HealthyRunningNCT02498873
Linear Running Periodization x Nonlinear
A study testing Linear Periodization and Non Linear Periodization in people with Healthy, run by Universidade Federal do Rio de Janeiro.
Trial summary
In a competitive scenario, trainers and coaches seek to improve the performance of their athletes organizing macrocycles (year), mesocycles (months), and microcycles (weeks) training aimed at a specific moment of a competition. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Linear Periodization and Non Linear Periodization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jan 2016
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Minimum standards of physical activity proposed by the ACSM
- 18-45 years
- No metabolic or cardiovascular events
- No use ergogenic resources
Who cannot join
- Sedentary
- Diagnosis of cardiac, pulmonary or diabetes type I or II
- No injuries
About this study
Official title: Linear Running Periodization x Nonlinear: a Cross Effect of Five Months Controlled Running on VO2Max and Critical Power Performance
In a competitive scenario, trainers and coaches seek to improve the performance of their athletes organizing macrocycles (year), mesocycles (months), and microcycles (weeks) training aimed at a specific moment of a competition. The organization variables, mainly the intensity of exercise in a training routine can stimulate important physiological pathways and uphold superior gains to VO2max, leading to a peak aerobic performance. However, due to lack of evidence, and the difficulty of control on a large scale, the effects of the intensity organization over a mesocycle periodization are still poorly investigated.
Read the detailed description
The objective of this study is compare two intensity blocks organization a) linear progression intensity (LP) and b) randomized or not intensity linaer (NLP) over five months running training, and a crossover design between subjects, on gains in VO2max, peak velocity (Vpeak) and critical power (CP). Furthermore, the relationship between the gains obtained with the training and the amount of exercise will be established. In our case all dependent variables will increase after training, with no significant differences between the two strategies on dependent variables.
- Conditions
- Healthy
- Being tested
- Linear Periodization, Non Linear Periodization
- Keywords
- VO2Max, Physical Conditioning, Aerobic Exercise, Performance
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linear PeriodizationBehavioural
Also called LP, Progressive Periodization
Linear Intensity Periodization Running
Non Linear PeriodizationBehavioural
Also called NLP, Randomized Intensity
Non Linear Periodization Running
| Study group | Role | What they receive |
|---|---|---|
| Linear Periodization | Active comparator | Linear Periodization Running (Crossover Design) Receives: Behavioral: Non Linear Periodization |
| Non Linear Periodization | Active comparator | Non Linear Periodization Running (Crossover Design) Receives: Behavioral: Linear Periodization |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2Max
Observe the improvement of VO2max
Measured: 0 - 2 month; 1 month (wash out); 3 - 5 month
Secondary outcomes (2)
Critical Power
Performance of Critical Power in Linear Periodization and Non Linear Periodization
Measured: 0 - 2 month; 1 month (wash out); 3 - 5 month
Peak Velocity
Performance of Vpeak in Progressive Effort Test
Measured: 0 - 2 month; 1 month (wash out); 3 - 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Souza de Sá Filho, Universidade Federal do Rio de Janeiro
- Investigators
- Sérgio Machado, PhD, Study director, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498873
- Sponsor's protocol ID
- UNIVERSO-01
- Acronym
- Running
- Status last verified
- Jan 2016
- First submitted
- 11 Jul 2015
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linear Running Periodization x Nonlinear: a Cross Effect of Five Months Controlled Running on VO2Max and Critical Power Performance
- ClinicalTrials.gov ID
- NCT02498873
- Acronym / sponsor ID
- Running / UNIVERSO-01
- Conditions
- Healthy
- Keywords
- VO2Max, Physical Conditioning, Aerobic Exercise, Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 15 Jul 2015 (estimated)
- 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.
In a competitive scenario, trainers and coaches seek to improve the performance of their athletes organizing macrocycles (year), mesocycles (months), and microcycles (weeks) training aimed at a specific moment of a competition. The organization variables, mainly the intensity of exercise in a training routine can stimulate important physiological pathways and uphold superior gains to VO2max, leading to a peak aerobic performance. However, due to lack of evidence, and the difficulty of control on a large scale, the effects of the intensity organization over a mesocycle periodization are still poorly investigated.
Detailed description
The objective of this study is compare two intensity blocks organization a) linear progression intensity (LP) and b) randomized or not intensity linaer (NLP) over five months running training, and a crossover design between subjects, on gains in VO2max, peak velocity (Vpeak) and critical power (CP). Furthermore, the relationship between the gains obtained with the training and the amount of exercise will be established. In our case all dependent variables will increase after training, with no significant differences between the two strategies on dependent variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linear Periodization | Active comparator | Behavioral: Non Linear PeriodizationLinear Periodization Running (Crossover Design) |
| Non Linear Periodization | Active comparator | Behavioral: Linear PeriodizationNon Linear Periodization Running (Crossover Design) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Minimum standards of physical activity proposed by the ACSM
- 18-45 years
- No metabolic or cardiovascular events
- No use ergogenic resources
Key exclusion criteria (3 listed)
- Sedentary
- Diagnosis of cardiac, pulmonary or diabetes type I or II
- No injuries
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 |
|---|---|---|
| Linear PeriodizationAlso: LP, Progressive PeriodizationLinear Intensity Periodization Running | Behavioural | Non Linear Periodization |
| Non Linear PeriodizationAlso: NLP, Randomized IntensityNon Linear Periodization Running | Behavioural | Linear Periodization |
Primary outcome
VO2Max
Time frame: 0 - 2 month; 1 month (wash out); 3 - 5 month
Observe the improvement of VO2max
2 secondary outcomes
Critical Power
Time frame: 0 - 2 month; 1 month (wash out); 3 - 5 month
Peak Velocity
Time frame: 0 - 2 month; 1 month (wash out); 3 - 5 month
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 20 Jan 2016.
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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.
Sérgio Machado, PhD study director
Universidade Federal do Rio de Janeiro
Questions about this trial
What is this clinical trial studying?
A study testing Linear Periodization and Non Linear Periodization in people with Healthy, run by Universidade Federal do Rio de Janeiro.
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 4 inclusion and 3 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 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
VO2Max (time frame: 0 - 2 month; 1 month (wash out); 3 - 5 month). 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 20 Jan 2016.