Heart Rate ControlHRV-btANCT04150952
HRV-based Training Effects in Athletes
A study testing HRV-based training and TRAD training in people with Heart Rate Control and Athlete, run by Universidad de Almeria at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Control, Athlete, Emotions
- What is being tested?
- HRV-based training and TRAD training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- 7 Sep 2019to 7 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological and Psychological Effects of Heart Rate Variability Based Training in Endurance Athletes
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.
Read the 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.
- Conditions
- Heart Rate Control, Athlete, Emotions
- Being tested
- HRV-based training, TRAD training
- Keywords
- Heart rate variability, Training, Endurance, Mood, Anxiety, Stress, maximal oxygen consumption
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRV-based trainingOther
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 trainingOther
Traditional endurance training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: TRAD training |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max
Maximal oxygen consumption in treadmill test
Measured: Change from baseline VO2max at 8 weeks
Secondary outcomes (12)
maximal heart rate
maximal heart rate in the treadmill test
Measured: Change from baseline maximal heart rate at 8 weeks
maximal speed
maximal speed in the treadmill test
Measured: Change from baseline maximal speed at 8 weeks
ventilatory thresolds
ventilatory thresolds in the treadmill test
Measured: Change from baseline ventilatory thresolds at 8 weeks
respiratory quotient
respiratory quotient in the treadmill test
Measured: Change from baseline respiratory quotient at 8 weeks
Time in running test
Time in the 3000 meters running test
Measured: Change from baseline time at 8 weeks
Lactate change
Lactate change after the 3000m test
Measured: Change from baseline Lactate at 8 weeks
Speed in running test
Speed in the 3000 meters running test
Measured: Change from baseline speed at 8 weeks
Heart rate in running test
Heart rate in the 3000 meters running test
Measured: Change from baseline heart rate at 8 weeks
Börg scale after running test
Subjective perceived exertion. Scores goes from 0 to 10. Higher scores indicate a higher perceived exertion.
Measured: Through study completion (8 weeks)
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.
Measured: Through study completion (8 weeks)
Mood score
Precompetitive mood levels. Instrument: Profile of Mood States. Scores goes from 0 (low mood) to 4 (high mood).
Measured: Through study completion (8 weeks)
Anxiety score
Precompetitive anxiety levels. Instrument: Revised Competitive State Anxiety Inventory-2. Scores goes from 1 (no anxiety) to 4 (a lot of anxiety).
Measured: Through study completion (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start7 Sep 2019
- Primary completion7 Dec 2019
- Study completion7 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Carrasco Poyatos, Universidad de Almeria
- Investigators
- Alberto González Quílez, Master, Study chair, Universidad de AlmeriaAntonio Granero-Gallegos, PhD, Principal investigator, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150952
- Sponsor's protocol ID
- UAL-HRV
- Acronym
- HRV-btA
- Status last verified
- May 2020
- First submitted
- 24 Oct 2019
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Psychological Effects of Heart Rate Variability Based Training in Endurance Athletes
- ClinicalTrials.gov ID
- NCT04150952
- Acronym / sponsor ID
- HRV-btA / UAL-HRV
- Conditions
- Heart Rate Control, Athlete, Emotions
- Keywords
- Heart rate variability, Training, Endurance, Mood, Anxiety, Stress, maximal oxygen consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 7 Sep 2019 (actual)
- Primary completion
- 7 Dec 2019 (actual)
- Study completion
- 7 Dec 2019 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRV-Group | Experimental | Other: HRV-based trainingAthletes 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. |
| TRAD-Group | Active comparator | Other: TRAD trainingAthletes will train according to their trainer plan. Training will not be guided by their basal HRV scores. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRV-based trainingIntervention based on HRV-guided training for the performance improvement of athletes. Pre-competitive HRV, subjective effort perception, anxiety and mood will also be analysed. | Other | HRV-Group |
| TRAD trainingTraditional endurance training | Other | TRAD-Group |
Primary outcome
VO2max
Time frame: Change from baseline VO2max at 8 weeks
Maximal oxygen consumption in treadmill test
12 secondary outcomes
maximal heart rate
Time frame: Change from baseline maximal heart rate at 8 weeks
maximal speed
Time frame: Change from baseline maximal speed at 8 weeks
ventilatory thresolds
Time frame: Change from baseline ventilatory thresolds at 8 weeks
respiratory quotient
Time frame: Change from baseline respiratory quotient at 8 weeks
Time in running test
Time frame: Change from baseline time at 8 weeks
Lactate change
Time frame: Change from baseline Lactate at 8 weeks
Speed in running test
Time frame: Change from baseline speed at 8 weeks
Heart rate in running test
Time frame: Change from baseline heart rate at 8 weeks
Börg scale after running test
Time frame: Through study completion (8 weeks)
LnrMSSD score
Time frame: Through study completion (8 weeks)
Mood score
Time frame: Through study completion (8 weeks)
Anxiety score
Time frame: Through study completion (8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto González Quílez, Master study chair
Universidad de Almeria
Antonio Granero-Gallegos, PhD principal investigator
Universidad de Almeria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HRV-based training and TRAD training in people with Heart Rate Control and Athlete, run by Universidad de Almeria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2max (time frame: Change from baseline VO2max at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.