60 Participants Needed

Exercise for Sickle Cell Anemia

RA
CW
Overseen ByCynthia W Karlson, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Mississippi Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which type of exercise benefits children with sickle cell disease the most. Researchers will assign participants to either a home-based telehealth walking program (moderate systemic exercise) or a strengthening exercise program (low systemic strength training) for eight weeks. The study seeks children aged 12 to 17 who have a specific type of sickle cell disease and internet access at home. Participants will complete questionnaires about pain and emotions and undergo physical tests. As an unphased trial, this study provides a unique opportunity for children to contribute to research that could enhance exercise recommendations for sickle cell disease.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that low-to-moderate intensity exercise is generally safe for people with sickle cell disease (SCD). Studies indicate that gentle strength training and moderate exercise, such as walking, are well-tolerated by those with sickle cell anemia and usually do not lead to severe side effects like vaso-occlusive crises, which are painful blockages in blood flow.

Evidence suggests that gentle strength training can be performed without causing significant problems. Similarly, moderate exercise has been shown to be safe for people with sickle cell disease, even for those without severe long-term issues. This type of exercise can help manage SCD by improving overall fitness and quality of life.

Overall, both exercise programs appear safe for children with sickle cell disease, with no major harmful effects reported in previous studies.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for sickle cell anemia because they offer a non-pharmaceutical approach to managing the condition. Unlike standard treatments that often involve medications like hydroxyurea or blood transfusions, these exercise programs focus on physical activity through home-based telehealth sessions. The low systemic strength training and moderate systemic exercise protocols are unique because they aim to improve overall health and potentially alleviate symptoms through regular, guided physical activity. This approach could empower patients to take an active role in their care while minimizing reliance on medication.

What evidence suggests that this trial's exercise programs could be effective for sickle cell disease?

Research has shown that both light strength training and moderate exercise can benefit children with sickle cell disease. In this trial, participants will join one of two exercise programs. One group will engage in low systemic strength training, which studies indicate can reduce pain and strengthen muscles when performed at home. Another group will participate in moderate systemic exercise, which research has found to be safe for individuals with sickle cell disease and can enhance heart and blood vessel health. Additionally, endurance training, a component of moderate exercise, can improve the body's oxygen use and aid in recovery. These findings suggest that exercise, whether strength training or moderate activity, could be a valuable part of managing sickle cell disease.26789

Who Is on the Research Team?

YG

Yolanda Griffin

Principal Investigator

Director-Clinical Trials Office

Are You a Good Fit for This Trial?

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.
See 1 more

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Moderate systemic exerciseExperimental Treatment1 Intervention
Group II: Low systemic strength trainingExperimental Treatment1 Intervention

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
Effects of home-based inspiratory muscle training on sickle cell disease (SCD) patients.Galvão, F., Zanoni, CT., Moreira, MM., et al.[2021]
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.
Feasibility and safety of home exercise training in children with sickle cell anemia.Liem, RI., Akinosun, M., Muntz, DS., et al.[2017]
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.
Balancing exercise risk and benefits: lessons learned from sickle cell trait and sickle cell anemia.Liem, RI.[2019]

Citations

Effectiveness of a home-based therapeutic exercise program ...Results suggest that daily home-based exercises for a three-month period ameliorate pain and improve disability related to lower back pain and muscle strength.
Exercise for Sickle Cell Anemia... Low systemic strength training and Moderate systemic exercise will have tolerable side effects & efficacy for patients with Sickle Cell Disease. See if you ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/32680757/
Effectiveness of a home-based therapeutic exercise ...Results suggest that daily home-based exercises for a three-month period ameliorate pain and improve disability related to lower back pain and muscle strength.
Low Systemic/High Local Exercise Load in Peds SCDTesting the Effects of Home-Based Exercise Programs on Pain and Fitness in Children with Sickle Cell Disease. Check your eligibility. Share study information
Cardiovascular benefits of a home-based exercise program in ...The selected home-based exercise program is safe, feasible, and promotes a favorable impact on functional capacity and cardiovascular function in sickle cell ...
Low Systemic/High Local Exercise Load in Peds SCDStudy Overview. Brief Summary. This research study wants to learn about what kind of exercise is best for kids with sickle cell disease.
Balancing exercise risk and benefits: lessons learned from ...This review will compare issues that affect the risk-benefit balance of exercise in SCT and SCA through these key questions.
Exercise and training in sickle cell diseaseThis review aims to elucidate the safety, potential benefits, and recommendations regarding exercise and training in individuals with SCD.
Physical exercise in sickle cell anemia: a systematic reviewLow-to-moderate intensity physical exercise increased the SCA individual tolerance without causing vaso-occlusive crises, nor changes in the hemorheological ...
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