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Influence of PBM on Anaerobic Capacity Under Normoxia and Hypoxia

Primary Purpose

Low Level Laser Therapy, Photobiomodulation, Performance

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Photobiomodulation therapy
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Low Level Laser Therapy focused on measuring Physical Therapy, Photobiomodulation, Athletic Performance, Hypoxia

Eligibility Criteria

18 Years - 29 Years (Adult)MaleAccepts Healthy Volunteers

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;

Sites / Locations

  • University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypoxia

Normoxia

Arm Description

Participant developed running activity on a treadmill in hypoxic condition, submitted or not to photobiomodulation therapy.

Participant developed treadmill running activity in normoxic condition, submitted or not to photobiomodulation therapy.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 18, 2022
Last Updated
October 21, 2022
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT05595564
Brief Title
Influence of PBM on Anaerobic Capacity Under Normoxia and Hypoxia
Official Title
Influence of Photobiomodulation on Anaerobic Capacity Under Normoxia and Hypoxia Conditions in Treadmill Runners
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Level Laser Therapy, Photobiomodulation, Performance, Sport
Keywords
Physical Therapy, Photobiomodulation, Athletic Performance, Hypoxia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypoxia
Arm Type
Experimental
Arm Description
Participant developed running activity on a treadmill in hypoxic condition, submitted or not to photobiomodulation therapy.
Arm Title
Normoxia
Arm Type
Active Comparator
Arm Description
Participant developed treadmill running activity in normoxic condition, submitted or not to photobiomodulation therapy.
Intervention Type
Device
Intervention Name(s)
Photobiomodulation therapy
Intervention Description
A previous application of photobiomodulation therapy was offered or not, for possible performance enhancement.
Primary Outcome Measure Information:
Title
Analysis of excess oxygen consumption observed after exercise and blood lactate
Description
To investigate the effects of photobiomodulation on anaerobic capacity in normoxia and hypoxia conditions in amateur runners
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Analysis of V02 max by a single supramaximal effort performed to exhaustion
Description
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
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos E Girasol, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo
City
Ribeirao Preto
State/Province
Sao Paulo
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data will be shared in the form of the manuscript.
Citations:
PubMed Identifier
25585514
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.
Results Reference
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PubMed Identifier
31605635
Citation
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.
Results Reference
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Influence of PBM on Anaerobic Capacity Under Normoxia and Hypoxia

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