What this study is
The purpose of this study is to detail the precise temporal changes in the APR that occur in response to exercise in order to determine the types of exercise that confer maximal reparative fibrinolysis. Published research and preliminary studies conducted in our lab suggest that different types of exercise will preferentially activate fibrinolysis over coagulation, thereby promoting improved global tissue health [8]. As such, measuring markers of the APR in healthy individuals 1) at rest, 2) walking (light intensity exercise), 3) running (moderate intensity exercise), and 4) following endurance running (a marathon) will allow us to establish a baseline for the temporal changes in the APR that avoid activation of the procoagulant survival phase while maximizing the repair phase.
Specific aims
1. To measure the acute phase response fibrinolysis, plasminogen consumption, and inflammatory profiles of healthy individuals before and after graded exercise (at rest, light intensity, medium intensity) and after prolonged exercise at medium intensity as defined by changes in fibrinolysis, plasminogen consumption, and inflammatory response. 2. To track the APR through modulated exercise in order to determine the type of exercise that enhances physiologic benefit and limits harm.
What's being tested
- Graded Exercise
Intervention · OTHER
Study arm 1 (Graded Exercise) participants will complete either 20 minutes of mild or moderate intensity at 2 different study visits. The third study visit will consist of 20 minutes of sitting.
- Marathon participation
Intervention · OTHER
Study arm 2 (Marathon participation) participants will take part in a marathon. 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.
Study details
- Sponsor
- Vanderbilt University Medical Center
- Conditions
- Acute Phase Response
- Enrolling
- 35 people
- Starts
- 2017-11-29
- Est. completion
- 2027-04-01
- Design
- Open-label, non-randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 49 YearsSex ALLHealthy volunteers AcceptedAll participants
You may qualify if
- Arm 1: 20-minute graded exercise
- Healthy individuals (male or female) aged 18-29
- Regular participation (at least 2 times per week) in moderate intensity exercise
- BMI between 18.5 and 30.0
You can't join if
- Pre-existing health conditions or injuries that may limit the ability to safely participate in exercise
- Acute disease process such as an infection, broken bone, or asthma attack
- Chronic or recent use (within the last 10 days) of any anticoagulant medication or NSAID
- Pregnant women
- Recent inpatient admission within the last six months
- History of smoking or illicit drug use
Arm 2: Marathon participation
You may qualify if
- Healthy individuals (male or female) aged 18-49
- In training to complete a marathon (individuals already planning on running a marathon and training accordingly for it)
- BMI between 18.5 and 30.0
You can't join if
- Pre-existing health conditions or injuries that may limit the ability to safely participate in exercise
- Acute disease process such as an infection, broken bone, or asthma attack
- Chronic or recent use (within the last 10 days) of any anticoagulant medication or NSAID
- Pregnant women
- Recent inpatient admission within the last six months
- History of smoking or illicit drug use
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVanderbilt Orthopaedics
Nashville, Tennessee, United States
Study team
Sponsor
Vanderbilt University Medical Center
Study ID 171641
Principal investigator
Jonathan Schoenecker, MD, PhD
Vanderbilt Orthopaedics
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.