The Effect of Strenuous Exercise on Coagulation.

The Effect of Strenuous Exercise on Coagulation: Hemostatic Behaviour Before and After Amstel Gold Race

Many studies have shown that vigorous exercise increases the risk of developing vascular thrombotic events and can result in sudden death during or immediately after exercise. The outcome of these studies is biased by several confounding variables: subjects, type of exercise, duration, intensity and especially the method used for the evaluation of the hemostatic capacity. The goal of our study is to investigate the effect of strenuous exercise with the Calibrated Automated Thrombogram (CAT) assay, which is an established tool in detecting hyper- and hypocoagulabilty conditions. We modified the CAT assay to make it also feasible to measure TG in whole blood (WB-CAT), not only to go one step closer to physiology since all the blood cells are present, but also to avoid the centrifugation step. With our study we would like to see whether the other blood cells also play a role in the increase in TG. The objective is to investigate the effect of strenuous exercise (participation to the Amstel Gold Race) on coagulation and haemostatic parameters. We hypothesize that strenuous exercise induces a prothrombotic phenotype and that especially the tests involving blood cells will be altered into a prothrombotic phenotype.

Study Overview

• Status: Completed
• Conditions: The Effect of Strenuous Exercise on Haemostasis.

• Study Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229EV
      • Synapse bv

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy participants of the Amstel Gold Race for non-professionals will be asked to join our study.

Description

Inclusion Criteria:

• Healthy subjects not taking any medication interfering with coagulation that are willing to donate 18 ml of blood via venipuncture and a capillary blood drop via fingerpuncture before and after the Amstel Gold Race.
• Between 18 and 50 years of age. We take 50 year as a maximal age to prevent any co-morbidity that could have an influence on coagulation (like diabetes, atherosclerosis, peripheral arterial disease, …).

Exclusion Criteria:

• Subjects taking any medication interfering with coagulation.
• Subjects having a cardiovascular disease or any other serious medical problem.
• Subjects below 18 years or above 50 years of age.
• Subjects that smoke.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cyclists

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of strenuous exercise on thrombin generation and other coagulation tests.	Thrombin generation will be done in whole blood and plasma. The parameters we will study at are: the peak height, ETP, lagtime, time-to-peak and velocity index. Routine coagulation tests (APTT, PT, INR, platelet count, haematocrit, fibrinolysis assay, FACS, ROTEM, ABO-determination, dRVVT-X, D-dimers) Measurements of coagulations factor levels (II, V, VII, VIII, IX, X, XI, XII, fibrinogen, protein S and C, ADAMTS-13)	Before and after the Amstel Gold Race (around 6 hours)

Collaborators and Investigators

• Sponsor: Synapse bv
• Collaborators: Maastricht University

Publications and helpful links

General Publications

• Huskens D, Roest M, Remijn JA, Konings J, Kremers RM, Bloemen S, Schurgers E, Selmeczi A, Kelchtermans H, van Meel R, Meex SJ, Kleinegris MC, de Groot PG, Urbanus RT, Ninivaggi M, de Laat B. Strenuous exercise induces a hyperreactive rebalanced haemostatic state that is more pronounced in men. Thromb Haemost. 2016 Jun 2;115(6):1109-19. doi: 10.1160/TH15-10-0821. Epub 2016 Feb 11.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: January 23, 2014
• First Submitted That Met QC Criteria: January 27, 2014
• First Posted (Estimate): January 29, 2014

Study Record Updates

• Last Update Posted (Estimate): November 25, 2014
• Last Update Submitted That Met QC Criteria: November 24, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: NL47367.068.13