Exercise ResponseNCT07109089
Heart Rate Vs. Race Pace-Based Prescription Training in Recreational Distance Runners
A study testing Race Pace-based training and Heart Rate-Based Training in people with Exercise Response and Physical Fitness, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Response, Physical Fitness, Athletic Performance
- What is being tested?
- Race Pace-based training and Heart Rate-Based Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2024to 30 Jan 2025
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male and female recreational endurance runners
- minimum of four training sessions per week
- at least three of consistent endurance training experience
Who cannot join
- current smokers
- diagnosed metabolic disorders
- any cardiovascular, pulmonary, or orthopedic condition that may interfere with exercise performance or safety
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heart Rate Vs. Race Pace-Based Prescription Training: Which Training Method Leads To Intended Execution In Recreational Distance Runners?
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:
Read more
- 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.
- Being tested
- Race Pace-based training, Heart Rate-Based Training
- Keywords
- Endurance prescription, HIIT, Recreational runners, Excercise monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Race Pace-based trainingOther
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.
Heart Rate-Based TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Race Pace Group | Experimental | Participants follow a training program based on race pace zones, including both low-intensity sessions and high-intensity intervals. Receives: 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. Receives: Other: Heart Rate-Based Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Week 1 and week 2
Secondary outcomes (2)
Body weight (kg) and Body Mass Index (BMI kg/m²)
These variables will be assessed to monitor changes in general health status and body composition throughout the intervention.
Weight and height will be measured using a calibrated bio-electrical impedance analyzer (Tanita MC-780), with an accuracy of ±0.1 kg. Participants will be assessed barefoot, wearing light clothing, after an overnight fast and after voiding. Weight will be recorded in kilograms (kg) and height in meters (m), and BMI will be subsequently calculated as weight divided by height squared (kg/m²).
No additional outcome measures will be collected in this assessment session.
Measured: Baseline
Ventilatory thresholds
Oxygen uptake (VO₂, mL·kg-¹·min-¹) at the first and second ventilatory thresholds measured during an incremental treadmill test. Ventilatory thresholds are determined using standard gas exchange methods (e.g., V-slope, ventilatory equivalents).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Feb 2024
- Primary completion30 Jul 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise ResponseStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arturo Casado, Universidad Rey Juan Carlos
- Investigators
- Arturo Casado, PhD, Study director, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109089
- Sponsor's protocol ID
- IND/22HUM-23661
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Vs. Race Pace-Based Prescription Training: Which Training Method Leads To Intended Execution In Recreational Distance Runners?
- ClinicalTrials.gov ID
- NCT07109089
- Acronym / sponsor ID
- IND/22HUM-23661
- Keywords
- Endurance prescription, HIIT, Recreational runners, Excercise monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 7 Aug 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Race Pace Group | Experimental | Other: Race Pace-based trainingParticipants follow a training program based on race pace zones, including both low-intensity sessions and high-intensity intervals. |
| Heart Rate Group | Experimental | Other: Heart Rate-Based TrainingParticipants follow a training program based on heart rate zones, including both low-intensity sessions and high-intensity intervals. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy male and female recreational endurance runners
- minimum of four training sessions per week
- at least three of consistent endurance training experience
Key exclusion criteria (3 listed)
- current smokers
- diagnosed metabolic disorders
- any cardiovascular, pulmonary, or orthopedic condition that may interfere with exercise performance or safety
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 |
|---|---|---|
| Race Pace-based trainingParticipants 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. | Other | Race Pace Group |
| Heart Rate-Based TrainingParticipants 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. | Other | Heart Rate Group |
Primary outcome
Maximal Oxygen Uptake (VO₂max)
Time frame: Baseline
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.
Time in Zone - Low-Intensity Training
Time frame: Week 1 and week 2
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.
Time in Zone - High-Intensity Interval Training (HIIT)
Time frame: Week 1 and week 2
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
2 secondary outcomes
Body weight (kg) and Body Mass Index (BMI kg/m²)
Time frame: Baseline
Ventilatory thresholds
Time frame: Baseline
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 7 Aug 2025.
- Background: PubMed 39935030Ranieri 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.
- 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.
Arturo Casado, PhD study director
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Race Pace-based training and Heart Rate-Based Training in people with Exercise Response and Physical Fitness, 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 3 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 7 Aug 2025. 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?
Maximal Oxygen Uptake (VO₂max) (time frame: Baseline). The study lists 3 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 NCT07109089, which also lists 1 linked publication.
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 7 Aug 2025.