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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT03398304
Status
Enrolling By Invitation

Conditions

  • Acute Phase Response

Eligibility Criteria

Sex
ALL
Age
18 Years - 49 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Nov 29, 2017
Status verified
May 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
35 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Graded Exercise
    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.
  • Experimental: Marathon Participation
    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.

Primary Outcome Measure

Change of fibrinolysis (mg/ml) before graded exercise/marathon participation and after graded exercise/marathon participation (physiological parameter) [ Time Frame: Baseline to post-exercise/marathon (within 3 hours of exercise/marathon completion) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt OrthopaedicsNashvilleTennessee37232-

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