NCT01463761

Brief Summary

Sports training aims to enhance an athlete's performance (overcompensation). To do that, the athlete must go through periods of fatigue and lower performance (overreaching). When the training plan is balanced, this fatigue is short and reversible.If the training load is too heavy or if recuperation periods are too short, it can lead to persistence fatigue that may only be reversible in the long term. This state of fatigue is part of the broader clinical picture of overtraining, which includes stark changes in performance as well as mood and sleep disorders. Many prediction and characterization methods based on biological markers have been evaluated, but they have not been put into practice in sports training due to obstacles such as reliability, interindividual variability and high costs. This study aims to evaluate a new approach based on the variability of an individual's heart rate (RR variability), which is a way of measuring autonomic nervous system (ASN) activity. It is non-invasive, low-cost, and has already proven useful in athlete health monitoring.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2010

Typical duration for all trials

Geographic Reach
1 country

8 active sites

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

Study Start

First participant enrolled

July 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

Enrollment Period

2.4 years

First QC Date

October 31, 2011

Last Update Submit

March 5, 2013

Conditions

AthletesTrainingFatigue

Keywords

High-level athleteANS activityOvertraining

Outcome Measures

Primary Outcomes (2)

  • Autonomic nervous system (ANS) activity

    This ANS is mesured during the night using a spectral analysis of nocturnal heart rate variability.

    One year

  • Fatigue and physical training

    Fatigue and physical training potetially due to overtraining, suspected based on a very significant, long-term worsening in performance

    One year

Secondary Outcomes (5)

  • kinetic of the ANS activity

    Every 15 days (from the iclusion to one year)

  • orthostasis test

    Every 15 days (from inclusion to one year)

  • French Society of Sports Medicine questionnaire

    Every 15 days (from inclusion to one year)

  • POMS (Profile of Mood States) questionnaire

    Every 3 months (from inclusion to inclusion)

  • Sleep quality questionnaire

    Every 3 months (from inclusion to one year)

Study Arms (1)

high-level athletes

High-level athlete, enrolled in a Ministry-recognized Pôle

Device: ANS activity

Interventions

ANS activityDEVICE

This ANS activity is measured by nocturnal heart rates records with Holter ECG.

high-level athletes

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

High-level athlete, enrolled in a Ministry-recognized Pôle

You may qualify if:

  • High-level athlete, enrolled in a Ministry-recognized Pôle
  • Participant signed the informed consent form

You may not qualify if:

  • Confirmed current overtraining syndrome
  • Athlete using cardio-inhibitor or cardio-accelerator drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

CH Albertville Moutiers

Albertville, 73200, France

Location

CHU de Besançon

Besançon, 25000, France

Location

Université Paris XIII

Bobigny, 93000, France

Location

CHU de Grenoble

Grenoble, 38000, France

Location

CHU de Pointe à Pitre

Pointe à Pitre, 97110, France

Location

CNSN Centre médical de Prémanon

Prémanon, 39400, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

CREPS Toulouse Midi Pyrénées

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Frederic ROCHE, MD PhD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

  • Xavier BIGARD, MD PhD

    Institut de Recherche Biomédicales des Armées

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

October 31, 2011

First Posted

November 2, 2011

Study Start

July 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 6, 2013

Record last verified: 2013-03

Locations

FR(8)