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Exercise for Sickle Cell Trait

N/A

Recruiting

Led By Tim R Randolph, PhD

Research Sponsored by St. Louis University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Control group (AA): Healthy subjects without sickle cell trait (AA), Ages 18-70 years

Be older than 18 years old

Must not have

weigh less than 110 pounds

have hemoglobinopathies (other than sickle cell trait) as determined by Hb electrophoresis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how exercise affects people with sickle cell trait. It measures changes in the body before and after exercise to see how different biomarkers are affected. This could help explain why some people with sickle cell trait have complications after strenuous exercise.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves exercise as an intervention rather than medication, side effects may include typical exercise-related responses such as muscle soreness, fatigue, or shortness of breath.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I weigh less than 110 pounds.

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I have a blood disorder other than sickle cell trait.

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I am either a carrier of sickle cell trait (AS) or do not have sickle cell disease (AA).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in 11-dehydrothrombaxaneB2 (11-DTXB2) level

Change in C-reactive protein (CRP) level

Change in D-dimer level

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SCT GroupExperimental Treatment1 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 GroupActive Control1 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.

0 / 4Eligibility criteria met