Clinical trial NCT06216314: Effects of Race Pace Based Approach in Recreational Runners
Official title: Effects of Race Pace Based Approach on the Performance of Recreational Runners: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: heart rate variability
endurance training
HRV-guided
periodization
training intensity distribution
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
Collaborators: name: GO fit Lab- Ingesport
First posted: 2024-01-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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)

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change from Baseline of Running Economy
timeFrame: Baseline and after 6 weeks
measure: Change from Baseline of VO2max
timeFrame: Baseline and after 6 weeks
measure: Change from Baseline of Maximum aerobic velocity (VAM)
timeFrame: Baseline and after 6 weeks
measure: Change from Baseline of 7-km Time Trial Performance
timeFrame: Baseline and after 6 weeks
measure: Change from Baseline of the First Physiological Thresholds (VT1)
timeFrame: Baseline and after 6 weeks
measure: Change from Baseline of the second Physiological Thresholds (VT2)
timeFrame: Baseline and after 6 weeks
measure: Change from baseline in HR associated with the first ventilatory threshold
timeFrame: Baseline and after 6 weeks
measure: Change from baseline in HR associated with the second ventilatory threshold
timeFrame: Baseline and after 6 weeks
Secondary outcomes:
measure: Change of Rate of Perceived Exertion (RPE) scale after 6 weeks protocol
timeFrame: Baseline and after 6 weeks
measure: Changes in Body Weight
timeFrame: Baseline and after 6 weeks
measure: Changes in Height (cm)
timeFrame: Baseline and after 6 weeks
measure: Changes in BMI (kg/m^2)
timeFrame: Baseline and after 6 weeks
measure: Changes in Fat mass
timeFrame: Baseline and after 6 weeks
measure: Changes in Free Fat Mass
timeFrame: Baseline and after 6 weeks
Other outcomes:
Locations:
city: Fuenlabrada
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Centro de Investigación en Ciencias del Deporte
name: Arturo Casado, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Director del Centro de Investigación en Ciencias del Deporte
name: Alfonso Jiménez Gutiérrez, PhD
role: STUDY_DIRECTOR
References:
citation: 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.