Local and Systemic Effects of Photobiomodulation Therapy on Muscle Performance and Recovery Post-exercise.

NCT03695458 | Completed DMC

• 1 other identifier: 617150400
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Recent studies with photobiomodulation therapy have shown positive results in delaying skeletal muscle fatigue and improving performance through levels of biochemical markers and variables related to exercise when this therapy was applied before exercise. Some studies suggest that photobiomodulation therapy has systemic effects, but it is not known whether therapy exerts any systemic effects on human skeletal muscle. With this factor in mind, this research aims to verify the local and systemic effects of phototherapy on muscle performance and recovery after exercise in healthy male participants. This research consists in a randomized, triple-blinded, placebo-controlled trial, with participation of 30 healthy subjects. Will be analyzed parameters related to exercise performance (peak torque in the maximum voluntary contraction test- MVC), delayed onset muscle soreness (DOMS) by visual analogue scale (VAS), and biochemical marker of muscle damage (CK) and blood Lactate (BL). The analysis will be performed before exercise protocol (baseline), after 1 minute of the exercise, and 1, 24, 48 and 72 hours after the end of exercise protocol

Conditions

Phototherapy; Low-level Laser Therapy; Systemic

Keywords

phototherapy; systemic effect; recovery; performance; photobiomodulation

Outcome Measures

Primary Outcomes (6)

• Maximum Voluntary Contraction

  An isokinetic dynamometer (System 4, Biodex®, USA) will be used to assess muscle function and also for exercise protocol. Immediately after warm-up, volunteers will perform the maximum voluntary contraction test (MVC). Volunteers will be placed on the isokinetic dynamometer seated with a 100° angle between trunk and hip, and the non-dominant leg will be positioned to 60° knee flexion (0° corresponds to the total knee extension) and attached to the seat of the dynamometer through a belt. Volunteers will also be attached to the dynamometer seat through two straps on their trunk. MVC test consists of three isometric contractions of non-dominant lower limb knee extensors with a duration of 5 seconds and 30-second intervals between contractions, the highest torque value obtained at the three contractions (peak torque) will be used for statistical analysis.

  baseline

• Maximum Voluntary Contraction

  An isokinetic dynamometer (System 4, Biodex®, USA) will be used to assess muscle function and also for exercise protocol. Immediately after warm-up, volunteers will perform the maximum voluntary contraction test (MVC). Volunteers will be placed on the isokinetic dynamometer seated with a 100° angle between trunk and hip, and the non-dominant leg will be positioned to 60° knee flexion (0° corresponds to the total knee extension) and attached to the seat of the dynamometer through a belt. Volunteers will also be attached to the dynamometer seat through two straps on their trunk. MVC test consists of three isometric contractions of non-dominant lower limb knee extensors with a duration of 5 seconds and 30-second intervals between contractions, the highest torque value obtained at the three contractions (peak torque) will be used for statistical analysis.

  1 minute after the protocol of eccentric contractions

• Maximum Voluntary Contraction

  An isokinetic dynamometer (System 4, Biodex®, USA) will be used to assess muscle function and also for exercise protocol. Immediately after warm-up, volunteers will perform the maximum voluntary contraction test (MVC). Volunteers will be placed on the isokinetic dynamometer seated with a 100° angle between trunk and hip, and the non-dominant leg will be positioned to 60° knee flexion (0° corresponds to the total knee extension) and attached to the seat of the dynamometer through a belt. Volunteers will also be attached to the dynamometer seat through two straps on their trunk. MVC test consists of three isometric contractions of non-dominant lower limb knee extensors with a duration of 5 seconds and 30-second intervals between contractions, the highest torque value obtained at the three contractions (peak torque) will be used for statistical analysis.

  1 hour after the protocol of eccentric contractions

• Maximum Voluntary Contraction

  An isokinetic dynamometer (System 4, Biodex®, USA) will be used to assess muscle function and also for exercise protocol. Immediately after warm-up, volunteers will perform the maximum voluntary contraction test (MVC). Volunteers will be placed on the isokinetic dynamometer seated with a 100° angle between trunk and hip, and the non-dominant leg will be positioned to 60° knee flexion (0° corresponds to the total knee extension) and attached to the seat of the dynamometer through a belt. Volunteers will also be attached to the dynamometer seat through two straps on their trunk. MVC test consists of three isometric contractions of non-dominant lower limb knee extensors with a duration of 5 seconds and 30-second intervals between contractions, the highest torque value obtained at the three contractions (peak torque) will be used for statistical analysis.

  24 hours after the protocol of eccentric contractions

• Maximum Voluntary Contraction

  An isokinetic dynamometer (System 4, Biodex®, USA) will be used to assess muscle function and also for exercise protocol. Immediately after warm-up, volunteers will perform the maximum voluntary contraction test (MVC). Volunteers will be placed on the isokinetic dynamometer seated with a 100° angle between trunk and hip, and the non-dominant leg will be positioned to 60° knee flexion (0° corresponds to the total knee extension) and attached to the seat of the dynamometer through a belt. Volunteers will also be attached to the dynamometer seat through two straps on their trunk. MVC test consists of three isometric contractions of non-dominant lower limb knee extensors with a duration of 5 seconds and 30-second intervals between contractions, the highest torque value obtained at the three contractions (peak torque) will be used for statistical analysis.

