Acute Phase ResponseNCT03398304
Defining the Temporal Changes in the Acute Phase Response During Graded Exercise: A Prospective Study
A study testing Graded Exercise and Marathon participation in people with Acute Phase Response, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Phase Response
- What is being tested?
- Graded Exercise and Marathon participation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2017to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 16Show fewer
- Arm 2: Marathon participation Inclusion criteria
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- 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.
- To track the APR through modulated exercise in order to determine the type of exercise that enhances physiologic benefit and limits harm.
Read the detailed description
Injury, ranging from a paper cut that barely splits the skin to a high-speed motor vehicle accident that rips through muscle and bone, causes a disruption of tissue compartments. This breach of compartments disposes tissue to four principle problems: 1) bleeding, 2) susceptibility to infection, 3) hypoxia, and 4) tissue dysfunction. The acute phase response (APR) is the physiologic system that resolves these four problems of injury. It is divided into two temporally distinct phases: survival and repair. The survival phase utilizes coagulation and inflammation to temporarily seal off breached compartments in order to stop bleeding and prevent the spread of infection. Once the life-threatening problems of hemorrhage and susceptibility to infection have been resolved, the body enters the repair phase, where it works to restore the disrupted blood supply and regenerate damaged tissue. These processes, coupled together, replace the temporary sealant and restore the injured tissue to its original form and function.
Plasmin is the key fibrinolytic protease that transitions the APR from survival to repair. Plasmin is traditionally known for its ability to degrade fibrin clots. Previous work has demonstrated that plasmin also activates many targets outside of fibrin degradation that are essential for musculoskeletal tissue healing. Plasmin initiates the repair of injured tissue by removing the temporary fibrin sealant required for hemostasis, which allows access for repair machinery to enter the site of injury. Subsequently, plasmin activates proteases that promote angiogenesis and cell differentiation to stimulate tissue regeneration. Without adequate plasmin activity, the body fails to transition from survival to repair and is unable to reconstitute the compartments damaged by injury.
All tissue injury activates the acute phase response. Exercise is a form of contained tissue injury that harnesses the beneficial effects of the acute phase response to build muscle and promote overall health. Given that the controlled injury of exercise minimizes compartment disruption, there is a limited need to mount a response to hemorrhage or containment of infection (survival). Exercise increases the metabolic requirement of muscle to the point that it outstrips the supply of oxygenated blood and results in sustained hypoxia. In response to hypoxia, plasmin stimulates angiogenesis and activates cells involved in tissue regeneration (repair). In exercise physiology, if major injury is avoided, the body thereby bypasses the survival phase and transitions into an early and prolonged repair phase.
Despite studies demonstrating alterations in the APR with exercise, the relationship between the intensity of exercise and the extent of APR activation is not yet well defined [8-10]. Our aim is to gain a better understanding of the precise changes in the APR in order to maximize the reparative potential of exercise. We hypothesize that moderate intensity exercise selectively enhances plasmin-mediated fibrinolysis (repair) without inducing the procoagulant arm of the APR (survival). Additionally, we propose that the systemic activation of fibrinolysis achieved in exercise promotes global tissue health at spatially distinct locations in addition to the site of initial tissue injury (hypoxic muscle). To evaluate this, we will define the precise temporal changes in the APR in healthy individuals participating in graded intensities of exercise (rest, light, and moderate). Through elucidation of the precise temporal activation of the APR as it relates to the intensity of exercise, it may allow future studies to develop an exercise regimen that harnesses the reparative potential of fibrinolysis while avoiding the potentially harmful activation of the procoagulant survival phase of the APR.
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
- 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.
- 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
- Being tested
- Graded Exercise, Marathon participation
- Medical subject headings
- Acute-Phase Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded ExerciseOther
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 participationOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Marathon participation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to post-exercise/marathon (within 3 hours of exercise/marathon completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start29 Nov 2017
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Phase ResponseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon Schoenecker, Vanderbilt University Medical Center
- Investigators
- Jonathan Schoenecker, MD, PhD, Principal investigator, Vanderbilt Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398304
- Sponsor's protocol ID
- 171641
- Status last verified
- May 2026
- First submitted
- 21 Dec 2017
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Temporal Changes in the Acute Phase Response During Graded Exercise: A Prospective Study
- ClinicalTrials.gov ID
- NCT03398304
- Acronym / sponsor ID
- 171641
- Conditions
- Acute Phase Response
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- To track the APR through modulated exercise in order to determine the type of exercise that enhances physiologic benefit and limits harm.
