Gerofit Exercise for Sickle Cell Disease
(SICKLE-FIT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Duke University
Disqualifiers: Cognitive impairment, Wheelchair-bound, Pregnancy, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345Is 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.
678910How 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.
13111213Eligibility 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.
+6 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: ExerciseExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke UniversityDurham, NC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
National Institutes of Health (NIH)Collaborator
References
The Gerofit Program: a VA innovation. [2004]In 1986 Gerofit, an exercise and health promotion program for older veterans, was established. This paper describes the program in detail by summarizing the patient assessment protocol, the exercise program, and program evaluation, as well as observational outcomes for up to 5 years of follow-up. Our data suggest that exercise provides older veterans with beneficial gains in function that are maintained for 5 years.
Exercise in the elderly: research and clinical practice. [2006]Exercise programs for elderly patients have received much attention recently for their potential role in preventing illness and injury, limiting functional loss and disability, and alleviating the course and symptoms of existing cardiac, pulmonary, and metabolic disorders. The basic components of an exercise training program include strength, endurance, balance, and flexibility. This article reviews the main attributes of each, along with some of the most recent research defining their roles in health care. Where available, it discusses specific recommendations for prescribing exercise modalities. Finally, it presents suggestions for developing integrated exercise programs and enhancing patient compliance.
Should Structured Exercise Be Promoted As a Model of Care? Dissemination of the Department of Veterans Affairs Gerofit Program. [2019]Exercise provides a wide range of health-promoting benefits, but support is limited for clinical programs that use exercise as a means of health promotion. This stands in contrast to restorative or rehabilitative exercise, which is considered an essential medical service. We propose that there is a place for ongoing, structured wellness and health promotion programs, with exercise as the primary therapeutic focus. Such programs have long-lasting health benefits, are easily implementable, and are associated with high levels of participant satisfaction. We describe the dissemination and implementation of a long-standing exercise and health promotion program, Gerofit, for which significant gains in physical function that have been maintained over 5 years of follow-up, improvements in well-being, and a 10-year 25% survival benefit among program adherents have been documented. The program has been replicated at 6 Veterans Affairs Medical Centers. The pooled characteristics of enrolled participants (n = 691) demonstrate substantial baseline functional impairment (usual gait speed 1.05 ± 0.3 m/s, 8-foot up and go 8.7 ± 6.7 seconds, 30-second chair stands 10.7 ± 5.1, 6-minute walk distance 404.31 ± 141.9 m), highlighting the need for such programs. Change scores over baseline for 3, 6, and 12 months of follow-up are clinically and statistically significant (P
Exercise and older patients: guidelines for the clinician. [2022]Sedentary persons who improve their physical fitness are less likely to die of all causes and of cardiovascular disease than are those who remain sedentary. There now exists a wealth of data demonstrating that physical activity and exercise may ameliorate disease and delay decline in function in the geriatric population. We review evidence that exercise can improve body composition, diminish falls, increase strength, reduce depression, reduce arthritis pain, reduce risks for diabetes and coronary artery disease, and improve longevity. However, many healthcare professionals do not feel adequately prepared to design and prescribe exercise programs for their patients. This review provides a basic overview of the benefits of exercise in the geriatric population and guidelines indicating how to prescribe and facilitate adherence to an exercise program. Healthcare providers are strongly encouraged to promote a less sedentary life style for their older patients, which may augment quality of life in these older individuals.
Exercise for older patients with chronic disease. [2010]Coronary artery disease, hypertension, congestive heart failure, type 2 diabetes mellitus, osteoarthritis, osteoporosis, and cognitive disorders become more prevalent as people age. Besides delaying the onset of many of these conditions, regular exercise may improve function and delay disability and morbidity in those who have them. Further, exercise may work synergistically with medication to combat the effects of some chronic diseases. Special adaptations for older patients include lower-intensity exercise (eg, fewer repetitions), low-impact exercise (cycling, exercise while sitting), and modified equipment (smaller weights, special shoes, loose clothing). Unresolved issues include development of optimal strategies for motivating older patients to begin and maintain exercise programs.
Safety of maximal cardiopulmonary exercise testing in individuals with sickle cell disease: a systematic review. [2022]We evaluated the safety of maximal cardiopulmonary exercise testing (CPET) in individuals with sickle cell disease (SCD). Maximal CPET using gas exchange analysis is the gold standard for measuring cardiopulmonary fitness in the laboratory, yet its safety in the SCD population is unclear.
Exercise-related complications in sickle cell trait. [2013]This review presents the epidemiological data regarding the exercise-related complication in exercising sickle cell trait carriers, and focuses on the different potential mechanisms that could be involved in these adverse events, such as hemorheological alterations, inflammation, vascular adhesion of circulating blood cells, oxidative stress and impaired nitric oxide metabolism. We also discuss the effects of different modulating factors such as vascular function, environment (hot temperature), hydration status, physical fitness, exercise intensity and genetic factors.
