NCT04150952

Brief Summary

Monitoring individual responses to training is an important key factor to prescribe to most effective training programs. Heart-rate variability (HRV) could be used for monitoring the training status of endurance athletes in order to detect the fatigue status and to assess the adaptation to training. This direct fatigue measuring method has been little used to prescribe or regulate exercise prescription. Moreover, it allows new possibilities for the training load prescription according to an athlete's status, the response to the training load, and the adaptation to training. Regardless HRV-guided training, the athlete performance could also be influenced by precompetitive mood and anxiety, which can also be reflected in the precompetitive HRV scores and the subjective effort perception.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 7, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2019

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

October 24, 2019

Last Update Submit

May 25, 2020

Conditions

Keywords

Heart rate variabilityTrainingEnduranceMoodAnxietyStressmaximal oxygen consumption

Outcome Measures

Primary Outcomes (1)

  • VO2max

    Maximal oxygen consumption in treadmill test

    Change from baseline VO2max at 8 weeks

Secondary Outcomes (12)

  • maximal heart rate

    Change from baseline maximal heart rate at 8 weeks

  • maximal speed

    Change from baseline maximal speed at 8 weeks

  • ventilatory thresolds

    Change from baseline ventilatory thresolds at 8 weeks

  • respiratory quotient

    Change from baseline respiratory quotient at 8 weeks

  • Time in running test

    Change from baseline time at 8 weeks

  • +7 more secondary outcomes

Other Outcomes (7)

  • Fat mass

    Change from baseline body composition at 8 weeks

  • Muscle mass

    Change from baseline body composition at 8 weeks

  • Bone mass

    Change from baseline body composition at 8 weeks

  • +4 more other outcomes

Study Arms (2)

HRV-Group

EXPERIMENTAL

Athletes will train according to their basal HRV scores. If the resting HRV is higher tan their basal HRV, they will perform a high or moderate intensity training. If the resting HRV is lower, they will perform a low intensity training. If the resting HRV still lower, they will rest. They will not accumulate two or more days of high-moderate intensity training, nor two or more days of rest.

Other: HRV-based training

TRAD-Group

ACTIVE COMPARATOR

Athletes will train according to their trainer plan. Training will not be guided by their basal HRV scores.

Other: TRAD training

Interventions

Intervention based on HRV-guided training for the performance improvement of athletes. Pre-competitive HRV, subjective effort perception, anxiety and mood will also be analysed.

HRV-Group

Traditional endurance training

TRAD-Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Belonging to the Spanish Athletics Federation.
  • Training and running in Spanish Athletics Federation contest during at least two years.
  • Stay in the first third of the classification of the previous season last five races.

You may not qualify if:

  • Cardiovascular pathologies.
  • Parameters of blood pressure (BP) outside of normality.
  • Respiratory problems diagnosed.
  • Be in treatment of psychological problems.
  • Regular consumption of drug (s) with direct or indirect effects on the Nervous System (e.g., anxiolytics, antidepressants, neuroleptics).
  • Consumption of substances not permitted by the International Athletics Federation (IAF).
  • Punctual consumption of medication that could alter the performance due to suffering some disease related to cardiorespiratory system (e.g., influenza).
  • Do not attend at least the 90% of the workouts during the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Almería

Almería, 04120, Spain

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Alberto González Quílez, Master

    Universidad de Almeria

    STUDY CHAIR
  • Antonio Granero-Gallegos, PhD

    Universidad de Almeria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2019

First Posted

November 5, 2019

Study Start

September 7, 2019

Primary Completion

December 7, 2019

Study Completion

December 7, 2019

Last Updated

May 27, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations