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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02493556
Other study ID # 38076514.0.0000.5345
Secondary ID
Status Completed
Phase N/A
First received July 7, 2015
Last updated October 13, 2015
Start date June 2015
Est. completion date September 2015

Study information

Verified date July 2015
Source Federal University of Health Science of Porto Alegre
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date September 2015
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
LLLT before muscle damage

Placebo LLLT before muscle damage

LLLT after muscle damage

Placebo LLLT after muscle damage


Locations

Country Name City State
Brazil Federal University of Health Science of Porto Alegre Porto Alegre RS

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Knee extensors isometric peak torque (Nm) Isokinetic Dynamometer Baseline and 24, 48 and 72 hours follow-up Yes
Secondary Knee extensors soreness (Visual Analogue scale) Baseline and 24, 48 and 72 hours follow-up Yes
Secondary Knee extensors echo intensity (number of white and black pixels) Baseline and 24, 48 and 72 hours follow-up Yes
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