Clinical trial NCT05714098: Gerofit Exercise Intervention for Older Adults With Sickle Cell Disease (SICKLE-FIT Study)
Official title: Gerofit Exercise Intervention for Older Adults With Sickle Cell Disease (SICKLE-FIT Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sickle Cell Disease
Keywords: sickle cell anemia
older adults
exercise
geriatrics
functional impairment
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility, as measured by number of participants completing at least 50% of the exercise sessions
timeFrame: 12 weeks
Secondary outcomes:
measure: Safety, as measured by number of participants with moderate or severe adverse events
timeFrame: 12 weeks
measure: Acceptability, as measured by acceptability survey
timeFrame: 12 weeks
Other outcomes:
measure: Change in mobility as measured by Usual Gait Speed
timeFrame: Baseline, 12 weeks
measure: Change in balance as measured by Timed Up and Go
timeFrame: Baseline, 12 weeks
measure: Change in aerobic endurance as measured by Six-Minute Walk Test
timeFrame: Baseline, 12 weeks
measure: Change in upper body strength as measured by grip strength
timeFrame: Baseline, 12 weeks
measure: Change in lower body strength as measured by 30-second chair stand
timeFrame: Baseline, 12 weeks
measure: Change in quality of movement measured by functional movement screen
timeFrame: Baseline, 12 weeks
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Charity I Oyedeji, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
citation: 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.