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

Duke University30 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sickle Cell Disease

Interventions

Gerofit Exercise ProgramBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Duke University

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Feasibility, as measured by number of participants completing at least 50% of the exercise sessions

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 12 weeks

Acceptability, as measured by acceptability survey

Number of participants reporting the intervention as acceptable

Time frame: 12 weeks

Data from ClinicalTrials.gov

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