Defining the Temporal Changes in the Acute Phase Response During Graded Exercise: A Prospective Study

NCT03398304 | Enrolling By Invitation

• 1 other identifier: 171641
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.To track the APR through modulated exercise in order to determine the type of exercise that enhances physiologic benefit and limits harm.

Conditions

Acute Phase Response

Outcome Measures

Primary Outcomes (3)

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

  To measure the acute phase response fibrinolysis, plasminogen consumption, and inflammatory profiles of healthy individuals before and after graded exercise (at rest, light intensity, and medium intensity) and following endurance running, as defined by changes in fibrinolysis, plasminogen consumption, and inflammatory response.

  Baseline to post-exercise/marathon (within 3 hours of exercise/marathon completion)

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

  To measure the acute phase response fibrinolysis, plasminogen consumption, and inflammatory profiles of healthy individuals before and after graded exercise (at rest, light intensity, and medium intensity) and following endurance running, as defined by changes in fibrinolysis, plasminogen consumption, and inflammatory response.

  Baseline to post-exercise/marathon (within 3 hours of exercise/marathon completion)

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

  To measure the acute phase response fibrinolysis, plasminogen consumption, and inflammatory profiles of healthy individuals before and after graded exercise (at rest, light intensity, and medium intensity) and following endurance running, as defined by changes in fibrinolysis, plasminogen consumption, and inflammatory response.

  Baseline to post-exercise/marathon (within 3 hours of exercise/marathon completion)

Study Arms (2)

Graded Exercise

EXPERIMENTAL

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.

Other: Graded Exercise

Marathon Participation

EXPERIMENTAL

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.

Other: Marathon participation

Interventions

Graded Exercise 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.

Graded Exercise

Marathon participation 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.

Marathon Participation

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 may not qualify 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
• 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
• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt Orthopaedics

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Acute-Phase Reaction

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Schoenecker, MD, PhD

  Vanderbilt Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedic Surgery, Associate Professor of Pediatrics

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: January 12, 2018
• Study Start: November 29, 2017
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)