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual

Primary Outcome Measures

Name	Time	Method
Feasibility, as measured by number of participants completing at least 50% of the exercise sessions	12 weeks

Secondary Outcome Measures

Name	Time	Method
Safety, as measured by number of participants with moderate or severe adverse events	12 weeks	Number of participants with 1 or more moderate or severe adverse events within 48 hours after each exercise session
Acceptability, as measured by acceptability survey	12 weeks	Number of participants reporting the intervention as acceptable

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States