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

Trial Summary

What is the purpose of this trial?

This trial is testing a personalized exercise program for adults aged 40 and older with sickle cell disease. The goal is to see if this exercise plan can improve their physical health and quality of life. Participants will be monitored regularly to track their progress and provide feedback on the program. Exercise programs have been studied as a potential therapeutic strategy for patients with sickle cell disease, showing benefits in functional capacity and cardiovascular health.

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 data supports the effectiveness of the treatment Gerofit Exercise Program for Sickle Cell Disease?

The Gerofit Exercise Program has shown significant health benefits for older veterans, including improved physical function, well-being, and a 25% survival benefit over 10 years. These benefits suggest that structured exercise programs like Gerofit can provide long-lasting health improvements, which may also be beneficial for individuals with chronic conditions such as Sickle Cell Disease. ^{1 2 3 4 5}

Is the Gerofit Exercise Program safe for people with sickle cell disease?

Research shows that moderate exercise can be safe for people with sickle cell disease, as studies found no exercise-related adverse events in children and suggest that patient-adapted exercise programs can be safe. However, high-intensity exercise may pose risks, so it's important to follow tailored exercise guidelines. ^{6 7 8 9 10}

How is the Gerofit Exercise Program treatment different from other treatments for sickle cell disease?

The Gerofit Exercise Program is unique because it focuses on structured exercise as a primary therapeutic approach, promoting long-term health benefits and improved physical function, which is different from traditional medical treatments for sickle cell disease that often focus on medication and pain management. ^{1 3 11 12 13}

Research Team

Charity I Oyedeji, MD

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Gerofit Program: a VA innovation. [2004]

2. United States pubmed.ncbi.nlm.nih.gov

Exercise in the elderly: research and clinical practice. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Should Structured Exercise Be Promoted As a Model of Care? Dissemination of the Department of Veterans Affairs Gerofit Program. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Exercise and older patients: guidelines for the clinician. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Exercise for older patients with chronic disease. [2010]

6. England pubmed.ncbi.nlm.nih.gov

Safety of maximal cardiopulmonary exercise testing in individuals with sickle cell disease: a systematic review. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise-related complications in sickle cell trait. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Feasibility and safety of home exercise training in children with sickle cell anemia. [2017]

10. England 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. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Rapid Transition to Telehealth Group Exercise and Functional Assessments in Response to COVID-19. [2021]

12. United States 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. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Telehealth Exercise Intervention in Older Adults With HIV: Protocol of a Multisite Randomized Trial. [2023]