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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Behavioral: Gerofit Exercise Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, as measured by number of participants with moderate or severe adverse events | 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 | Number of participants reporting the intervention as acceptable | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, sickle cell anemia, older adults, geriatrics, functional impairment