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Completed

NCT Number: NCT05714098

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

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

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Key information

Conditions

Sickle Cell Disease 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

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Gerofit Exercise Program

Behavioral

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.

Primary outcomes

  1. Feasibility, as Measured by Number of Participants Completing at Least 50% of the Exercise Sessions

    Time frame: 12 weeks

Secondary outcomes

  1. Safety, as Measured by Number of Participants With Moderate or Severe Adverse Events

    Time frame: 12 weeks

    Number of participants with one or more moderate or severe adverse events within 48 hours after each exercise session.

  2. Acceptability, as Measured by the Number of Participants Reporting the Intervention as Acceptable

    Time frame: 12 weeks

    Acceptability of the exercise program was measured on a scale of 1-10, where 1= severe dislike and 10 = absolute enjoyment. Reported as the number of participants with scores of 8-10.

Other outcomes

  1. Percent of Participants With Clinically Meaningful Change in Mobility as Measured by Usual Gait Speed

    Time frame: Baseline, 24 weeks

    Reported as the percent change in usual walking speed on a 4.57 meter (15 feet) walking course.

  2. Percent of Participants With Clinically Meaningful Change in Balance as Measured by Timed Up and Go

    Time frame: Baseline, 12-24 weeks

    Performance test of physical mobility. This measures the number of seconds it takes to stand up from a standard chair (46cm), walk a distance of 10 ft (3 meters), turn back to the chair, and sit down again.

  3. Percent of Participants With Clinically Meaningful Change in Aerobic Endurance as Measured by Six-Minute Walk Test (6MWT)

    Time frame: Baseline, 12-24 weeks

    Measure of aerobic endurance. The participant walks as fast and as safely as possible for 6 minutes with prompts given every minute. Distance traveled in 6 minutes is recorded.

  4. Percent of Participants With Clinically Meaningful Change in Upper Body Strength as Measured by Grip Strength

    Time frame: Baseline, 12-24 weeks

    Measure of upper body strength. Jamar hydraulic hand dynamometer (Jamar Technologies) was used to measure grip strength in triplicate for both hands while subject remains seated. The greatest value was used in analysis.

  5. Percent of Participants With Clinically Meaningful Change in Lower Body Strength as Measured by 30-second Chair Stand

    Time frame: Baseline, 12-24 weeks

    30-second chair stand is a measure lower body strength. The participant sits in a folding chair without arms with chair pressed against the wall and stands up and sits back down with arms across their chest as many times as possible in 30 seconds.

  6. Percent of Participants With Improved Quality of Movement Measured by Functional Movement Screen

    Time frame: Baseline, 12-24 weeks

    Includes deep squat and mobility test of upper and lower extremities. This is measure of squat quality/form.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Acronym: SICKLE-FIT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2023
Registry last updated
Jun 30, 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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