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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04150952
Other study ID # UAL-HRV
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 7, 2019
Est. completion date December 7, 2019

Study information

Verified date May 2020
Source Universidad de Almeria
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Monitoring individual responses to training is an important key factor to prescribe to most effective training programs. A promising variable that is able to reflect positive or negative training adaptation is cardiac autonomic regulation. In general, a decreased training status is associated with a lower power output at the same submaximal heart rate and a slower heart rate recovery, whereas an increased training status is associated with an increased power output, the same submaximal heart rate, and a faster heart rate recovery.

In this line, heart-rate variability (HRV), which focuses on the variability of successive R-R intervals, have gained popularity in monitoring the training status of endurance athletes. This tool enables the detection of fatigue status and assesses the adaptation to training. After high intensity training or a short-term overreached period, there is a decrease in the resting HRV values, reflecting the effect of the fatigue. In addition, the increase of the performance after a training period is related to an increase in resting HRV. This direct fatigue measuring method has been little used to prescribe or regulate exercise prescription. Moreover, this HRV-guided training, also called day-to-day periodization, 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.

On the other hand, 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. This is another interesting line that pretends to be clarified in this study.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date December 7, 2019
Est. primary completion date December 7, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
HRV-based training
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.
TRAD training
Traditional endurance training

Locations

Country Name City State
Spain University of Almería Almería

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Fat mass Percentage of fat mass Change from baseline body composition at 8 weeks
Other Muscle mass Percentage of muscle mass Change from baseline body composition at 8 weeks
Other Bone mass Percentage of bone mass Change from baseline body composition at 8 weeks
Other Body water Percentage of body water Change from baseline body composition at 8 weeks
Other Height Height in meters Change from baseline height at 8 weeks
Other Weight Weight in kilograms Change from baseline weight at 8 weeks
Other Heart Rate Variability Change (LnrMSSD) Parasympathetic tone and recovery indicator Change from Baseline Heart Rate Variability at 8 weeks
Primary VO2max Maximal oxygen consumption in treadmill test Change from baseline VO2max at 8 weeks
Secondary maximal heart rate maximal heart rate in the treadmill test Change from baseline maximal heart rate at 8 weeks
Secondary maximal speed maximal speed in the treadmill test Change from baseline maximal speed at 8 weeks
Secondary ventilatory thresolds ventilatory thresolds in the treadmill test Change from baseline ventilatory thresolds at 8 weeks
Secondary respiratory quotient respiratory quotient in the treadmill test Change from baseline respiratory quotient at 8 weeks
Secondary Time in running test Time in the 3000 meters running test Change from baseline time at 8 weeks
Secondary Lactate change Lactate change after the 3000m test Change from baseline Lactate at 8 weeks
Secondary Speed in running test Speed in the 3000 meters running test Change from baseline speed at 8 weeks
Secondary Heart rate in running test Heart rate in the 3000 meters running test Change from baseline heart rate at 8 weeks
Secondary Börg scale after running test Subjective perceived exertion. Scores goes from 0 to 10. Higher scores indicate a higher perceived exertion. Through study completion (8 weeks)
Secondary LnrMSSD score Parasympathetic tone and recovery indicator. There are no minimum or maximum values. They depend on the athlete recovery state. Higher scores indicate a better outcome. Through study completion (8 weeks)
Secondary Mood score Precompetitive mood levels. Instrument: Profile of Mood States. Scores goes from 0 (low mood) to 4 (high mood). Through study completion (8 weeks)
Secondary Anxiety score Precompetitive anxiety levels. Instrument: Revised Competitive State Anxiety Inventory-2. Scores goes from 1 (no anxiety) to 4 (a lot of anxiety). Through study completion (8 weeks)
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