Sickle Cell DiseaseSICKLE-FITNCT05714098
Gerofit Exercise Intervention for Older Adults With Sickle Cell Disease (SICKLE-FIT Study)
A study testing Gerofit Exercise Program in people with Sickle Cell Disease, run by Duke University at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Gerofit Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to 8 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of sickle cell disease (any genotype) confirmed by hemoglobin electrophoresis, high performance liquid chromatography, or genotyping
- Understand and speak fluent English.
Who cannot join
- 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
Show all 9Show fewer
- Pregnant
- Have severe avascular necrosis requiring an assist device
- Unstable cardiac disease.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Gerofit Exercise Program
- Keywords
- sickle cell anemia, older adults, exercise, geriatrics, functional impairment
- Medical subject headings
- Anemia, Sickle Cell, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gerofit Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual Receives: Behavioral: Gerofit Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, as Measured by Number of Participants Completing at Least 50% of the Exercise Sessions
Measured: 12 weeks
Secondary outcomes (2)
Safety, as Measured by Number of Participants With Moderate or Severe Adverse Events
Number of participants with one or more moderate or severe adverse events within 48 hours after each exercise session.
Measured: 12 weeks
Acceptability, as Measured by the Number of Participants Reporting the Intervention as Acceptable
Acceptability of the exercise program was measured on a scale of 1-10, where 1= severe dislike and 10 = absolute enjoyment. Reported as the number of participants with scores of 8-10.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start27 Mar 2023
- Primary completion30 May 2025
- Study completion8 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Charity I Oyedeji, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714098
- Sponsor's protocol ID
- Pro00111833
- Acronym
- SICKLE-FIT
- Status last verified
- Jun 2026
- First submitted
- 18 Jan 2023
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29430642Oyedeji 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.
PubMed 35246265Morey 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.
PubMed 12473002Morey 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.
PubMed 2921457Oyedeji 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.
PubMed 30663090Liem 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.
PubMed 30504341Merlet 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.
PubMed 31742587Liem 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.
PubMed 28598539Callaway T, Mohamed RE, Poole T, Lin L, Oliva FD, Faldowski R, Vessels C, Manning K, Jennings S, Mason T, Cohen HJ, Pieper CF, Hall KS, Morey MC, Strouse JJ, Oyedeji CI. The SickleFit Tele-Exercise Program for older adults with sickle cell disease: feasibility, acceptability, safety study. Blood Red Cells Iron. 2026 Aug 25:100124. doi: 10.1016/j.brci.2026.100124. Online ahead of print.
PubMed 42836085
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gerofit Exercise Intervention for Older Adults With Sickle Cell Disease (SICKLE-FIT Study)
- ClinicalTrials.gov ID
- NCT05714098
- Acronym / sponsor ID
- SICKLE-FIT / Pro00111833
- Conditions
- Sickle Cell Disease
- Keywords
- sickle cell anemia, older adults, exercise, geriatrics, functional impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 8 Aug 2025 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Gerofit Exercise ProgramEach cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a diagnosis of sickle cell disease (any genotype) confirmed by hemoglobin electrophoresis, high performance liquid chromatography, or genotyping
- Understand and speak fluent English.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gerofit Exercise ProgramThe 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. | Behavioural | Exercise |
Primary outcome
Feasibility, as Measured by Number of Participants Completing at Least 50% of the Exercise Sessions
Time frame: 12 weeks
2 secondary outcomes
Safety, as Measured by Number of Participants With Moderate or Severe Adverse Events
Time frame: 12 weeks
Acceptability, as Measured by the Number of Participants Reporting the Intervention as Acceptable
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29430642Morey 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.
- Background: PubMed 35246265Oyedeji 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.
- Background: PubMed 12473002Morey 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.
- Background: PubMed 2921457Morey 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.
- Background: PubMed 30663090Oyedeji 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.
- Background: PubMed 30504341Liem 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.
- Background: PubMed 31742587Merlet 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.
- Background: PubMed 28598539Liem 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.
- Derived from this study: PubMed 42836085Callaway T, Mohamed RE, Poole T, Lin L, Oliva FD, Faldowski R, Vessels C, Manning K, Jennings S, Mason T, Cohen HJ, Pieper CF, Hall KS, Morey MC, Strouse JJ, Oyedeji CI. The SickleFit Tele-Exercise Program for older adults with sickle cell disease: feasibility, acceptability, safety study. Blood Red Cells Iron. 2026 Aug 25:100124. doi: 10.1016/j.brci.2026.100124. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charity I Oyedeji, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gerofit Exercise Program in people with Sickle Cell Disease, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, as Measured by Number of Participants Completing at Least 50% of the Exercise Sessions (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05714098, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.