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

October 24, 2025 updated by: Duke University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

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 Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual
Behavioral: Gerofit Exercise Program
The tele-Gerofit exercise intervention has training focused on meeting the physical activity guidelines and incorporating cardiovascular, strength, and balance training. Sessions will also include a mindfulness component, warm up, cool-down, and safety checks. Exercises are personalized to each person's functional status. Intensity of exercises will be determined by participants providing a rating of perceived exertion (RPE) on a scale of 0 (easy) to 10 (very hard) throughout the session. Initial exercise sessions will start at low-intensity and will gradually increase the duration and intensity to allow each person to reach recommended exercise levels at their own pace. Exercises are done virtually via Zoom. Each cohort will have 5-8 participants. The exercise program will be optimized after each cohort with modifications based on participant and exercise expert feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility, as measured by number of participants completing at least 50% of the exercise sessions
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Change in mobility as measured by Usual Gait Speed
Time Frame: Baseline, 12 weeks, 24 weeks
Baseline, 12 weeks, 24 weeks
Change in balance as measured by Timed Up and Go
Time Frame: Baseline, 12 weeks, 24 weeks
Baseline, 12 weeks, 24 weeks
Change in aerobic endurance as measured by Six-Minute Walk Test
Time Frame: Baseline, 12 weeks, 24 weeks
Baseline, 12 weeks, 24 weeks
Change in upper body strength as measured by grip strength
Time Frame: Baseline, 12 weeks, 24 weeks
Baseline, 12 weeks, 24 weeks
Change in lower body strength as measured by 30-second chair stand
Time Frame: Baseline, 12 weeks, 24 weeks
Baseline, 12 weeks, 24 weeks
Change in quality of movement measured by functional movement screen
Time Frame: Baseline, 12 weeks. 24 weeeks
Baseline, 12 weeks. 24 weeeks

Collaborators and Investigators

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

Sponsor

Duke University

Collaborators

National Institutes of Health (NIH)

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

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)

March 27, 2023

Primary Completion (Actual)

May 30, 2025

Study Completion (Actual)

August 8, 2025

Study Registration Dates

First Submitted

January 18, 2023

First Submitted That Met QC Criteria

January 30, 2023

First Posted (Actual)

February 6, 2023

Study Record Updates

Last Update Posted (Estimated)

October 27, 2025

Last Update Submitted That Met QC Criteria

October 24, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00111833

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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