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Graded Exercise for Acute Phase Response

N/A

Waitlist Available

Led By Jonathan Schoenecker, MD, PhD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to post-exercise/marathon (within 3 hours of exercise/marathon completion)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effects of different types of exercise on the APR in healthy individuals.

Who is the study for?

This trial is for healthy individuals aged 18-29 or 18-49, with a BMI of 18.5 to 30, who exercise regularly and are training for a marathon. It's not suitable for those on anticoagulants or NSAIDs recently, recent hospital patients, smokers/drug users, pregnant women, or anyone with acute health issues like infections.

What is being tested?

The study tests how different intensities of exercise affect the body's acute phase response (APR), which involves inflammation and blood clotting processes. Participants will engage in varying exercises from walking to running a marathon to see which promotes better tissue repair without triggering harmful coagulation.

What are the potential side effects?

Since this trial involves graded physical activity up to marathon running, potential side effects include typical exercise-related risks such as muscle soreness, fatigue, dehydration, joint stress injuries and in extreme cases exertional heat illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to post-exercise/marathon (within 3 hours of exercise/marathon completion)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to post-exercise/marathon (within 3 hours of exercise/marathon completion)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to post-exercise/marathon (within 3 hours of exercise/marathon completion) 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 of fibrinolysis (mg/ml) before graded exercise/marathon participation and after graded exercise/marathon participation (physiological parameter)

Change of inflammatory response (mg/ml) before graded exercise/marathon participation and after graded exercise/marathon participation (physiological parameter)

Change of plasminogen (mg/ml) consumption before graded exercise/marathon participation and after graded exercise/marathon participation (physiological parameter)

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

Group I: Marathon ParticipationExperimental Treatment1 Intervention

On the day of the marathon prior to start, the participant will be seated for 10 minutes prior to measuring their baseline heart rate. A 4.5 mL blood sample will be collected prior to initiation of exercise. Immediately after completion of the marathon, a 4.5 mL blood draw will be completed. Additional 4.5 mL blood draws will be taken at 1 and 2 days post-marathon to measure to length of time required to return to baseline coagulation, fibrinolysis, and inflammation following the prolonged, intense exercise.

Group II: Graded ExerciseExperimental Treatment1 Intervention

Volunteers will participate in 3 study visits. The study visits will consist either of 20 minutes of walking, 20 minutes of running or 20 minutes of sitting. At the beginning of each study visit, prior to any exercise, a 4.5mL blood sample will be collected. The participant will then complete either 20 minutes of walking, running or sitting and will then have a 4.5mL blood draw taken from a new site.

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