Detailed description
Injury, ranging from a paper cut that barely splits the skin to a high-speed motor vehicle accident that rips through muscle and bone, causes a disruption of tissue compartments. This breach of compartments disposes tissue to four principle problems: 1) bleeding, 2) susceptibility to infection, 3) hypoxia, and 4) tissue dysfunction. The acute phase response (APR) is the physiologic system that resolves these four problems of injury. It is divided into two temporally distinct phases: survival and repair. The survival phase utilizes coagulation and inflammation to temporarily seal off breached compartments in order to stop bleeding and prevent the spread of infection. Once the life-threatening problems of hemorrhage and susceptibility to infection have been resolved, the body enters the repair phase, where it works to restore the disrupted blood supply and regenerate damaged tissue. These processes, coupled together, replace the temporary sealant and restore the injured tissue to its original form and function.
Plasmin is the key fibrinolytic protease that transitions the APR from survival to repair. Plasmin is traditionally known for its ability to degrade fibrin clots. Previous work has demonstrated that plasmin also activates many targets outside of fibrin degradation that are essential for musculoskeletal tissue healing. Plasmin initiates the repair of injured tissue by removing the temporary fibrin sealant required for hemostasis, which allows access for repair machinery to enter the site of injury. Subsequently, plasmin activates proteases that promote angiogenesis and cell differentiation to stimulate tissue regeneration. Without adequate plasmin activity, the body fails to transition from survival to repair and is unable to reconstitute the compartments damaged by injury.
All tissue injury activates the acute phase response. Exercise is a form of contained tissue injury that harnesses the beneficial effects of the acute phase response to build muscle and promote overall health. Given that the controlled injury of exercise minimizes compartment disruption, there is a limited need to mount a response to hemorrhage or containment of infection (survival). Exercise increases the metabolic requirement of muscle to the point that it outstrips the supply of oxygenated blood and results in sustained hypoxia. In response to hypoxia, plasmin stimulates angiogenesis and activates cells involved in tissue regeneration (repair). In exercise physiology, if major injury is avoided, the body thereby bypasses the survival phase and transitions into an early and prolonged repair phase.
Despite studies demonstrating alterations in the APR with exercise, the relationship between the intensity of exercise and the extent of APR activation is not yet well defined [8-10]. Our aim is to gain a better understanding of the precise changes in the APR in order to maximize the reparative potential of exercise. We hypothesize that moderate intensity exercise selectively enhances plasmin-mediated fibrinolysis (repair) without inducing the procoagulant arm of the APR (survival). Additionally, we propose that the systemic activation of fibrinolysis achieved in exercise promotes global tissue health at spatially distinct locations in addition to the site of initial tissue injury (hypoxic muscle). To evaluate this, we will define the precise temporal changes in the APR in healthy individuals participating in graded intensities of exercise (rest, light, and moderate). Through elucidation of the precise temporal activation of the APR as it relates to the intensity of exercise, it may allow future studies to develop an exercise regimen that harnesses the reparative potential of fibrinolysis while avoiding the potentially harmful activation of the procoagulant survival phase of the APR.
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
- 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.
- To track the APR through modulated exercise in order to determine the type of exercise that enhances physiologic benefit and limits harm.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graded Exercise | Experimental | Other: Graded ExerciseVolunteers 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. |
| Marathon Participation | Experimental | Other: Marathon participationOn 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graded ExerciseStudy 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. | Other | Graded Exercise |
| Marathon participationStudy 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. | Other | Marathon Participation |
Primary outcome
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)
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.
Change of plasminogen (mg/ml) consumption 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)
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.
Change of inflammatory response (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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Schoenecker, MD, PhD principal investigator
Vanderbilt Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graded Exercise and Marathon participation in people with Acute Phase Response, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.