- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04150952
HRV-based Training Effects in Athletes (HRV-btA)
Physiological and Psychological Effects of Heart Rate Variability Based Training in Endurance Athletes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Almería, Spain, 04120
- University of Almeria
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HRV-Group
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.
|
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.
|
|
Active Comparator: TRAD-Group
Athletes will train according to their trainer plan.
Training will not be guided by their basal HRV scores.
|
Traditional endurance training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VO2max
Time Frame: Change from baseline VO2max at 8 weeks
|
Maximal oxygen consumption in treadmill test
|
Change from baseline VO2max at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
maximal heart rate
Time Frame: Change from baseline maximal heart rate at 8 weeks
|
maximal heart rate in the treadmill test
|
Change from baseline maximal heart rate at 8 weeks
|
|
maximal speed
Time Frame: Change from baseline maximal speed at 8 weeks
|
maximal speed in the treadmill test
|
Change from baseline maximal speed at 8 weeks
|
|
ventilatory thresolds
Time Frame: Change from baseline ventilatory thresolds at 8 weeks
|
ventilatory thresolds in the treadmill test
|
Change from baseline ventilatory thresolds at 8 weeks
|
|
respiratory quotient
Time Frame: Change from baseline respiratory quotient at 8 weeks
|
respiratory quotient in the treadmill test
|
Change from baseline respiratory quotient at 8 weeks
|
|
Time in running test
Time Frame: Change from baseline time at 8 weeks
|
Time in the 3000 meters running test
|
Change from baseline time at 8 weeks
|
|
Lactate change
Time Frame: Change from baseline Lactate at 8 weeks
|
Lactate change after the 3000m test
|
Change from baseline Lactate at 8 weeks
|
|
Speed in running test
Time Frame: Change from baseline speed at 8 weeks
|
Speed in the 3000 meters running test
|
Change from baseline speed at 8 weeks
|
|
Heart rate in running test
Time Frame: Change from baseline heart rate at 8 weeks
|
Heart rate in the 3000 meters running test
|
Change from baseline heart rate at 8 weeks
|
|
Börg scale after running test
Time Frame: Through study completion (8 weeks)
|
Subjective perceived exertion.
Scores goes from 0 to 10. Higher scores indicate a higher perceived exertion.
|
Through study completion (8 weeks)
|
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LnrMSSD score
Time Frame: Through study completion (8 weeks)
|
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)
|
|
Mood score
Time Frame: Through study completion (8 weeks)
|
Precompetitive mood levels.
Instrument: Profile of Mood States.
Scores goes from 0 (low mood) to 4 (high mood).
|
Through study completion (8 weeks)
|
|
Anxiety score
Time Frame: Through study completion (8 weeks)
|
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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fat mass
Time Frame: Change from baseline body composition at 8 weeks
|
Percentage of fat mass
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Change from baseline body composition at 8 weeks
|
|
Muscle mass
Time Frame: Change from baseline body composition at 8 weeks
|
Percentage of muscle mass
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Change from baseline body composition at 8 weeks
|
|
Bone mass
Time Frame: Change from baseline body composition at 8 weeks
|
Percentage of bone mass
|
Change from baseline body composition at 8 weeks
|
|
Body water
Time Frame: Change from baseline body composition at 8 weeks
|
Percentage of body water
|
Change from baseline body composition at 8 weeks
|
|
Height
Time Frame: Change from baseline height at 8 weeks
|
Height in meters
|
Change from baseline height at 8 weeks
|
|
Weight
Time Frame: Change from baseline weight at 8 weeks
|
Weight in kilograms
|
Change from baseline weight at 8 weeks
|
|
Heart Rate Variability Change (LnrMSSD)
Time Frame: Change from Baseline Heart Rate Variability at 8 weeks
|
Parasympathetic tone and recovery indicator
|
Change from Baseline Heart Rate Variability at 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Alberto González Quílez, Master, Universidad de Almeria
- Principal Investigator: Antonio Granero-Gallegos, PhD, Universidad de Almeria
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UAL-HRV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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