Balancing exercise risk and benefits: lessons learned from sickle cell trait and sickle cell anemia. [2019]Development of exercise guidelines for individuals with sickle cell trait (SCT) and sickle cell anemia (SCA) is hampered by the need to weigh the benefits against risks of exercise in these populations. In SCT, concern for exercise collapse associated with sickle cell trait has resulted in controversial screening of student athletes for SCT. In SCA, there exists unsubstantiated concerns that high-intensity exercise may result in pain and other complications. In both, finding the "right dose" of exercise remains a challenge for patients and their providers. Despite assumptions that factors predisposing to adverse events from high-intensity exercise overlap in SCT and SCA, the issues that frame our understanding of exercise-related harms in both are distinct. This review will compare issues that affect the risk-benefit balance of exercise in SCT and SCA through these key questions: (1) What is the evidence that high-intensity exercise is associated with harm? (2) What are the pathophysiologic mechanisms that could predispose to harm? (3) What are the preventive strategies that may reduce risk? and (4) Why do we need to consider the benefits of exercise in this debate? Addressing these knowledge gaps is essential for developing an evidence-based exercise prescription for these patient populations.
Feasibility and safety of home exercise training in children with sickle cell anemia. [2017]Exercise guidelines do not exist for individuals with sickle cell anemia (SCA) despite the impact of disease-related complications on physical functioning. Thirteen subjects (mean 15.1 ± 2.8 years old) with SCA were prescribed three exercise sessions/week for 12 weeks on a stationary bicycle placed at home. In total, 77% of subjects completed 89% of prescribed sessions without exercise-related adverse events, thus meeting feasibility and safety criteria. Adherence to prescribed duration and target heart rate during training decreased during the second half of the study. Future trials are warranted to further evaluate training benefits associated with regular exercise in children with SCA.
Moderate-intensity endurance-exercise training in patients with sickle-cell disease without severe chronic complications (EXDRE): an open-label randomised controlled trial. [2018]Exercise could be a triggering factor for vaso-occlusive crises in patients with sickle-cell disease. We aimed to investigate whether a patient-adapted training programme of moderate endurance exercise could be safe and beneficial for patients with sickle-cell disease.
Rapid Transition to Telehealth Group Exercise and Functional Assessments in Response to COVID-19. [2021]Exercise is critical for health maintenance in late life. The COVID-19 shelter in place and social distancing orders resulted in wide-scale interruptions of exercise therapies, placing older adults at risk for the consequences of decreased mobilization. The purpose of this paper is to describe rapid transition of the Gerofit facility-based group exercise program to telehealth delivery. This Gerofit-to-Home (GTH) program continued with group-based synchronous exercise classes that ranged from 1 to 24 Veterans per class and 1 to 9 classes offered per week in the different locations. Three hundred and eight of 1149 (27%) Veterans active in the Gerofit facility-based programs made the transition to the telehealth delivered classes. Participants' physical performance testing continued remotely as scheduled with comparisons between most recent facility-based and remote testing suggesting that participants retained physical function. Detailed protocols for remote physical performance testing and sample exercise routines are described. Translation to remote delivery of exercise programs for older adults could mitigate negative health effects.
Physical Function Effects of Live Video Group Exercise Interventions for Older Adults: A Systematic Review and Veteran's Gerofit Group Case Study. [2023]Background: Literature on telehealth interventions for older adults has been primarily on asynchronous interventions. During the COVID-19 pandemic, older adult exercise programs transitioned to an online format. This systematic review and case study examines the effectiveness of older adult live video exercise group interventions on physical health with insights from a Los Angeles VA program, Gerofit. Methods: PubMed was searched for live video older adult exercise groups from database inception to November 2021. All eligible studies included assessments of physical health and were limited to participants with an average age of 65 years or greater. Ten Veterans, who had participated in both in-person and virtual Gerofit sessions, were surveyed in the case study. Results: Nine studies met the inclusion criteria. Four studies included an equivalent in-person group as a comparator to the live video group and reported no significant between-group differences in outcomes, including energy expenditure and 6-minute walking distance test (6MWD). The other five studies reported statistically significant in-group improvement in outcomes including isokinetic knee strength. Case study participants reported similar attendance rates and perceived benefits, such as improved balance, when comparing virtual and in-person sessions. Discussion: Live video exercise groups in older adults demonstrated an improvement in physical function that was not statistically different from the comparison in-person sessions with the added benefit of averaging a higher attendance rate, providing initial support for the use of live video in older adult exercise programs. Insights from the case study supplement this by demonstrating older adults' positive attitude on these groups.
Telehealth Exercise Intervention in Older Adults With HIV: Protocol of a Multisite Randomized Trial. [2023]People with HIV (PWH) have reduced cardiorespiratory fitness, but a high intensity, easily disseminated exercise program has not yet been successfully developed in older PWH. The purpose of this article is to describe a synchronous telehealth exercise intervention in older PWH, delivered from one medical center to two other centers. Eighty older PWH (≥50 years) on antiretroviral therapy will be randomized to exercise or delayed entry control groups. Functional circuit exercise training, which does not entail stationary equipment, will be provided by real-time videoconferencing, 3 times weekly for 12 weeks, to small groups. Continuous remote telemonitoring of heart rate will ensure high exercise intensity. We hypothesize that telehealth exercise will be feasible and increase cardiorespiratory fitness and reduce sarcopenia and frailty. Findings will provide new insight to target successful aging in older PWH and can also be widely disseminated to PWH of any age or other patient populations.