AzTrials
AzTrials

Healthy22HUM23661NCT06216314

Effects of Race Pace Based Approach in Recreational Runners

A study testing Heart rate (HR), Race pace based approach (RP) and Heart rate + heart rate variability (HRV) in people with Healthy, run by Universidad Rey Juan Carlos at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of the study was to compare the performance effects of the intensity demarcation model based on the race pace based approach with the triphasic physiological model and heart rate variability guidelines (HR+HRV) Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Heart rate (HR), Race pace based approach (RP) and Heart rate + heart rate variability (HRV)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteSpain
Study dates
20 Apr 2023to 15 Jul 2023
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Being adults
  • VO2max between 45 and 60 mL·min-1·kg^-1 for men
  • VO2max between 40 and 55 mL·min^-1 for women
  • More than 4 days per week of training frequency
  • Running experience ≥ 2 years
  • Record HR data of all training sessions during the study

Who cannot join

  • Previous injuries for at least three months
  • Smokers
  • Any cardiovascular condition that compromises health status and participation in the study

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universidad Rey Juan Carlos

    Fuenlabrada, Madrid, 28943

Other trials in Spain

About this study

Official title: Effects of Race Pace Based Approach on the Performance of Recreational Runners: a Randomized Controlled Trial

The aim of the study was to compare the performance effects of the intensity demarcation model based on the race pace based approach with the triphasic physiological model and heart rate variability guidelines (HR+HRV)

Read the detailed description

After being informed and signing informed consent about the present study, participants were randomly assigned to one of three groups before the intervention phase using a Web-based computer program (www.randomizer.org). Groups were matched on a 1:1:1 basis by gender, age, and performance in an official 10-km race in the previous month. Once selected, participants in the heart rate variability (HRV) group began daily measurements to obtain their personalized parameters.

The groups changed according to the intensity zone demarcation pattern: heart rate (HR), race pace (RP) and HR+HRV. The HR group was considered the active control group, as considered the current best practice according to the current literature in endurance running. A 4-week pre-intervention plus 6-week intervention program was set up.

Participants were assessed in four different sessions, two for laboratory evaluations and two for time trial performance. The first session consisted of a running economy test, and, after at least half an hour of rest, a maximal incremental treadmill run. They familiarised themselves with the training sessions according to their group (i.e., running based on HR, RP or HR+HRV guidelines, respectively).

The HRV4training mobile application (https://www.hrv4training.com) was used to assess HRV for one minute in the morning. The difference in RR intervals between heartbeats is used to calculate HRV. The program then uses this information to calculate the rMSSD and moving average (LnrMSSD7-d), converting the results to a number between 5 and 10. Then, the participant must answer a series of questions including his or her current physical state, sleep quality, muscle soreness, etc. After interpolating these variables, the application shows the subjective value derived from the body's reaction to stresses. As a result, daily indications are given in numerical form, with a range of normality (for HR and HRV) that varies each day depending on how the person reacts to stress. Participants were instructed to take the measurement as soon as they woke up, with an empty bladder, lying down, trying to limit movement, and breathing naturally

Training variables (total time, distance, total time spent in each zone) and Training Impulse (TRIMP) were the same for all groups

Conditions
Healthy
Being tested
Heart rate (HR), Race pace based approach (RP), Heart rate + heart rate variability (HRV)
Keywords
heart rate variability, endurance training, HRV-guided, periodization, training intensity distribution

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heart rate (HR)Other

    Also called HR

    Runners ran according to speeds and HR associated with ventilatory thresholds. Z1, zone 1: intensity zone below the first ventilatory threshold; Z2: zone 2, intensity zone between the first and second ventilatory threshold; Z3: zone 3, intensity zone above the second ventilatory threshold.

  • Race pace based approach (RP)Other

    Also called RP

    Runners ran respecting three intensity zones.

    The average speed achieved in the 7-km was calculated. From this, three intensity zones were calculated, adhering to the % of the race pace of the 7-km test.

    Z1 corresponds to less than 80% of race pace, Z2 is between 80-95%, and Z3 corresponds to over 95% of race pace

  • Heart rate + heart rate variability (HRV)Other

    Also called HR+HRV

    Runners completed training sessions based on HR values and velocities associated with ventilatory thresholds (i.e., Z1, zone 1: intensity zone below the first ventilatory threshold; Z2: zone 2, intensity zone between the first and second ventilatory threshold; Z3: zone 3, intensity zone above the second ventilatory threshold. The training sessions were based on physiological thresholds and daily HRV cues. High-intensity training was performed only under optimal HRV conditions, thus only when each participant had HRV values in their reference range. If HRV was not optimal, low-intensity training was prescribed. If HRV was not optimal for two days consecutively, rest was prescribed.

