Effects of Polarized and Pyramidal Training Combined With or Without Mindfulness in Amateur Runners

Healthy Volunteers Clinical Trial

Official title:

Effects of Polarized and Pyramidal Training Models Combined With or Without Mindfulness on Running Time, Performance Variables, and Body Composition in Amateur Long-distance Runners. A Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06111144
• Other study ID #: TID-Runners-UdeA-JCRunning
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Healthy Volunteers

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