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

Sponsor

Duke University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05714098

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Arm

70.9

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Sickle Cell Disease	Behavioral: Gerofit Exercise Program	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 30, 2027

Anticipated Study Completion Date :

Dec 30, 2028

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Feasibility, as measured by number of participants completing at least 50% of the exercise sessions [12 weeks]

Secondary Outcome Measures

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

Other Outcome Measures

Change in mobility as measured by Usual Gait Speed [Baseline, 12 weeks]
Change in balance as measured by Timed Up and Go [Baseline, 12 weeks]
Change in aerobic endurance as measured by Six-Minute Walk Test [Baseline, 12 weeks]
Change in upper body strength as measured by grip strength [Baseline, 12 weeks]
Change in lower body strength as measured by 30-second chair stand [Baseline, 12 weeks]
Change in quality of movement measured by functional movement screen [Baseline, 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.