NCT06111144

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable healthy-volunteers

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

August 16, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 26, 2023

Last Update Submit

October 1, 2024

Conditions

Keywords

Training intensity distributionPolarized trainingPyramidal trainingAmateur long-distance runners

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change in VO2max

    Week 0 and 13

  • Change in ventilatory threshold 1

    Week 0 and 13

  • Change in ventilatory threshold 2

    Week 0 and 13

  • Change in maximal aerobic speed

    Week 0 and 13

  • Change in body weight

    Week 0 and 13

  • +2 more secondary outcomes

Study Arms (4)

Polarized training Intensity distribution model without mindfulness program

EXPERIMENTAL

The TID of the entire training program will be zone 1 (80%), zone 2 (5%), zone 3 (15%). The periodization of the training will be performed in a 3:1 load-recovery cycle, that is, three weeks of load for one week of recovery, this cycle will be repeated 3 times to complete the 12 weeks. The running sessions will have a volume in the load weeks as follows: The first week a volume of 5 hours, the second week 5.5 hours and the third week 6 hours. In the recovery week the volume will be 4 hours. As for the running technique and strength, these will have a weekly volume of 30 min and 1 hour respectively during all 12 weeks. In summary: 60 running sessions 24 strength sessions 24 running technique sessions

Behavioral: Polarized training intensity distribution (TID) without mindfulness

Pyramidal training Intensity distribution model without mindfulness program

EXPERIMENTAL

The TID of the entire training program will be zone 1 (80%), zone 2 (5%), zone 3 (15%). The periodization of the training will be performed in a 3:1 load-recovery cycle, that is, three weeks of load for one week of recovery, this cycle will be repeated 3 times to complete the 12 weeks. The running sessions will have a volume in the load weeks as follows: The first week a volume of 5 hours, the second week 5.5 hours and the third week 6 hours. In the recovery week the volume will be 4 hours. As for the running technique and strength, these will have a weekly volume of 30 min and 1 hour respectively during all 12 weeks. In summary: 60 running sessions 24 strength sessions 24 running technique sessions

Behavioral: Pyramidal training intensity distribution (TID) without mindfulness

Polarized training Intensity distribution model with mindfulness program

EXPERIMENTAL

The TID of the entire training program will be zone 1 (80%), zone 2 (5%), zone 3 (15%). The periodization of the training will be performed in a 3:1 load-recovery cycle, that is, three weeks of load for one week of recovery, this cycle will be repeated 3 times to complete the 12 weeks. The running sessions will have a volume in the load weeks as follows: The first week a volume of 5 hours, the second week 5.5 hours and the third week 6 hours. In the recovery week the volume will be 4 hours. As for the running technique, strength and mindfulness these will have a weekly volume of 30 min, 1 hour and 65 min respectively during all 12 weeks. The weekly mindfulness practice will be done in 4 different types of sessions: (life-meditation, jogging-meditation, stretching-meditation, running-meditation). In summary: 60 running sessions 60 mindfulness sessions 24 strength sessions 24 running technique sessions

Behavioral: Polarized training intensity distribution (TID) and mental training using mindfulness

Pyramidal training Intensity distribution model with mindfulness program

EXPERIMENTAL

The TID of the entire training program will be zone 1 (80%), zone 2 (15%), zone 3 (5%). The periodization of the training will be performed in a 3:1 load-recovery cycle, that is, three weeks of load for one week of recovery, this cycle will be repeated 3 times to complete the 12 weeks. The running sessions will have a volume in the load weeks as follows: The first week a volume of 5 hours, the second week 5.5 hours and the third week 6 hours. In the recovery week the volume will be 4 hours. As for the running technique, strength and mindfulness these will have a weekly volume of 30 min, 1 hour and 65 min respectively during all 12 weeks. The weekly mindfulness practice will be done in 4 different types of sessions: (life-meditation, jogging-meditation, stretching-meditation, running-meditation). In summary: 60 running sessions 60 mindfulness sessions 24 strength sessions 24 running technique sessions

Behavioral: Pyramidal training intensity distribution (TID) and mental training using mindfulness

Interventions

Polarized TID model group with mindfulness program (POL+)

Polarized training Intensity distribution model with mindfulness program

Pyramidal TID model group with mindfulness program (PYR+)

Pyramidal training Intensity distribution model with mindfulness program

Polarized TID model group without mindfulness program (POL-)

Polarized training Intensity distribution model without mindfulness program

Pyramidal TID model group without mindfulness program (PYR-).

Pyramidal training Intensity distribution model without mindfulness program

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Smokers.
  • History of cardiovascular disease.
  • Arrhythmias.
  • Cardiac insufficiencies.
  • Hypertension.
  • Musculoskeletal problems that affect their participation in the training program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JC Running

Bogotá, Cundinamarca, Colombia

Location

Study Design

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

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 1, 2023

Study Start

August 16, 2023

Primary Completion

November 24, 2023

Study Completion

December 15, 2023

Last Updated

October 3, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations