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

Sickle Cell Disease Clinical Trial

— SICKLE-FIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05714098
• Other study ID #: Pro00111833
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2023
• Est. completion date: December 30, 2028

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: Charity I Oyedeji, MD
• Phone: 9196840628
• Email: charity.oyedeji[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2028
• Est. primary completion date: December 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (8)

Liem RI, Akinosun M, Muntz DS, Thompson AA. Feasibility and safety of home exercise training in children with sickle cell anemia. Pediatr Blood Cancer. 2017 Dec;64(12). doi: 10.1002/pbc.26671. Epub 2017 Jun 9. — View Citation

Liem RI. Balancing exercise risk and benefits: lessons learned from sickle cell trait and sickle cell anemia. Hematology Am Soc Hematol Educ Program. 2018 Nov 30;2018(1):418-425. doi: 10.1182/asheducation-2018.1.418. — View Citation

Merlet AN, Messonnier LA, Coudy-Gandilhon C, Bechet D, Gellen B, Rupp T, Galacteros F, Bartolucci P, Feasson L. Beneficial effects of endurance exercise training on skeletal muscle microvasculature in sickle cell disease patients. Blood. 2019 Dec 19;134(25):2233-2241. doi: 10.1182/blood.2019001055. — View Citation

Morey MC, Cowper PA, Feussner JR, DiPasquale RC, Crowley GM, Kitzman DW, Sullivan RJ Jr. Evaluation of a supervised exercise program in a geriatric population. J Am Geriatr Soc. 1989 Apr;37(4):348-54. doi: 10.1111/j.1532-5415.1989.tb05503.x. — View Citation

Morey MC, Lee CC, Castle S, Valencia WM, Katzel L, Giffuni J, Kopp T, Cammarata H, McDonald M, Oursler KA, Wamsley T, Jain C, Bettger JP, Pearson M, Manning KM, Intrator O, Veazie P, Sloane R, Li J, Parker DC. Should Structured Exercise Be Promoted As a Model of Care? Dissemination of the Department of Veterans Affairs Gerofit Program. J Am Geriatr Soc. 2018 May;66(5):1009-1016. doi: 10.1111/jgs.15276. Epub 2018 Feb 12. — View Citation

Morey MC, Pieper CF, Crowley GM, Sullivan RJ, Puglisi CM. Exercise adherence and 10-year mortality in chronically ill older adults. J Am Geriatr Soc. 2002 Dec;50(12):1929-33. doi: 10.1046/j.1532-5415.2002.50602.x. — View Citation

Oyedeji C, Strouse JJ, Crawford RD, Garrett ME, Ashley-Koch AE, Telen MJ. A multi-institutional comparison of younger and older adults with sickle cell disease. Am J Hematol. 2019 Apr;94(4):E115-E117. doi: 10.1002/ajh.25405. Epub 2019 Jan 31. No abstract available. — View Citation

Oyedeji CI, Hall K, Luciano A, Morey MC, Strouse JJ. The Sickle Cell Disease Functional Assessment (SCD-FA) tool: a feasibility pilot study. Pilot Feasibility Stud. 2022 Mar 4;8(1):53. doi: 10.1186/s40814-022-01005-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in mobility as measured by Usual Gait Speed		Baseline, 12 weeks
Other	Change in balance as measured by Timed Up and Go		Baseline, 12 weeks
Other	Change in aerobic endurance as measured by Six-Minute Walk Test		Baseline, 12 weeks
Other	Change in upper body strength as measured by grip strength		Baseline, 12 weeks
Other	Change in lower body strength as measured by 30-second chair stand		Baseline, 12 weeks
Other	Change in quality of movement measured by functional movement screen		Baseline, 12 weeks
Primary	Feasibility, as measured by number of participants completing at least 50% of the exercise sessions		12 weeks
Secondary	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
Secondary	Acceptability, as measured by acceptability survey	Number of participants reporting the intervention as acceptable	12 weeks