Healthy VolunteersNCT06111144
Effects of Polarized and Pyramidal Training Combined With or Without Mindfulness in Amateur Runners
A study testing Polarized training intensity distribution (TID) and mental training using mindfulness, Pyramidal training intensity distribution (TID) and mental training using mindfulness and Polarized training intensity distribution (TID) without mindfulness in people with Healthy Volunteers, run by Universidad de Antioquia at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Polarized training intensity distribution (TID) and mental training using mindfulness, Pyramidal training intensity distribution (TID) and mental training using mindfulness and Polarized training intensity distribution (TID) without mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteColombia
- Study dates
- 16 Aug 2023to 15 Dec 2023
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Smokers.
- History of cardiovascular disease.
- Arrhythmias.
- Cardiac insufficiencies.
- Hypertension.
- Musculoskeletal problems that affect their participation in the training program.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Healthy Volunteers
- Being tested
- Polarized training intensity distribution (TID) and mental training using mindfulness, Pyramidal training intensity distribution (TID) and mental training using mindfulness, Polarized training intensity distribution (TID) without mindfulness, Pyramidal training intensity distribution (TID) without mindfulness
- Keywords
- Training intensity distribution, Polarized training, Pyramidal training, Amateur long-distance runners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polarized training intensity distribution (TID) and mental training using mindfulnessBehavioural
Polarized TID model group with mindfulness program (POL+)
Pyramidal training intensity distribution (TID) and mental training using mindfulnessBehavioural
Pyramidal TID model group with mindfulness program (PYR+)
Polarized training intensity distribution (TID) without mindfulnessBehavioural
Polarized TID model group without mindfulness program (POL-)
Pyramidal training intensity distribution (TID) without mindfulnessBehavioural
Pyramidal TID model group without mindfulness program (PYR-).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Behavioral: Pyramidal training intensity distribution (TID) and mental training using mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0 and 13
Secondary outcomes (7)
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.
Measured: Week 0 and 13
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.
Measured: Week 0 and 13
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).
Measured: Week 0 and 13
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.
Measured: Week 0 and 13
Change in body weight
Body weight (kg) will be obtained using a HBF-514C OMRON© body composition analyzer
Measured: Week 0 and 13
Change in body fat
Body fat (%) will be obtained using a HBF-514C OMRON© body composition analyzer
Measured: Week 0 and 13
Change in muscle mass
Muscle mass (%) will be obtained using a HBF-514C OMRON© body composition analyzer
Measured: Week 0 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start16 Aug 2023
- Primary completion24 Nov 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Hugo Arboleda Serna, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111144
- Sponsor's protocol ID
- TID-Runners-UdeA-JCRunning
- Status last verified
- Oct 2024
- First submitted
- 26 Oct 2023
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06111144
- Acronym / sponsor ID
- TID-Runners-UdeA-JCRunning
- Conditions
- Healthy Volunteers
- Keywords
- Training intensity distribution, Polarized training, Pyramidal training, Amateur long-distance runners
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 1 Nov 2023 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Polarized training Intensity distribution model without mindfulness program | Experimental | Behavioral: Polarized training intensity distribution (TID) without mindfulnessThe 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 |
| Pyramidal training Intensity distribution model without mindfulness program | Experimental | Behavioral: Pyramidal training intensity distribution (TID) without mindfulnessThe 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 |
| Polarized training Intensity distribution model with mindfulness program | Experimental | Behavioral: Polarized training intensity distribution (TID) and mental training using mindfulnessThe 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 |
| Pyramidal training Intensity distribution model with mindfulness program | Experimental | Behavioral: Pyramidal training intensity distribution (TID) and mental training using mindfulnessThe 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 |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- Smokers.
- History of cardiovascular disease.
- Arrhythmias.
- Cardiac insufficiencies.
- Hypertension.
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 |
|---|---|---|
| Polarized training intensity distribution (TID) and mental training using mindfulnessPolarized TID model group with mindfulness program (POL+) | Behavioural | Polarized training Intensity distribution model with mindfulness program |
| Pyramidal training intensity distribution (TID) and mental training using mindfulnessPyramidal TID model group with mindfulness program (PYR+) | Behavioural | Pyramidal training Intensity distribution model with mindfulness program |
| Polarized training intensity distribution (TID) without mindfulnessPolarized TID model group without mindfulness program (POL-) | Behavioural | Polarized training Intensity distribution model without mindfulness program |
| Pyramidal training intensity distribution (TID) without mindfulnessPyramidal TID model group without mindfulness program (PYR-). | Behavioural | Pyramidal training Intensity distribution model without mindfulness program |
Primary outcome
Change in 10 km race time
Time frame: Week 0 and 13
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.
7 secondary outcomes
Change in VO2max
Time frame: Week 0 and 13
Change in ventilatory threshold 1
Time frame: Week 0 and 13
Change in ventilatory threshold 2
Time frame: Week 0 and 13
Change in maximal aerobic speed
Time frame: Week 0 and 13
Change in body weight
Time frame: Week 0 and 13
Change in body fat
Time frame: Week 0 and 13
Change in muscle mass
Time frame: Week 0 and 13
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 3 Oct 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polarized training intensity distribution (TID) and mental training using mindfulness, Pyramidal training intensity distribution (TID) and mental training using mindfulness and Polarized training intensity distribution (TID) without mindfulness in people with Healthy Volunteers, run by Universidad de Antioquia at 1 site in Colombia.
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 2 inclusion and 6 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 3 Oct 2024. 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 Colombia. 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?
Change in 10 km race time (time frame: Week 0 and 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2024.