Exercise for Sickle Cell Anemia

Overseen By Cynthia W Karlson, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Mississippi Medical Center

Disqualifiers: Non-English, Cognitive impairment, Hypertension, others

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

Compensation: Varies

Number of Visits: 27

60 Participants Needed

Trial Summary

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 for sickle cell anemia?

Research shows that moderate-intensity endurance training can improve muscle function and quality of life in sickle cell disease patients. Additionally, physical exercise has been found to enhance ventilatory efficiency and reduce stress markers in sickle cell anemia patients, suggesting potential health benefits. ^{1 2 3 4 5}

Is exercise safe for people with sickle cell anemia?

Research shows that moderate exercise, like home-based training, is generally safe for people with sickle cell anemia, with most participants completing sessions without any exercise-related problems. ^{2 3 6 7 8}

How does the treatment of exercise for sickle cell anemia differ from other treatments?

This treatment is unique because it involves low to moderate intensity exercise, which can improve physical functioning and quality of life without the need for medication. Unlike traditional treatments that focus on managing symptoms with drugs, this approach uses exercise to enhance respiratory muscle strength, reduce inflammation, and improve blood flow, making it a novel non-drug option for managing sickle cell anemia. ^{1 2 3 5 8}

What is the purpose of this trial?

This research study wants to learn about what kind of exercise is best for kids with sickle cell disease. Participating children will have a small amount of blood drawn one time at the beginning of the study. Children will then complete some questionnaires that measure pain, physical function, and emotions (depression, anxiety) and complete some tests that measure physical fitness at the beginning and end of the study. Children will be randomized to either a home-based telehealth (1) walking or (2) strengthening exercise program that lasts for 8-weeks, 3-x week, for 45 minutes each session. Children's participation will last up to 10 weeks.

Research Team

Yolanda Griffin

Principal Investigator

Director-Clinical Trials Office

Eligibility Criteria

This trial is for children with sickle cell disease. They'll need to have a small blood sample taken, fill out questionnaires on pain, physical function, and emotions, and do fitness tests at the start and end of the study. The exercise program will be done at home via telehealth.

Inclusion Criteria

Has daily access to an Internet-enabled device (e.g., smartphone, iPad)

I am over 21 and will participate with my child in this study.

I am between 12 and 17 years old.

Exclusion Criteria

Non-English speaking due to lack of available written translation services for informed consent and questionnaires

I do not have a cognitive condition that stops me from completing the study.

I have been cleared by Dr. McNaull to safely complete exercises.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline Research Visit

Baseline assessments including questionnaires, blood draw, and physical fitness assessment

1 day

1 visit (in-person)

Instructional Exercise Session

Participants perform one 45-minute exercise session in-person and receive education on safe exercise

1 day

1 visit (in-person)

3-day Ambulatory Monitoring

Participants undergo 3 consecutive days of actigraphy ambulatory monitoring and pain diary completion

3 days

8-Week Telehealth Exercise Protocol

Participants complete 8 weeks of home-based telehealth exercise sessions, supervised via Telehealth

8 weeks

24 sessions (virtual)

Follow-up Visit

Participants return for follow-up assessments including questionnaires and physical fitness evaluation

1 day

1 visit (in-person)

Treatment Details

Interventions

• Low systemic strength training
• Moderate systemic exercise

Trial Overview The study is testing two types of exercise programs over 8 weeks: one focuses on walking while the other emphasizes strength training. Kids will do these exercises three times a week for about 45 minutes each session to see which type is best for managing their condition.

Participant Groups

Group I: Moderate systemic exercise Experimental Treatment 1 Intervention

8-week (3 times per week; 45-minute sessions) home-based telehealth walking protocol

Group II: Low systemic strength training Experimental Treatment 1 Intervention

8-week (3 times per week; 45-minute sessions) home-based telehealth strengthening exercise program

Who Is Running the Clinical Trial?

University of Mississippi Medical Center

Lead Sponsor

Trials

185

Recruited

200,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Findings from Research

A study involving 60 asymptomatic sickle cell anemia patients showed that 12 weeks of aerobic exercise training significantly reduced inflammatory markers (like IL-6 and TNF-α) and improved immune parameters (CD3, CD4, and CD8 counts).

In contrast, the control group that did not participate in exercise training showed no significant changes in these immunologic parameters, highlighting the potential benefits of aerobic exercise for managing inflammation in sickle cell anemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of aerobic exercises on selected inflammatory markers and immune system response among patients with sickle cell anemia in asymptomatic steady state. Abd El-Kader, SM., Al-Shreef, FM.[2022]

Inspiratory muscle training (IMT) significantly improved respiratory muscle strength, functional exercise capacity, and quality of life in a 32-year-old patient with sickle cell anemia suffering from recurrent acute chest syndrome, as measured by various standardized tests.

After starting regular erythrocytapheresis and IMT, the patient did not experience any emergency department admissions for acute chest syndrome over the following 12 months, indicating a potential long-term benefit of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Inspiratory Muscle Training in Sickle Cell Anemia Related Pulmonary Damage due to Recurrent Acute Chest Syndrome Attacks. Camcıoğlu, B., Boşnak-Güçlü, M., Karadallı, MN., et al.[2020]

Inspiratory muscle training (IMT) significantly improved respiratory muscle strength, lung function, and exercise tolerance in adults with sickle cell anemia, regardless of whether they received true or sham training, indicating a potential benefit of IMT for this patient group.

After 18 weeks of home-based IMT, both groups experienced reductions in dyspnea during daily activities and improvements in fatigue impact, suggesting that IMT can enhance quality of life for individuals with sickle cell anemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of home-based inspiratory muscle training on sickle cell disease (SCD) patients. Galvão, F., Zanoni, CT., Moreira, MM., et al.[2021]

A moderate-intensity endurance training program significantly improved skeletal muscle structural and metabolic properties in 33 patients with sickle cell disease, including increased type I muscle fiber surface area and enhanced oxidative enzyme activity.

The training led to better exercise capacity, as evidenced by lower respiratory frequency and perceived exertion at submaximal power outputs, indicating improved overall muscle function and quality of life for the patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Muscle structural, energetic and functional benefits of endurance exercise training in sickle cell disease. Merlet, AN., Féasson, L., Bartolucci, P., et al.[2020]

A six-week exercise program for 12 patients with sickle cell anemia improved several health markers, including ventilatory efficiency and reduced levels of harmful nitrosative stress and free hemoglobin, indicating better nitric oxide availability.

Despite no significant changes in exercise performance or hematological profiles, the study suggests that even low-intensity physical activity can enhance the overall health and daily activity levels of SCA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of A Six Week Training Program on Ventilatory Efficiency, Red Blood Cell Rheological Parameters and Red Blood Cell Nitric Oxide Signaling in Young Sickle Cell Anemia Patients: A Pilot Study. Grau, M., Nader, E., Jerke, M., et al.[2020]

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]

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]

References

1. Uganda pubmed.ncbi.nlm.nih.gov

Impact of aerobic exercises on selected inflammatory markers and immune system response among patients with sickle cell anemia in asymptomatic steady state. [2022]

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

The Role of Inspiratory Muscle Training in Sickle Cell Anemia Related Pulmonary Damage due to Recurrent Acute Chest Syndrome Attacks. [2020]

3. Brazil pubmed.ncbi.nlm.nih.gov

Effects of home-based inspiratory muscle training on sickle cell disease (SCD) patients. [2021]

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

Muscle structural, energetic and functional benefits of endurance exercise training in sickle cell disease. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of A Six Week Training Program on Ventilatory Efficiency, Red Blood Cell Rheological Parameters and Red Blood Cell Nitric Oxide Signaling in Young Sickle Cell Anemia Patients: A Pilot Study. [2020]

6. 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]

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

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

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

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