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Performance Determinants Factors in Elite Endurance Athletes.

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ClinicalTrials.gov Identifier: NCT03569566
Recruitment Status : Enrolling by invitation
First Posted : June 26, 2018
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Telemark University College

Brief Summary:
Several studies have investigated determinant factors for endurance performance among different athletes, untrained individuals and patients focusing on the impact of age, genes and training intensity. A further step in this research will be to investigate the impact of age, genes, training intensity and history of tick-bourne disease on endurance performance in elite endurance athletes. We are planning a project with a two-step model. In step one we will, in a cross-sectional study design, investigate potential relationships between age, training intensity, training volume, genes, exosomes and history of tick-bourne disease and physiological variables and endurance performance. In step two we will investigate differences in training adaptation by observing and monitoring all training done by the participants during a 6-months period. The participants will be tested for several physiological variables before, after 3- months and after this period. We will also investigate the impact of age, training intensity, training volume, genes and history of tick-bourne disease on the results from the physiological tests and performance.

Condition or disease Intervention/treatment
Exercise Physiology Other: Age, Genes, Training, Tickbourne Disease and Endurance

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Impact of Age, Genes, Training and History of Tickbourne Disease on Endurance Performance in Elite Endurance Athletes.
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Elite endurance athletes
Cross-country skiers at high national level
Other: Age, Genes, Training, Tickbourne Disease and Endurance
Testing of genes, exosomes, physiological variables, tick-bourne disease markers, observation of training modality and performance




Primary Outcome Measures :
  1. Time trail cross-country roller skiing performance [ Time Frame: Change from baseline performance at 3-months and at 6-months ]
    Testing of seconds used in a predefined track

  2. Maximal oxygen consumption [ Time Frame: Change from baseline maximal oxygen uptake at 3-months and at 6-months ]
    Standard ergospirometrical incremental test in running and double-poling


Secondary Outcome Measures :
  1. Lactate threshold in double poling [ Time Frame: Change from baseline lactate threshold at 3-months and at 6-months ]
    Onset of blood lactate accumulation in an incremental interval protocol

  2. Double poling economy [ Time Frame: Change from baseline economy at 3-months and at 6-months ]
    Ergospirometrical measurement of oxygen consumption per meter poling

  3. Maximal strength [ Time Frame: Change from baseline maximal strength at 3-months and at 6-months ]
    Kilograms measured in one repetition maximum in half-squat and pull-down

  4. Jump height [ Time Frame: Change from baseline jump height at 3-months and at 6-months ]
    Centimeters measured on force platform in squat jump, counter movement jump and countermovement jump with armswing

  5. Genotypes [ Time Frame: Baseline ]
    Distribution of alleles for candidate genes derrived from blood samples

  6. Tick-bourne disease [ Time Frame: Baseline ]
    Blood markers for previous tick-bourne disease

  7. Exosomes [ Time Frame: Baseline ]
    Quantifying number of exosomes in blood immediately before and after maximal aerobic work and maximal strength tests

  8. Training volume [ Time Frame: Change from baseline training volume at 3-months and at 6-months ]
    Registration of training volume in hours from training diaries

  9. Training intensity [ Time Frame: Change from baseline training intensity at 3-months and at 6-months ]
    Registration of training intensity by use of heart rate measures corresponding to the training intensity scale made by the Norwegian Olympic Sports Center.

  10. Age [ Time Frame: Baseline ]
    Age in years

  11. Maximal power [ Time Frame: Change from baseline power at 3-months and at 6-months ]
    Maximal power in watt in half-squat and pull-down


Biospecimen Retention:   Samples With DNA

Blood samples will be taken, and will be used for the following purposes:

  • DNA isolation and analysis: DNA genome will be isolated from white blood cells. This DNA genome will be contained in a biobank - Exercise Genetics. Well-known genetic variations in genes will be tested showing relevance to training adaptations (ACE, ACTN3 etc.). Only known polymorphisms will be investigated.
  • Exosome isolation from plasma: We will isolate exosomes from plasma by the ultracentrifugation method. We will investigate the volume and specific types of exosomes, in relation to the training intervention. We also want to examine the exosome-cargo, like miRNA, protein content, mRNA and DNA content.
  • Isolation of antibodies from plasma: We want to investigate antibodies to examine potential on-going disease, recently disease or earlier disease of Barbesia, Anaplasma or other actual tick-borne agens. We also want to isolate DNA from blood and use real-time PCR for anaplasma and Neo Ehrlichia analysis.


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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cross-country skiers at high national or international level
Criteria

Inclusion Criteria:

  • age between 16 and 50
  • active competition athletes competing on a national level or above
  • athletes who write training diaries

Exclusion Criteria:

  • Sickness and/or injury who contra indicates normal training and maximal testing.
  • An on-going infection or injury.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569566


Locations
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Norway
Telemark University College
Bø, Telemark, Norway, 3800
Sponsors and Collaborators
Telemark University College
Norwegian University of Science and Technology
Investigators
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Study Chair: Pål Augestad, PhD Telemark University College

Publications:
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Responsible Party: Telemark University College
ClinicalTrials.gov Identifier: NCT03569566     History of Changes
Other Study ID Numbers: 2017/2522
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Telemark University College:
Age
Genes
Training volume
Training intensity
Tick-bourne disease
Endurance performance
Elite endurance athletes