NCT02493556

Brief Summary

Introduction: The effects of Low Level Laser Therapy (LLLT) on exercise-induced muscular damage have been studied over the last years. Studies have been conducted on animals and humans in order to try to show the benefits of the intervention, but there is still conflicting evidence about its protective and therapeutic effects. Objectives: To describe the effects of LLLT on pain, strength and muscular inflammation after plyometric exercise. Methods: A randomized, double-blinded, placebo-controlled trial with participation of 20 male healthy volunteers will be performed. Healthy and physically active individuals, aged between 18 and 35 years, with no history of injury on the lower limbs or contra-indications to maximal exercise performance will be included. A protocol of 10 series with 10 repetitions of the countermovement jump will be used to induce muscle damage at the lower limbs. Immediately before or after the exercise protocol, LLLT will be applied on one lower limb, while the other will receive placebo treatment. Phototherapy will be applied with an equipment of 810nm and a cluster with 5 diodes on 8 different points of the knee extensor muscle, totalizing a dosage of 240J. The placebo treatment will be held on the same way, but the equipment will be turned off. The volunteers will be evaluated at baseline (before the exercise protocol) and at follow-up of 24, 48 and 72 hours. The following outcomes will be evaluated: knee extensors isometric peak torque by Isokinetic Dynamometer, pain by Visual Analogue Scale and muscular tissue echo intensity by Ultrasonography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 15, 2015

Status Verified

July 1, 2015

Enrollment Period

2 months

First QC Date

July 7, 2015

Last Update Submit

October 13, 2015

Conditions

Keywords

PhototherapyPlyometric exerciseMuscle recovery

Outcome Measures

Primary Outcomes (1)

  • Knee extensors isometric peak torque (Nm)

    Isokinetic Dynamometer

    Baseline and 24, 48 and 72 hours follow-up

Secondary Outcomes (2)

  • Knee extensors soreness (Visual Analogue scale)

    Baseline and 24, 48 and 72 hours follow-up

  • Knee extensors echo intensity (number of white and black pixels)

    Baseline and 24, 48 and 72 hours follow-up

Study Arms (4)

LLLT before muscle damage

EXPERIMENTAL

Low Level Laser Therapy (LLLT) will be applied before the exercise protocol on one lower limb, while the other will receive placebo treatment. Phototherapy will be applied with an equipment of 810nm and a cluster with five diodes on eight different points of quadriceps muscle, totalizing a dosage of 240J.

Device: LLLT before muscle damage

Placebo LLLT before muscle damage

PLACEBO COMPARATOR

Placebo LLLT will be applied before the exercise protocol on one lower limb, while the other will receive real treatment. Placebo treatment will also be applied on eight different points of quadriceps muscle, but the equipment will be turned off.

Device: Placebo LLLT before muscle damage

LLLT after muscle damage

ACTIVE COMPARATOR

Low Level Laser Therapy (LLLT) will be applied after the exercise protocol on one lower limb, while the other will receive placebo treatment. Phototherapy will be applied with an equipment of 810nm and a cluster with five diodes on eight different points of quadriceps muscle, totalizing a dosage of 240J.

Device: LLLT after muscle damage

Placebo LLLT after muscle damage

PLACEBO COMPARATOR

Placebo LLLT will be applied after the exercise protocol on one lower limb, while the other will receive real treatment. Placebo treatment will also be applied on eight different points of quadriceps muscle, but the equipment will be turned off.

Device: Placebo LLLT after muscle damage

Interventions

LLLT before muscle damage
Placebo LLLT before muscle damage
LLLT after muscle damage
Placebo LLLT after muscle damage

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males aged between 18 and 35 years;
  • Sedentary or physically active individuals who exercise up to 3 times per week.

You may not qualify if:

  • Individuals who participate in systematic exercise training;
  • Individuals who participate in strength training for the lower limbs;
  • Individuals with lower or upper limb injuries;
  • Individuals with contra-indications to maximal exercise performance (due to neurological, cardiovascular or respiratory conditions);
  • Individuals who show difficulties to understand the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Health Science of Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

Study Officials

  • Bruno Baroni, phD

    Federal University of Health Science of Porto Alegre

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 7, 2015

First Posted

July 9, 2015

Study Start

June 1, 2015

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

October 15, 2015

Record last verified: 2015-07

Locations