NCT05344183

Brief Summary

Athletes experience an exhaustive routine of training, associated with the reduced time of rest, facilitates the appearance of muscle fatigue, which increases the risk of muscle injuries, especially during the execution of the jump. Low Level Lasertherapy is a technique that has been increasingly improved due to the physiological effects it provides in the muscle recovery process. However, there is still a lack of studies focused on the use of this technique in functional improvement, especially in jumping sports. Objectives: To evaluate the immediate and short-term effects of low-level laser on the functional performance of lower limbs of jumping athletes and to evaluate the short-term effects of low-level laser on the activation of the gluteus medius and quadriceps muscles. Methods: This is a brief, double-blind, randomized, placebo-controlled clinical trial. Will be recruited 24 handball and volleyball players aged between 18 to 35 years. The primary outcome of our study is functional performance (modified hop test and modified SEBT), and as a secondary outcome (level of electromyographic activity). After the baseline assessments, the athletes will be randomized and allocated into two groups: Intervention Group (IG, n=12) and Control Group (CG, n=12) and submitted to a fatigue protocol, followed by laser therapy or placebo.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 3, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

April 12, 2022

Last Update Submit

May 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Functional Performance

    For the evaluation of the functional performance, the tests will be used is the horizontal unipedal jump.

    6 days

Secondary Outcomes (1)

  • Muscle activity

    2 days

Study Arms (2)

Lasertherapy

EXPERIMENTAL
Device: Low-level laser

Sham lasertherapy

SHAM COMPARATOR
Device: Low-level laser

Interventions

A laser will be used in the quadriceps and gluteus medius muscles with the following parameters described for muscle recovery: dose of 40 J for the gluteus medius muscle, 180 J for the quadriceps muscle; power from 50 to 200 mW per diode (for single probes), 10 to 35 mW per diode (for cluster probes). The full power of the device cannot lead to thermal effects; Wavelengths of 950 nm (infrared).

LasertherapySham lasertherapy

Eligibility Criteria

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

You may qualify if:

  • Handball and volleyball athletes;
  • Age between 18 and 35 years;
  • Both sexes;
  • Athletes who maintain a training routine for their sport, at least twice a week

You may not qualify if:

  • History of acute injury to the lower limbs (LL) in the last 2 months;
  • Occurrence of pain and injury during the study;
  • Any change in physical activity routine during the week of assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renan Lima Monteiro

Macapá, Amapá, 68903-419, Brazil

Location

MeSH Terms

Conditions

Fatigue

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

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

Study Record Dates

First Submitted

April 12, 2022

First Posted

April 25, 2022

Study Start

September 3, 2022

Primary Completion

November 12, 2023

Study Completion

December 12, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations