Exercise for Sickle Cell Trait

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

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study measures the effect of exercise on a variety of biomarkers in blood and urine selected to evaluate the physiological pathways of hemolysis, myolysis, thrombosis, inflammation, and renal function in subjects with sickle cell trait. These pathways have been shown to be associated with adverse events in athletes and warfighters with SCT upon protracted, repeated, strenuous exertion. Changes in biomarkers post-exercise compared to pre-exercise (and compared to healthy controls) suggest activation of the associated pathway(s) which may contribute to exercise-related events in athletes and warfighters and subclinical complications in non-athletes.

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+