Gerofit Exercise for Sickle Cell Disease

(SICKLE-FIT Trial)

Overseen By John J. Strouse, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Cognitive impairment, Wheelchair-bound, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a personalized exercise program can improve physical health and quality of life for adults with sickle cell disease (SCD), a condition affecting red blood cells. Participants will follow an exercise routine adapted from the Gerofit Exercise Program, conducted virtually three times a week for up to 12 weeks. The trial seeks individuals with any type of sickle cell disease who understand and speak English. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance daily living for those with SCD.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Gerofit Exercise Program is safe for adults with Sickle Cell Disease?

Research has shown that the Gerofit Exercise Program is safe for people with sickle cell disease (SCD). In past studies, participants, especially older adults with SCD, found the program enjoyable and safe. Most reported health issues were unrelated to the exercise program, indicating it is well-tolerated. The program also improves health, mental and physical abilities, and overall well-being. This provides a positive view of its safety for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Gerofit Exercise Program is unique because it brings a new approach to managing sickle cell disease by focusing on structured physical activity. Unlike standard treatments like hydroxyurea or blood transfusions, which aim to directly modify blood properties or manage symptoms, this program emphasizes regular exercise to potentially improve overall health and quality of life for patients. Researchers are excited about this trial because it explores the potential benefits of exercise in a virtual setting, offering a non-invasive and accessible way for participants to engage in health-promoting activities from the comfort of their homes.

What evidence suggests that the Gerofit Exercise Program is effective for improving physical health and quality of life in adults with Sickle Cell Disease?

Research has shown that the Gerofit Exercise Program, which participants in this trial will follow, can boost physical health and quality of life. In a study with older adults who had sickle cell disease, 93% of participants rated their exercise results as good or very good, and many expressed satisfaction with the program's effects. The program has also improved health, mental function, and well-being in other groups. This suggests that the Gerofit Exercise Program might effectively manage symptoms of sickle cell disease. ^{1 5 6 7 8}

Who Is on the Research Team?

Charity I Oyedeji, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults with Sickle Cell Disease (SCD) who can speak English fluently. Participants must have a confirmed diagnosis of any genotype of SCD. It's not suitable for those with unstable heart disease, severe cognitive issues, wheelchair users, oxygen-dependent individuals, or those who've had successful stem cell transplants for SCD.

Inclusion Criteria

I have been diagnosed with sickle cell disease through a specific blood test.

You are able to speak and understand English well.

Exclusion Criteria

You have a condition called avascular necrosis that is severe enough to require a medical device to assist you.

I have significant hearing or vision loss that hasn't been corrected.

I need oxygen support to breathe.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a personalized exercise program adapted from Gerofit, exercising 3 days a week for up to 12 weeks

12 weeks

Exercise sessions are virtual

Follow-up

Participants are monitored for safety and effectiveness after treatment, including Sickle Cell Disease Functional Assessment every 3 months

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Gerofit Exercise Program

Trial Overview The study is testing the Gerofit Exercise Program to see if it's safe and effective in improving physical health and quality of life in adults with SCD. The program will be personalized to each participant's abilities and needs.

How Is the Trial Designed?

Group I: Exercise Experimental Treatment 1 Intervention

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

Gerofit Exercise Program is already approved in United States for the following indications:

Approved in United States as Gerofit for:

• Improving physical health and quality of life in older adults
• Preventing mobility decline in older veterans

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

The Gerofit program, established in 1986 for older veterans, shows that a structured exercise and health promotion program can lead to significant functional improvements in older adults.

These benefits from the exercise program are not only immediate but can be maintained for up to 5 years, highlighting the long-term efficacy of regular physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Gerofit Program: a VA innovation. Morey, MC., Crowley, GM., Robbins, MS., et al.[2004]

Live video exercise groups for older adults showed improvements in physical function, with no significant differences compared to in-person sessions, based on a systematic review of nine studies involving participants aged 65 and older.

Participants in a case study reported similar attendance rates and benefits, such as improved balance, from both virtual and in-person sessions, suggesting that live video formats can be an effective alternative for exercise programs during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Function Effects of Live Video Group Exercise Interventions for Older Adults: A Systematic Review and Veteran's Gerofit Group Case Study. Fernandez, D., Wilkins, SS., Melrose, RJ., et al.[2023]

A telehealth exercise program is being tested for its feasibility and effectiveness in improving cardiorespiratory fitness among 80 older people with HIV, who are typically at risk for reduced fitness levels.

The program involves functional circuit training conducted via videoconferencing three times a week for 12 weeks, with heart rate monitoring to ensure participants maintain high exercise intensity, potentially addressing issues like sarcopenia and frailty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth Exercise Intervention in Older Adults With HIV: Protocol of a Multisite Randomized Trial. Oursler, KK., Marconi, VC., Briggs, BC., et al.[2023]

Exercise programs for elderly patients can significantly help in preventing illness and injury, as well as managing existing health conditions like cardiac and metabolic disorders.

The article emphasizes the importance of incorporating strength, endurance, balance, and flexibility into exercise training programs, along with recommendations for effective implementation and patient adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in the elderly: research and clinical practice. Frankel, JE., Bean, JF., Frontera, WR.[2006]

A systematic review of 24 studies involving 939 participants with sickle cell disease (SCD) found that maximal cardiopulmonary exercise testing (CPET) is generally safe, with only 3.8% reporting adverse events, primarily related to transient ECG changes or oxygen desaturation.

The low incidence of serious complications (only 0.43% experienced pain events) suggests that CPET can be effectively used to assess cardiopulmonary fitness and guide exercise recommendations for individuals with SCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of maximal cardiopulmonary exercise testing in individuals with sickle cell disease: a systematic review. Smith, KN., Baynard, T., Fischbach, PS., et al.[2022]

Sickle cell trait carriers may experience exercise-related complications due to various mechanisms, including changes in blood flow properties, inflammation, and oxidative stress.

