NCT07109089

Brief Summary

The goal of this randomized controlled trial is to compare adherence to training prescription-defined as the percentage of time spent within the prescribed intensity zone-using either a race pace-based method or a heart rate-based method in male and female recreational distance runners. The main research questions are:

  • Which training prescription method leads to greater adherence in recreational runners?
  • Which method results in more accurate execution of low- and high-intensity interval training sessions? Participants will undergo anthropometric and physiological assessments to determine training zones based on ventilatory thresholds. In addition, a 5-km time trial will be performed on a standard track to establish individual race pace zones.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

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

February 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 7, 2025

Last Update Submit

July 30, 2025

Conditions

Keywords

Endurance prescriptionHIITRecreational runnersExcercise monitoring

Outcome Measures

Primary Outcomes (3)

  • Maximal Oxygen Uptake (VO₂max)

    VO₂max (mL·kg-¹·min-¹) measured during an incremental treadmill test to volitional exhaustion. Respiratory gases are collected breath-by-breath using a calibrated metabolic cart. The highest 30-second average of VO₂ is taken as VO₂max.

    Baseline

  • Time in Zone - Low-Intensity Training

    Total time (in minutes and % of intended time in zone) spent within the prescribed low-intensity training zone during each session, as determined by either heart rate (below first ventilatory threshold) or race pace (based on individual 5-km performance). Training zones are predefined per method and monitored via GPS watches and heart rate monitors.

    Week 1 and week 2

  • Time in Zone - High-Intensity Interval Training (HIIT)

    Total time (in minutes and % of intended time in zone) spent within the prescribed high-intensity training zone during interval sessions, based on either heart rate (above second ventilatory threshold) or race pace (percentage of 5-km race pace). Time in zone is extracted from GPS and HR data post-session

    Week 1 and week 2

Secondary Outcomes (2)

  • Body weight (kg) and Body Mass Index (BMI kg/m²)

    Baseline

  • Ventilatory thresholds

    Baseline

Study Arms (2)

Race Pace Group

EXPERIMENTAL

Participants follow a training program based on race pace zones, including both low-intensity sessions and high-intensity intervals.

Other: Race Pace-based training

Heart Rate Group

EXPERIMENTAL

Participants follow a training program based on heart rate zones, including both low-intensity sessions and high-intensity intervals.

Other: Heart Rate-Based Training

Interventions

Participants complete one week of endurance training based on race pace zones individually determined from a 5-km time trial performance. The program includes both low-intensity continuous runs and high-intensity interval training sessions.

Race Pace Group

Participants complete one week of endurance training based on heart rate zones individually determined from ventilatory threshold assessments. The program includes both low-intensity continuous runs and high-intensity interval training sessions.

Heart Rate Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male and female recreational endurance runners
  • minimum of four training sessions per week
  • at least three of consistent endurance training experience

You may not qualify if:

  • current smokers
  • diagnosed metabolic disorders
  • any cardiovascular, pulmonary, or orthopedic condition that may interfere with exercise performance or safety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cam. del Molino, 5, Fuenlabrada, Madrid

Fuenlabrada, Madrid, 28943, Spain

Location

Related Publications (1)

  • 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.

    PMID: 39935030BACKGROUND

Study Officials

  • Arturo Casado, PhD

    Universidad Rey Juan Carlos

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 7, 2025

First Posted

August 7, 2025

Study Start

February 1, 2024

Primary Completion

July 30, 2024

Study Completion

January 30, 2025

Last Updated

August 7, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations