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

NCT05714098 | Completed

• 1 other identifier: Pro00111833
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Sickle Cell Disease

Keywords

sickle cell anemia; older adults; exercise; geriatrics; functional impairment

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (2)

• Safety, as measured by number of participants with moderate or severe adverse events

  12 weeks

• Acceptability, as measured by acceptability survey

  12 weeks

Other Outcomes (6)

• Change in mobility as measured by Usual Gait Speed

  Baseline, 12 weeks, 24 weeks

• Change in balance as measured by Timed Up and Go

  Baseline, 12 weeks, 24 weeks

• Change in aerobic endurance as measured by Six-Minute Walk Test

  Baseline, 12 weeks, 24 weeks

Study Arms (1)

Exercise

EXPERIMENTAL

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

Interventions

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.

Exercise

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnosis of sickle cell disease (any genotype) confirmed by hemoglobin electrophoresis, high performance liquid chromatography, or genotyping
• Understand and speak fluent English.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (8)

• 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.

  PMID: 29430642 BACKGROUND

• 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.

  PMID: 35246265 BACKGROUND

• 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.

  PMID: 12473002 BACKGROUND

• 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.

  PMID: 2921457 BACKGROUND

• 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.

  PMID: 30663090 BACKGROUND

• 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.

  PMID: 30504341 BACKGROUND

• 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.

  PMID: 31742587 BACKGROUND

• 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.

  PMID: 28598539 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Motor Activity

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Study Officials

• Charity I Oyedeji, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 6, 2023
• Study Start: March 27, 2023
• Primary Completion: May 30, 2025
• Study Completion: August 8, 2025
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)