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

Primary Purpose

Sickle Cell Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Gerofit Exercise Program

About this trial

This is an interventional treatment trial for Sickle Cell Disease focused on measuring sickle cell anemia, older adults, exercise, geriatrics, functional impairment

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Duke UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise

Arm Description

Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Acceptability, as measured by acceptability survey

Number of participants reporting the intervention as acceptable

Full Information

NCT ID

NCT05714098

First Posted

January 18, 2023

Last Updated

April 19, 2023

Sponsor

Duke University

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT05714098

Brief Title

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

Acronym

SICKLE-FIT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 27, 2023 (Actual)

Primary Completion Date

December 30, 2027 (Anticipated)

Study Completion Date

December 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sickle Cell Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exercise

Arm Type

Experimental

Arm Description

Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual

Intervention Type

Behavioral

Intervention Name(s)

Gerofit Exercise Program

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Description

Number of participants with 1 or more moderate or severe adverse events within 48 hours after each exercise session

Time Frame

12 weeks

Title

Acceptability, as measured by acceptability survey

Description

Number of participants reporting the intervention as acceptable

Time Frame

12 weeks

Other Pre-specified Outcome Measures:

Title

Change in mobility as measured by Usual Gait Speed

Time Frame

Baseline, 12 weeks

Title

Change in balance as measured by Timed Up and Go

Time Frame

Baseline, 12 weeks

Title

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

Time Frame

Baseline, 12 weeks

Title

Change in upper body strength as measured by grip strength

Time Frame

Baseline, 12 weeks

Title

Change in lower body strength as measured by 30-second chair stand

Time Frame

Baseline, 12 weeks

Title

Change in quality of movement measured by functional movement screen

Time Frame

Baseline, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Charity I Oyedeji, MD

Phone

9196840628

charity.oyedeji@duke.edu

First Name & Middle Initial & Last Name or Official Title & Degree

John J. Strouse, MD, PhD

Phone

9196840628

john.strouse@duke.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charity I Oyedeji, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Charity I Oyedeji, MD

Phone

919-684-0628

charity.oyedeji@duke.edu

First Name & Middle Initial & Last Name & Degree

John J Strouse, MD, PhD

Phone

919684-0628

john.strouse@duke.edu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29430642

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.

Results Reference

background

PubMed Identifier

35246265

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.

Results Reference

background

PubMed Identifier

12473002

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.

Results Reference

background

PubMed Identifier

2921457

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.

Results Reference

background

PubMed Identifier

30663090

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.

Results Reference

background

PubMed Identifier

30504341

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.

Results Reference

background

PubMed Identifier

31742587

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.

Results Reference

background

PubMed Identifier

28598539

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.

Results Reference

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

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