12 Participants Needed

Exercise for Sickle Cell Trait

TR
KN
Overseen ByKitty Newsham, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: St. Louis University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

TR

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
See 3 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: SCT GroupExperimental Treatment1 Intervention
Group II: Control GroupActive Control1 Intervention

Find a Clinic Near You

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+
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