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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
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

Study 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.Check my eligibility
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.See study design
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
Select...
I am healthy, aged 18-70, and do not have the sickle cell trait.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in 11-dehydrothrombaxaneB2 (11-DTXB2) level
Change in C-reactive protein (CRP) level
Change in D-dimer level
+12 more

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.

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Who is running the clinical trial?

St. Louis UniversityLead Sponsor
194 Previous Clinical Trials
43,635 Total Patients Enrolled
American Society for Clinical Laboratory ScienceUNKNOWN
Tim R Randolph, PhDPrincipal InvestigatorSt. Louis University

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT04273022 — N/A
Sickle Cell Trait Research Study Groups: SCT Group, Control Group
Sickle Cell Trait Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT04273022 — N/A
Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT04273022 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Dec 2024