  48 hours after the protocol of eccentric contractions

• Maximum Voluntary Contraction

  An isokinetic dynamometer (System 4, Biodex®, USA) will be used to assess muscle function and also for exercise protocol. Immediately after warm-up, volunteers will perform the maximum voluntary contraction test (MVC). Volunteers will be placed on the isokinetic dynamometer seated with a 100° angle between trunk and hip, and the non-dominant leg will be positioned to 60° knee flexion (0° corresponds to the total knee extension) and attached to the seat of the dynamometer through a belt. Volunteers will also be attached to the dynamometer seat through two straps on their trunk. MVC test consists of three isometric contractions of non-dominant lower limb knee extensors with a duration of 5 seconds and 30-second intervals between contractions, the highest torque value obtained at the three contractions (peak torque) will be used for statistical analysis.

  72 hours after the protocol of eccentric contractions

Secondary Outcomes (18)

• enzymatic activity of creatine kinase (CK)

  baseline

• enzymatic activity of creatine kinase (CK)

  1 minute after the protocol of eccentric contractions

• enzymatic activity of creatine kinase (CK)

  1 hour after the protocol of eccentric contractions

• enzymatic activity of creatine kinase (CK)

  24 hours after the protocol of eccentric contractions

• enzymatic activity of creatine kinase (CK)

  48 hours after the protocol of eccentric contractions

Study Arms (3)

Placebo-Control

PLACEBO COMPARATOR

Photobiomodulation Therapy with the placebo program will be applied in both legs.

Device: Phototherapy

irradiation effect Local

ACTIVE COMPARATOR

Photobiomodulation Therapy with the active irradiation will be applied on the exercised leg and Photobiomodulation Therapy with the placebo program will be applied on the non-exercised leg.

Device: Phototherapy

irradiation effect Systemic

ACTIVE COMPARATOR

Photobiomodulation Therapy with the active program will be applied on non-exercised leg and Photobiomodulation Therapy with the placebo program will be applied on the exercised leg.

Device: Phototherapy

Interventions

Phototherapy DEVICE

The Photobiomodulation Therapy will be applied 3 minutes after MVC test in 6 points of the quadriceps muscle (2 points in vastus lateralis, 2 in rectus femoris and 2 in vastus medialis).

Also known as: Photobiomodulation Therapy, Low-Level Laser Therapy

Placebo-Control; irradiation effect Local; irradiation effect Systemic

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals,
• Non-athletes
• Those who practice physical activity at maximal of once a week
• Between 18 and 35 years old,
• Male
• No history of musculoskeletal injury in the hip or knee previous two months of the study.
• Not be taking pharmacological agents and / or nutritional supplements, and should have frequency of 100% in all days of data collection.

You may not qualify if:

• Individuals who present musculoskeletal injury during the study
• Chronic joint disease in the non-dominant lower limb

Sponsors & Collaborators

• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• University of Nove de Julho: lead

Study Sites (1)

Universidade Nove de Julho

São Paulo, São Paulo, 01504-001, Brazil

Location

Related Publications (4)

• Vanin AA, Miranda EF, Machado CS, de Paiva PR, Albuquerque-Pontes GM, Casalechi HL, de Tarso Camillo de Carvalho P, Leal-Junior EC. What is the best moment to apply phototherapy when associated to a strength training program? A randomized, double-blinded, placebo-controlled trial : Phototherapy in association to strength training. Lasers Med Sci. 2016 Nov;31(8):1555-1564. doi: 10.1007/s10103-016-2015-7. Epub 2016 Jul 1.

  PMID: 27371449 BACKGROUND

• Miranda EF, Vanin AA, Tomazoni SS, Grandinetti Vdos S, de Paiva PR, Machado Cdos S, Monteiro KK, Casalechi HL, de Tarso P, de Carvalho C, Leal-Junior EC. Using Pre-Exercise Photobiomodulation Therapy Combining Super-Pulsed Lasers and Light-Emitting Diodes to Improve Performance in Progressive Cardiopulmonary Exercise Tests. J Athl Train. 2016 Feb;51(2):129-35. doi: 10.4085/1062-6050-51.3.10. Epub 2016 Mar 4.

  PMID: 26942660 BACKGROUND

• Antonialli FC, De Marchi T, Tomazoni SS, Vanin AA, dos Santos Grandinetti V, de Paiva PR, Pinto HD, Miranda EF, de Tarso Camillo de Carvalho P, Leal-Junior EC. Phototherapy in skeletal muscle performance and recovery after exercise: effect of combination of super-pulsed laser and light-emitting diodes. Lasers Med Sci. 2014 Nov;29(6):1967-76. doi: 10.1007/s10103-014-1611-7. Epub 2014 Jun 19.

  PMID: 24942380 BACKGROUND

• Machado CDSM, Casalechi HL, Vanin AA, de Azevedo JB, de Carvalho PTC, Leal-Junior ECP. Does photobiomodulation therapy combined to static magnetic field (PBMT-sMF) promote ergogenic effects even when the exercised muscle group is not irradiated? A randomized, triple-blind, placebo-controlled trial. BMC Sports Sci Med Rehabil. 2020 Aug 26;12:49. doi: 10.1186/s13102-020-00197-6. eCollection 2020.

  PMID: 32864144 DERIVED

MeSH Terms

Interventions

Phototherapy; Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Laser Therapy

Study Officials

• Caroline M Machado, 1

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Phototherapy pad with six clusters of 12 diodes each one will be placed in both legs. Only one researcher, that will be not involved with any procedure during data collection and analysis, will know about the phototherapy program used in which leg and randomization procedure. The light aspect is the same independent of the program (active or placebo) applied and all participants will wear a opaque glasses to protect against irradiation and also assure the blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Model Details: Randomized, triple-blind and placebo-controlled

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: October 4, 2018
• Study Start: January 14, 2019
• Primary Completion: April 14, 2019
• Study Completion: May 14, 2019
• Last Updated: December 2, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)