- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05595564
Influence of PBM on Anaerobic Capacity Under Normoxia and Hypoxia
October 21, 2022 updated by: Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
Influence of Photobiomodulation on Anaerobic Capacity Under Normoxia and Hypoxia Conditions in Treadmill Runners
The photobiomodulation (PBM) shows positive results in muscle performance, fatigue reduction, management of blood lactate production, analgesia and in the increase of VO2 maximal, favoring the increase of ATP production and thus the energy metabolism.
The association of PBM applied before high-intensity treadmill training shows physiological improvements both in normoxic (Nor) and hypoxic (Hip) conditions.
Anaerobic capacity (AC) is the maximum amount of ATP that can be resynthesized by anaerobic metabolism and is an important predictor of high-intensity exercise since an athlete's ability to perform efforts to increase maximal oxygen consumption (VO2max) depends on AL.
In view of the above information the main objective of the present research project will be to investigate the effects of PBM on AC under normoxic and hypoxic conditions in amateur runners.
To test the effects of exercise training on anaerobic capacity under normoxic and hypoxic conditions, 7 individuals will be randomly submitted to four maximal efforts to exhaustion with intensity corresponding to 110% of VO2max in Hip, Nor, Hip+Ebio and Nor+Ebio conditions.
These efforts will be used to estimate the AC, that is, the maximum accumulated deficit of alternative oxygen (MAODRED), from the sum of the energy contribution of the anaerobic and lactic metabolisms.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sao Paulo
-
Ribeirao Preto, Sao Paulo, Brazil, 14049-900
- University of Sao Paulo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- healthy individuals
- VO2 maximal equal to or greater than 34 ml/kg.min
- capacity for physical activity according to the PAR-Q questionnaire
Exclusion Criteria:
- musculoskeletal injury in the last three months;
- cardiovascular diseases;
- use of anabolic, anti-inflammatory and analgesic drugs 72 hours before the evaluations;
- use of alcohol and illicit drugs during the collection period;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hypoxia
Participant developed running activity on a treadmill in hypoxic condition, submitted or not to photobiomodulation therapy.
|
A previous application of photobiomodulation therapy was offered or not, for possible performance enhancement.
|
|
Active Comparator: Normoxia
Participant developed treadmill running activity in normoxic condition, submitted or not to photobiomodulation therapy.
|
A previous application of photobiomodulation therapy was offered or not, for possible performance enhancement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analysis of excess oxygen consumption observed after exercise and blood lactate
Time Frame: 1 year
|
To investigate the effects of photobiomodulation on anaerobic capacity in normoxia and hypoxia conditions in amateur runners
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analysis of V02 max by a single supramaximal effort performed to exhaustion
Time Frame: 1 year
|
To determine the alactic and lactic anaerobic and lactic anaerobic participation during exhaustive effort performed at 120% of VO2max in normoxia, hypoxia and with intervention of photobiomodulation
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carlos E Girasol, PhD, University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ferraresi C, Beltrame T, Fabrizzi F, do Nascimento ES, Karsten M, Francisco Cde O, Borghi-Silva A, Catai AM, Cardoso DR, Ferreira AG, Hamblin MR, Bagnato VS, Parizotto NA. Muscular pre-conditioning using light-emitting diode therapy (LEDT) for high-intensity exercise: a randomized double-blind placebo-controlled trial with a single elite runner. Physiother Theory Pract. 2015 Jul;31(5):354-61. doi: 10.3109/09593985.2014.1003118. Epub 2015 Jan 14.
- Ando S, Komiyama T, Sudo M, Higaki Y, Ishida K, Costello JT, Katayama K. The interactive effects of acute exercise and hypoxia on cognitive performance: A narrative review. Scand J Med Sci Sports. 2020 Mar;30(3):384-398. doi: 10.1111/sms.13573. Epub 2019 Oct 27.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 31, 2021
Primary Completion (Actual)
July 1, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
October 18, 2022
First Submitted That Met QC Criteria
October 21, 2022
First Posted (Actual)
October 27, 2022
Study Record Updates
Last Update Posted (Actual)
October 27, 2022
Last Update Submitted That Met QC Criteria
October 21, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hypoxia_PBM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
The data will be shared in the form of the manuscript.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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