NCT05595564

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

10 months

First QC Date

October 18, 2022

Last Update Submit

October 21, 2022

Conditions

Keywords

Physical TherapyPhotobiomodulationAthletic PerformanceHypoxia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Analysis of V02 max by a single supramaximal effort performed to exhaustion

    1 year

Study Arms (2)

Hypoxia

EXPERIMENTAL

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

Device: Photobiomodulation therapy

Normoxia

ACTIVE COMPARATOR

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

Device: Photobiomodulation therapy

Interventions

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

HypoxiaNormoxia

Eligibility Criteria

Age18 Years - 29 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy individuals
  • VO2 maximal equal to or greater than 34 ml/kg.min
  • capacity for physical activity according to the PAR-Q questionnaire

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 25585514BACKGROUND
  • 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.

    PMID: 31605635BACKGROUND

MeSH Terms

Conditions

Hypoxia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Carlos E Girasol, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 18, 2022

First Posted

October 27, 2022

Study Start

August 31, 2021

Primary Completion

July 1, 2022

Study Completion

December 31, 2022

Last Updated

October 27, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

The data will be shared in the form of the manuscript.

Locations