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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05595564
Other study ID # Hypoxia_PBM
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 31, 2021
Est. completion date December 31, 2022

Study information

Verified date October 2022
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 7
Est. completion date December 31, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 29 Years
Eligibility 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 Design


Intervention

Device:
Photobiomodulation therapy
A previous application of photobiomodulation therapy was offered or not, for possible performance enhancement.

Locations

Country Name City State
Brazil University of Sao Paulo Ribeirao Preto Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Analysis of excess oxygen consumption observed after exercise and blood lactate To investigate the effects of photobiomodulation on anaerobic capacity in normoxia and hypoxia conditions in amateur runners 1 year
Secondary Analysis of V02 max by a single supramaximal effort performed to exhaustion 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
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