Factors such as environmental conditions (like heat), hydration, fitness level, and exercise intensity can influence the risk of these complications during physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-related complications in sickle cell trait. Tripette, J., Hardy-Dessources, MD., Romana, M., et al.[2013]

There is a need for clear exercise guidelines for individuals with sickle cell trait (SCT) and sickle cell anemia (SCA) due to concerns about the risks of high-intensity exercise, which may lead to complications like pain and collapse.

Understanding the distinct issues and mechanisms that affect exercise-related risks in SCT and SCA is crucial for developing safe and effective exercise prescriptions, highlighting the importance of balancing the benefits of exercise against potential harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balancing exercise risk and benefits: lessons learned from sickle cell trait and sickle cell anemia. Liem, RI.[2019]

A multicenter study involving 40 patients with sickle-cell disease showed that a moderate-intensity endurance exercise program was safe and led to a significant improvement in functional capacity, with trained patients increasing their power output during exercise tests by 7.2 W compared to a decrease in the control group.

No serious adverse events occurred in the training group, while the control group experienced five adverse events, including vaso-occlusive crises, suggesting that exercise may reduce the risk of complications in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate-intensity endurance-exercise training in patients with sickle-cell disease without severe chronic complications (EXDRE): an open-label randomised controlled trial. Gellen, B., Messonnier, LA., Galactéros, F., et al.[2018]

Improving physical fitness through exercise significantly reduces the risk of death from all causes and cardiovascular disease in sedentary older adults, highlighting the importance of physical activity for longevity.

Exercise offers numerous benefits for the geriatric population, including improved body composition, increased strength, reduced depression and arthritis pain, and lower risks of diabetes and coronary artery disease, yet many healthcare professionals feel unprepared to create effective exercise programs for their patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and older patients: guidelines for the clinician. Christmas, C., Andersen, RA.[2022]

Regular exercise can help delay the onset of age-related conditions like coronary artery disease and type 2 diabetes, and it may also improve function and reduce disability in those already affected by these diseases.

For older adults, exercise programs should be adapted to include lower-intensity and low-impact activities, but there is a need for better strategies to motivate them to start and stick with these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for older patients with chronic disease. Petrella, RJ.[2010]

A 12-week home-based exercise program for 13 adolescents with sickle cell anemia showed high feasibility and safety, with 77% of participants completing 89% of the sessions without any exercise-related adverse events.

Although adherence to the exercise duration and target heart rate decreased in the second half of the study, the results suggest that regular exercise could be beneficial for children with sickle cell anemia, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and safety of home exercise training in children with sickle cell anemia. Liem, RI., Akinosun, M., Muntz, DS., et al.[2017]

The Gerofit exercise and health promotion program, involving 691 participants with significant baseline functional impairments, demonstrated long-lasting health benefits, including improved physical function maintained over 5 years and a 25% survival benefit over 10 years for participants.

High levels of participant satisfaction (88% to 94%) and statistically significant improvements in physical function at 3, 6, and 12 months (P < .05) suggest that structured exercise programs should be integrated into healthcare systems as essential services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should Structured Exercise Be Promoted As a Model of Care? Dissemination of the Department of Veterans Affairs Gerofit Program. Morey, MC., Lee, CC., Castle, S., et al.[2019]

The Gerofit facility-based exercise program successfully transitioned to a telehealth format during COVID-19, allowing 27% of participating Veterans to continue exercising remotely.

Remote physical performance testing indicated that participants were able to retain their physical function, suggesting that telehealth exercise programs can effectively mitigate health risks associated with decreased mobility in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Transition to Telehealth Group Exercise and Functional Assessments in Response to COVID-19. Jennings, SC., Manning, KM., Bettger, JP., et al.[2021]

Citations

1. va.gov va.gov/GERIATRICS/pages/gerofit_Home.asp

Geriatrics and Extended Care - Gerofit - A Program ... Participants in the program have demonstrated improved health, mental, physical function and well-being. Gerofit is a great way for Veterans to stay active by ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05714098/gerofit-exercise-intervention-for-older-adults-with-sickle-cell-disease-sickle-fit-study

Gerofit Exercise Intervention for Older Adults With Sickle ... 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).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11350545/

A qualitative study of the VA Gerofit exercise program We present the results by three key themes: Gerofit program features facilitating participation in regular exercise, the influence of self-efficacy on ...

4. researchgate.net researchgate.net/publication/386483186_The_Sicklefit_Exercise_Program_for_Older_Adults_with_Sickle_Cell_Disease_Feasibility_Acceptability_and_Safety

The Sicklefit Exercise Program for Older Adults with Sickle ... Most (93%) rated their exercise outcomes as good or very good, 7% rated outcomes as fair. Nearly all (93%) described being pleased or delighted ...

5. scholars.duke.edu scholars.duke.edu/person/miriam.morey/publications

Miriam C. Morey | Scholars@Duke profile: Publications ... Gerofit, an exercise and health promotion program for older veterans, was established. This paper describes the program in detail by summarizing the patient ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123119379

Personalized Exercise Intervention for Older Adults with ... In cohort 1, we found that the SickleFit exercise program is feasible, acceptable, and safe for older adults with SCD. Participants demonstrated improvements in ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124033512

The Sicklefit Exercise Program for Older Adults with Sickle ... This pilot study of SickleFit demonstrated it is safe and very enjoyable for older adults with SCD. Most AEs were unrelated to the exercise program.

8. reporter.nih.gov reporter.nih.gov/project-details/11059598

Project Details - NIH RePORTER Gerofit is a Veteran Health Administration health promotion program which has demonstrated significant gains in physical function, general well-being and other ...