Study groups in NCT06216314
Study groupRoleWhat they receive
Heart rate (HR)Active comparatorThree physiological zones were established according to the results of the treadmill test. The HR group completed training sessions based on HR values and velocities associated with ventilatory thresholds (i.e., Z1, zone 1: intensity zone below the first ventilatory threshold; Z2: zone 2, intensity zone between the first and second ventilatory threshold; Z3: zone 3, intensity zone above the second ventilatory threshold. Runners trained 4 times a week.
Receives: Other: Heart rate (HR)
Race pace based approach (RP)ExperimentalFor the race pace based approach (RP), intensity zones were established by calculating the percentage of the average speed achieved in the 7-km time trial (TT) and 3 zones were established. Kenneally's model was used to determine the race intensity zones by analyzing 7-km TT performance. Z1 corresponds to less than 80% of race pace, Z2 is between 80-95%, and Z3 corresponds to over 95% of race pace. Runners trained 4 times a week.
Receives: Other: Race pace based approach (RP)
Heart rate + heart rate variability (HRV)ExperimentalThe HR+HRV group completed training sessions based on HR values and velocities associated with ventilatory thresholds (i.e., Z1, zone 1: intensity zone below the first ventilatory threshold; Z2: zone 2, intensity zone between the first and second ventilatory threshold; Z3: zone 3, intensity zone above the second ventilatory threshold. The training sessions were based on physiological thresholds and daily HRV cues. Runners trained 4 times a week.
Receives: Other: Heart rate + heart rate variability (HRV)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline of Running Economy

    Tests were performed on the treadmill and respiratory gas analysis was carried out.

    The laboratory tests included:

    • Running economy (RE) test (ml·kg·km)

    RE was measured by running two blocks at constant speeds (7 and 9 km·h^-1 or 8 and 10 km·h^-1, respectively), depending on the subject's level, intensities below the first ventilatory threshold. Each block lasted three minutes.

    RE is one of the physiological determinants of endurance performance: an improvement in RE over time indicates an improvement in performance

    Measured: Baseline and after 6 weeks

  2. Change from Baseline of VO2max

    Tests were performed on the treadmill and respiratory gas analysis was carried out.

    The laboratory tests included:

    • Maximum oxygen consumption test (VO2max)

    After 30 minutes of rest, a maximal incremental test was performed to calculate relative VO2max (ml·kg^-1·min^-1) and absolute VO2max (L·min^-1).

    The test started at the last speed of the RE test (9 or 10 km·h^-1), depending on the subject's level. The speed increased continuously by 0.5 km·h-1 every minute until exhaustion. The mean value of the last 30 s of the VO2, a respiratory exchange ratio (RER) >1.05, a HR > 95% of the maximum HR, and an RPE > 18 were the variables considered to calculate the VO2max

    VO2max is one of the determinants of endurance performance. The relative VO2max is influenced by weight (at equal VO2max, the runner who weighs less is more advantaged). An improvement in absolute and relative values of VO2max over time indicate an improvement in performance

    Measured: Baseline and after 6 weeks

  3. Change from Baseline of Maximum aerobic velocity (VAM)

    Tests were performed on the treadmill and respiratory gas analysis was carried out.

    The laboratory tests included:

    • Maximum aerobic velocity (VAM) in km·h^-1

    VAM was calculated as the minimum speed that elicits maximum oxygen consumption.

    VAM is one of the physiological determinants of endurance performance. An increase in VAM velocity over time is an indication of improved performance

    Measured: Baseline and after 6 weeks

  4. Change from Baseline of 7-km Time Trial Performance

    Before and after 6 weeks, the final time achieved in a 7-km time trial performance was calculated for all participants.

    The athletes were instructed to achieve their best performance on the 7-km. The test was performed in a 400m regulation athletic track. Verbal encouragement was given to all runners in both tests every 400-m lap.

    Participants used the same shoe model in the two tests and were asked not to use stimulants (coffee, tea, etc.). They performed the tests at the same time of day ± (2 hours).

    A decrease in the final time in the second test, indicates an improvement in performance

    Measured: Baseline and after 6 weeks

  5. Change from Baseline of the First Physiological Thresholds (VT1)

    Ventilatory thresholds (VT1 and VT2), measured by gas analysis, are some of the determinants of endurance performance, along with running economy and VO2max.

    Were measured changes in:

    • Velocity associated with the first ventilatory threshold (VT1) in km·h^-1

    Velocity zones corresponding to VT1 indicates a low intensity zone. An increase over time in VT1 indicates an improvement of the aerobic system

    Measured: Baseline and after 6 weeks

  6. Change from Baseline of the second Physiological Thresholds (VT2)

    Ventilatory thresholds (VT), measured by gas analysis, are some of the determinants of endurance performance, along with running economy and VO2max.

    Were measured changes in:

    • Velocity associated with the second ventilatory threshold (VT2) in km·h^-1.

    Intensity zones corresponding to VT2 indicates a high intensity zone. An increase over time in VT2 indicates an improvement in the anaerobic system

    Measured: Baseline and after 6 weeks

  7. Change from baseline in HR associated with the first ventilatory threshold

    Ventilatory thresholds (VT), measured by gas analysis, are some of the determinants of endurance performance, along with running economy and VO2max.

    were measured changes in:

    • HR associated with the first ventilatory threshold HR-VT1 in beats per minute (bpm).

    A lower HR associated with VT1, indicates an improvement of the aerobic system over time

    Measured: Baseline and after 6 weeks

  8. Change from baseline in HR associated with the second ventilatory threshold

    Ventilatory thresholds (VT), measured by gas analysis, are some of the determinants of endurance performance, along with running economy and VO2max.

    were measured changes in:

    • HR associated with the second ventilatory threshold (HR-VT12) in beats per minute (bpm).

    Higher HR associated with VT2, indicates an improvement of the anaerobic system over time

    Measured: Baseline and after 6 weeks

Secondary outcomes (6)

  1. Change of Rate of Perceived Exertion (RPE) scale after 6 weeks protocol

    Participants indicated Rating of perceived exertion (RPE) using Borg's 6-20 validated scale, an exertion perception scale used during laboratory testing. RPE values were measured for both the running economy and during the incremental maximal test (VO2max).

    The RPE values are:

    1. = no exertion at all 7. = extremely light 9. = very light 11. = light 13. = somewhat hard 15. = hard (heavy) 17. = very hard 19. = extremely hard A decrease in RPE over time for the same intensity (e.g., same speed achieved in tests) indicates better performance adaptation

    Measured: Baseline and after 6 weeks

  2. Changes in Body Weight

    Participants were weighed before and after the study to calculate body composition analysis. Participants arrived well hydrated, and were instructed to eat at least two hours beforehand. Weighing was performed at the same time slot (± 2 hours).

    it was measured:

    • Body weight (kg)

    Measured: Baseline and after 6 weeks

  3. Changes in Height (cm)

    Participants were weighed before and after the study to calculate body composition analysis.

    Participants arrived well hydrated, and were instructed to eat at least two hours beforehand. Weighing was performed at the same time slot (± 2 hours).

    it was measured:

    • Height (cm)

    Measured: Baseline and after 6 weeks

  4. Changes in BMI (kg/m^2)

    Participants were weighed before and after the study to calculate body composition analysis:

    Participants arrived well hydrated, and were instructed to eat at least two hours beforehand. Weighing was performed at the same time slot (± 2 hours).

    it was measured:

    • BMI (kg/m^2)

    Measured: Baseline and after 6 weeks

  5. Changes in Fat mass

    Participants were weighed before and after the study to calculate body composition analysis:

    Participants arrived well hydrated, and were instructed to eat at least two hours beforehand. Weighing was performed at the same time slot (± 2 hours).

    it was measured:

    • Fat mass (%)

    Measured: Baseline and after 6 weeks

  6. Changes in Free Fat Mass

    Participants were weighed before and after the study to calculate body composition analysis:

    Participants arrived well hydrated, and were instructed to eat at least two hours beforehand. Weighing was performed at the same time slot (± 2 hours).

    it was measured:

    • Free fat mass (%)

    Measured: Baseline and after 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2024
  2. Study start20 Apr 2023
  3. Primary completion30 Jun 2023
  4. Study completion15 Jul 2023

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
A 4-week pre-intervention plus 6-week intervention program was set up. Participants were randomly assigned to one of the three groups before the intervention phase using a web-based computer program (www.randomizer.org). A randomized controlled trial with three-armed parallel group was set.
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06216314
Sponsor's protocol ID
1201202302023
Other IDs
22HUM-23661
Acronym
22HUM23661
Status last verified
Jan 2024
First submitted
21 Dec 2023
Last updated
22 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Carrasco-Poyatos M, Gonzalez-Quilez A, Martinez-Gonzalez-Moro I, Granero-Gallegos A. HRV-Guided Training for Professional Endurance Athletes: A Protocol for a Cluster-Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Jul 29;17(15):5465. doi: 10.3390/ijerph17155465.

    PubMed 32751204

  • Ranieri LE, Casado A, Martin D, Trujillo-Colmena D, Gil-Arias A, Kenneally M, Jimenez A. Performance and Physiological Effects of Race Pace-Based Versus Heart Rate Variability-Guided Training Prescription in Runners. Med Sci Sports Exerc. 2025 Jul 1;57(7):1510-1522. doi: 10.1249/MSS.0000000000003671. Epub 2025 Feb 12.

    PubMed 39935030

Questions about this trial

What is this clinical trial studying?

A study testing Heart rate (HR), Race pace based approach (RP) and Heart rate + heart rate variability (HRV) in people with Healthy, run by Universidad Rey Juan Carlos 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 6 inclusion and 3 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 22 Jan 2024. 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?

Change from Baseline of Running Economy (time frame: Baseline and after 6 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06216314, which also lists 2 linked publications.

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 22 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in