Your session is about to expire
← Back to Search
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
Study 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.Check my eligibility
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.See study design
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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)
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.
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,157 Total Patients Enrolled
Jonathan Schoenecker, MD, PhDPrincipal InvestigatorVanderbilt Orthopaedics
1 Previous Clinical Trials
320 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant.You are planning to participate in a marathon.You have used blood thinners or pain relievers like aspirin, ibuprofen, or naproxen within the last 10 days.You have a history of smoking cigarettes or using illegal drugs.The first group will do a 20-minute exercise that gradually increases in intensity.Your body mass index (BMI) falls within a healthy range of 18.5 to 30.0.You are currently experiencing a severe illness such as an infection, broken bone, or asthma attack.You have existing health conditions or injuries that may make it unsafe for you to exercise during the study.You are currently training for a marathon or planning to run a marathon.You need to exercise moderately at least twice a week on a regular basis.
Research Study Groups:
This trial has the following groups:- Group 1: Marathon Participation
- Group 2: Graded Exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to volunteer for this experiment?
"Qualified applicants for this trial must have had a response to their initial treatment plan, be in the acute phase of their illness, and fall within an 18-49 year age range. The total number of candidates accepted is 35."
Answered by AI
Does this experiment impose an age restriction that precludes individuals under 50 from participating?
"According to the guidelines for this clinical trial, potential participants must be aged 18-49. For those under 18 or over 65, there are separate trials available."
Answered by AI
Are there any open opportunities to join this experiment?
"From the clinicaltrials.gov records, this trial is not currently open to recruitment. Although initially posted on November 29th 2017 and last updated in February 2021, no new candidates are being accepted for this study at present. Fortunately there are two other trials that patients can apply for instead."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger