- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02493556
Effect of Low-level Laser Therapy on Exercise-induced Muscle Damage
Effect of Low-level Laser Therapy on Exercise-induced Muscle Damage: a Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil, 90050-170
- Federal University of Health Science of Porto Alegre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy males aged between 18 and 35 years;
- Sedentary or physically active individuals who exercise up to 3 times per week.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LLLT before muscle damage
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.
|
|
|
Placebo Comparator: Placebo LLLT before muscle damage
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.
|
|
|
Active Comparator: LLLT after muscle damage
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.
|
|
|
Placebo Comparator: Placebo LLLT after muscle damage
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee extensors isometric peak torque (Nm)
Time Frame: Baseline and 24, 48 and 72 hours follow-up
|
Isokinetic Dynamometer
|
Baseline and 24, 48 and 72 hours follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Knee extensors soreness (Visual Analogue scale)
Time Frame: Baseline and 24, 48 and 72 hours follow-up
|
Baseline and 24, 48 and 72 hours follow-up
|
|
Knee extensors echo intensity (number of white and black pixels)
Time Frame: Baseline and 24, 48 and 72 hours follow-up
|
Baseline and 24, 48 and 72 hours follow-up
|
Collaborators and Investigators
Investigators
- Study Director: Bruno Baroni, phD, Federal University of Health Science of Porto Alegre
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 38076514.0.0000.5345
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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