Exercise for Sickle Cell Trait

No longer recruiting at 1 trial location

Overseen By Kitty Newsham, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Louis University

Disqualifiers: Pregnancy, Hemoglobinopathies, Renal disease, 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: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how exercise affects individuals with sickle cell trait, focusing on changes in blood and urine markers related to blood breakdown, muscle damage, clotting, inflammation, and kidney function. Understanding these risks is crucial during intense physical activities, such as sports or military training. Participants will include individuals with sickle cell trait and healthy individuals, both engaging in a controlled treadmill exercise session. Ideal candidates have sickle cell trait, maintain good health, and frequently face physical activity challenges. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance safety guidelines for physical activities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that exercise is safe for individuals with sickle cell trait?

Research shows that exercise, when done carefully, is safe for people with sickle cell disease. Studies indicate that light to moderate exercise doesn't cause major issues for these individuals and might even benefit their health. Additionally, new research suggests that people with sickle cell trait are not at a higher risk of heart problems compared to those without the trait. This supports the idea that exercise is generally safe for them too. Overall, evidence suggests that exercise is a safe option for those with sickle cell trait. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how exercise might uniquely benefit individuals with sickle cell trait (SCT). Unlike medication-based treatments, which often focus on managing symptoms or complications, this approach investigates whether a simple, non-invasive exercise regimen can safely enhance cardiovascular health in SCT carriers. By understanding the effects of exercise on those with SCT, researchers aim to uncover new insights that could lead to lifestyle recommendations, potentially offering a natural and accessible way to improve health outcomes for individuals with this genetic trait.

What evidence suggests that exercise is effective for individuals with sickle cell trait?

Studies have shown that exercise can benefit people with sickle cell disease. Light to moderate exercise is usually safe and might enhance fitness and quality of life. Research suggests that exercise can also help manage some symptoms by improving blood flow and reducing pain episodes. While this research mainly focuses on sickle cell disease, it offers promising insights into how exercise could also benefit those with sickle cell trait. In this trial, participants in the SCT Group will undergo a standardized exercise session to explore these potential benefits. However, exercise routines must be planned carefully to avoid risks associated with intense activity. ^{1 2 3 6 7}

Who Is on the Research Team?

Tim R Randolph, PhD

Principal Investigator

St. Louis University

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-70, with or without sickle cell trait (SCT). It's not for those under 110 pounds, pregnant women, people with other hemoglobin disorders besides SCT, or anyone with conditions that make exercise risky.

Inclusion Criteria

I am healthy, aged 18-70, and do not have the sickle cell trait.

I am between 18 and 70 years old with sickle cell trait.

Exclusion Criteria

You have a medical condition that could make it dangerous for you to participate in physical activity.

I have conditions that affect blood clotting, muscle breakdown, chronic inflammation, or kidney function.

are pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Session

Participants undergo a single bout of standardized exercise on a treadmill

1 day

1 visit (in-person)

Biomarker Assessment

Blood and urine samples are collected before exercise, immediately after exercise, and 24 hours after exercise to measure changes in biomarkers

1 day

3 sample collections (in-person)

Follow-up

Participants are monitored for safety and effectiveness after exercise

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview The study looks at how exercise affects certain biomarkers in the blood and urine of people with SCT. These markers help understand risks during intense activities. Participants' results will be compared before and after exercising and to those without SCT.

How Is the Trial Designed?

Group I: SCT Group Experimental Treatment 1 Intervention

Fifteen SCT subjects will be recruited, consented, screened, and enrolled if they meet inclusion and exclusion criteria. Each subject will undergo a single bout of standardized exercise on a treadmill. Subjects will self-select treadmill speed at 0% grade and begin. After 3 minutes the grade will be increased by 1% every 2 minutes until the target heart rate (70% of heart rate reserve) is reached. Speed and grade will be held constant for 15 minutes, marking the end of the session.

Group II: Control Group Active Control 1 Intervention

Five healthy subjects will be recruited, consented, screened, and enrolled if they meet inclusion and exclusion criteria. Each subject will undergo a single bout of standardized exercise on a treadmill. Subjects will self-select treadmill speed at 0% grade and begin. After 3 minutes the grade will be increased by 1% every 2 minutes until the target heart rate (70% of heart rate reserve) is reached. Speed and grade will be held constant for 15 minutes, marking the end of the session.

Who Is Running the Clinical Trial?

St. Louis University

Lead Sponsor

Trials

197

Recruited

41,400+

American Society for Clinical Laboratory Science

Collaborator

Trials

1

Recruited

10+

Citations

1. hematologyadvisor.com hematologyadvisor.com/features/sickle-cell-disease-and-exercise-training/

Sickle Cell Disease and Exercise Training: Friend or Foe? Researchers discovered mild-to-moderate exercise training is safe for patients with SCD and could be a beneficial therapeutic adjunct.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6245992/

Balancing exercise risk and benefits: lessons learned from ... In another study, 83% of adults with sickle cell disease (all genotypes) had evidence for decreased maximal exercise capacity. Besides maximal cardiopulmonary ...

3. link.springer.com link.springer.com/article/10.1007/s44337-024-00047-1

The role of exercise in sickle cell anemia management The findings show the potential benefits of exercise in enhancing physical fitness and quality of life in adults with SCA. Structured exercise ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0006497121050369

Quantitative Assessment of Physical Activity in Adults with ... The objective of this study is to determine physical activity levels in addition to identifying barriers, facilitators, and attitudes towards physical activity.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ajh.27454

Exercise and training in sickle cell disease This review aims to elucidate the safety, potential benefits, and recommendations regarding exercise and training in individuals with SCD.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06823219

Long-term Endurance Training in Sickle Cell Disease ... Exercise limitations in SCD are related to anaemia, as walking for 5 minutes at 5 km/h leads to large elevations in heart rate (~175 beats/min) ...

7. hematology.org hematology.org/newsroom/press-releases/2016/studies-challenge-assumptions-about-sickle-cell-trait-and-cardiovascular-health

Studies Challenge Assumptions About Sickle Cell Trait and ... New data suggest sickle cell trait is not associated with heart failure or diminished fitness recovery.