NCT03569566

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

June 27, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 4, 2022

Status Verified

December 1, 2021

Enrollment Period

3.5 years

First QC Date

May 28, 2018

Last Update Submit

August 3, 2022

Conditions

Keywords

AgeGenesTraining volumeTraining intensityTick-bourne diseaseEndurance performanceElite endurance athletes

Outcome Measures

Primary Outcomes (2)

  • Time trail cross-country roller skiing performance

    Testing of seconds used in a predefined track

    Change from baseline performance at 3-months and at 6-months

  • Maximal oxygen consumption

    Standard ergospirometrical incremental test in running and double-poling

    Change from baseline maximal oxygen uptake at 3-months and at 6-months

Secondary Outcomes (11)

  • Lactate threshold in double poling

    Change from baseline lactate threshold at 3-months and at 6-months

  • Double poling economy

    Change from baseline economy at 3-months and at 6-months

  • Maximal strength

    Change from baseline maximal strength at 3-months and at 6-months

  • Jump height

    Change from baseline jump height at 3-months and at 6-months

  • Genotypes

    Baseline

  • +6 more secondary outcomes

Study Arms (1)

Elite endurance athletes

Cross-country skiers at high national level

Other: Age, Genes, Training, Tickbourne Disease and Endurance

Interventions

Testing of genes, exosomes, physiological variables, tick-bourne disease markers, observation of training modality and performance

Elite endurance athletes

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Cross-country skiers at high national or international level

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Telemark University College

Bø, Telemark, 3800, Norway

Location

Related Publications (4)

  • Storen O, Bratland-Sanda S, Haave M, Helgerud J. Improved VO2max and time trial performance with more high aerobic intensity interval training and reduced training volume: a case study on an elite national cyclist. J Strength Cond Res. 2012 Oct;26(10):2705-11. doi: 10.1519/JSC.0b013e318241deec.

    PMID: 22124353BACKGROUND
  • Ingjer, F. Maximal oxygen uptake as a predictor of performance ability in women and men elite cross-country skiers. Scand. J. Med. Sci. Sports. 1: 25-30, 1991.

    BACKGROUND
  • Storen O, Ulevag K, Larsen MH, Stoa EM, Helgerud J. Physiological determinants of the cycling time trial. J Strength Cond Res. 2013 Sep;27(9):2366-73. doi: 10.1519/JSC.0b013e31827f5427.

    PMID: 23238091BACKGROUND
  • Storen O, Ronnestad BR, Sunde A, Hansen J, Ellefsen S, Helgerud J. A time-saving method to assess power output at lactate threshold in well-trained and elite cyclists. J Strength Cond Res. 2014 Mar;28(3):622-9. doi: 10.1519/JSC.0b013e3182a73e70.

    PMID: 23942166BACKGROUND

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.

MeSH Terms

Interventions

AgingGenes

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological PhenomenaGenome ComponentsGenomeGenetic StructuresGenetic Phenomena

Study Officials

  • Pål Augestad, PhD

    University of South-Eastern Norway

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2018

First Posted

June 26, 2018

Study Start

June 27, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

August 4, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations