NCT06216314

Brief 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)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

December 21, 2023

Last Update Submit

January 10, 2024

Conditions

Keywords

heart rate variabilityendurance trainingHRV-guidedperiodizationtraining intensity distribution

Outcome Measures

Primary Outcomes (8)

  • 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

    Baseline and after 6 weeks

  • 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

    Baseline and after 6 weeks

  • 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

    Baseline and after 6 weeks

  • 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

    Baseline and after 6 weeks

  • 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

    Baseline and after 6 weeks

  • 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

    Baseline and after 6 weeks

  • 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

    Baseline and after 6 weeks

  • 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

    Baseline and after 6 weeks

Secondary Outcomes (6)

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

    Baseline and after 6 weeks

  • Changes in Body Weight

    Baseline and after 6 weeks

  • Changes in Height (cm)

    Baseline and after 6 weeks

  • Changes in BMI (kg/m^2)

    Baseline and after 6 weeks

  • Changes in Fat mass

    Baseline and after 6 weeks

  • +1 more secondary outcomes

Study Arms (3)

Heart rate (HR)

ACTIVE COMPARATOR

Three 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.

Other: Heart rate (HR)

Race pace based approach (RP)

EXPERIMENTAL

For 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.

Other: Race pace based approach (RP)

Heart rate + heart rate variability (HRV)

EXPERIMENTAL

The 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.

Other: Heart rate + heart rate variability (HRV)

Interventions

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.

Also known as: HR
Heart rate (HR)

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

Also known as: RP
Race pace based approach (RP)

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.

Also known as: HR+HRV
Heart rate + heart rate variability (HRV)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Rey Juan Carlos

Fuenlabrada, Madrid, 28943, Spain

Location

Related Publications (2)

  • 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.

    PMID: 32751204BACKGROUND
  • 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.

MeSH Terms

Interventions

Heart Rate

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Arturo Casado, PhD

    Centro de Investigación en Ciencias del Deporte

    PRINCIPAL INVESTIGATOR
  • Alfonso Jiménez Gutiérrez, PhD

    Director del Centro de Investigación en Ciencias del Deporte

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 21, 2023

First Posted

January 22, 2024

Study Start

April 20, 2023

Primary Completion

June 30, 2023

Study Completion

July 15, 2023

Last Updated

January 22, 2024

Record last verified: 2024-01

Locations