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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06111144
Other study ID # TID-Runners-UdeA-JCRunning
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date August 16, 2023
Est. completion date December 15, 2023

Study information

Verified date October 2023
Source Universidad de Antioquia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Road running in athletics has grown worldwide in recent years, which has led to an increase in the number of recreational runners. Despite this growth, research addressing this population is scarce, with major limitations and methodological weaknesses. Two of the topics of recent interest in runners are the effects of training intensity distribution (TID) and mental training using mindfulness on running time, body composition and physiological parameters related to performance in endurance sports; the maximal oxygen consumption (VO2max), maximal aerobic speed (MAS) and ventilatory thresholds (VT). The scarce evidence found identifies the TID polarized model as the most effective in sports performance and TID pyramidal model as the most used by elite runners. For mindfulness, it is identified as an emerging program that could contribute to performance in endurance sports.


Description:

40 recreational long-distance runners will be randomly assigned into one of the following 4 TID models groups: polarized TID model group with mindfulness program (POL+), polarized TID model group without mindfulness program (POL-), pyramidal TID model group with mindfulness program (PYR+) and pyramidal TID model group without mindfulness program (PYR-). Each group will be composed of 10 subjects. The interventions will have a duration of 12 weeks. All participants will have evaluation of 10 km running time, body composition and physiological parameters (VO2max, MAS and VT's 1 and 2) at week 0 and 13 of the study.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 40
Est. completion date December 15, 2023
Est. primary completion date November 24, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 50 Years
Eligibility Inclusion Criteria: - Amateur long-distance runners - Running time of 10 km in Bogotá, Colombia or similar altitude (2600 m above sea level) for men between 45 and 60 minutes, and for women between 50 and 65 minutes. Exclusion Criteria: - Smokers. - History of cardiovascular disease. - Arrhythmias. - Cardiac insufficiencies. - Hypertension. - Musculoskeletal problems that affect their participation in the training program.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Polarized training intensity distribution (TID) and mental training using mindfulness
Polarized TID model group with mindfulness program (POL+)
Pyramidal training intensity distribution (TID) and mental training using mindfulness
Pyramidal TID model group with mindfulness program (PYR+)
Polarized training intensity distribution (TID) without mindfulness
Polarized TID model group without mindfulness program (POL-)
Pyramidal training intensity distribution (TID) without mindfulness
Pyramidal TID model group without mindfulness program (PYR-).

Locations

Country Name City State
Colombia JC Running Bogotá Cundinamarca

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in 10 km race time The time in the 10 km will be taken by two evaluators with independent stopwatches, and the average of them will be taken as the official time. The test will take place in a 1257 m loop, with a positive difference in altitude of 5 m. Week 0 and 13
Secondary Change in VO2max Incremental test to exhaustion on a Woodway© model 4Front treadmill. During the test, VO2 will be measured breath-by-breath by a portable metabolic system COSMED© model K5.
The VO2max will be calculated as the average oxygen consumption of the last 30 seconds measured in the incremental test.
Week 0 and 13
Secondary Change in ventilatory threshold 1 Incremental test to exhaustion on a Woodway© model 4Front treadmill. During the test, ventilatory threshold 1 will be measured by a portable metabolic system COSMED© model K5.
Ventilatory threshold 1 will be defined as the first increase in ventilatory equivalent for oxygen (VE/VO2) vs. load, without a simultaneous increase in ventilatory equivalent for carbon dioxide (VE/VCO2) vs. load.
Week 0 and 13
Secondary Change in ventilatory threshold 2 Incremental test to exhaustion on a Woodway© model 4Front treadmill. During the test, ventilatory threshold 2 will be measured by a portable metabolic system COSMED© model K5.
Ventilatory threshold 2 will be defined as the second increase in ventilation with a concomitant rapid increase in VE/VO2 and VE/VCO2 and a decrease in the partial pressure of exhaled carbon dioxide (PETCO2).
Week 0 and 13
Secondary Change in maximal aerobic speed Incremental test to exhaustion on a Woodway© model 4Front treadmill. During the test, maximal aerobic speed will be measured by a portable metabolic system COSMED© model K5.
The maximal aerobic speed will be determined at the speed corresponding to the VO2max.
Week 0 and 13
Secondary Change in body weight Body weight (kg) will be obtained using a HBF-514C OMRON© body composition analyzer Week 0 and 13
Secondary Change in body fat Body fat (%) will be obtained using a HBF-514C OMRON© body composition analyzer Week 0 and 13
Secondary Change in muscle mass Muscle mass (%) will be obtained using a HBF-514C OMRON© body composition analyzer Week 0 and 13
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