NCT04241991

Brief Summary

The present project aims to investigate the acute and chronic effects of laser photobiomodulation (PBM) at 808 nm on muscle performance in physically active elderly women. The hypothesis of this study is that laser PBM would improve muscle strength (i.e., MVIC and 1RM) and endurance (i.e., repetitions-to-failure, blood lactate levels), functional capacity (i.e., short physical performance battery score), and rating of perceived exertion when compared with placebo laser.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

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

November 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

January 21, 2020

Last Update Submit

January 24, 2020

Conditions

Keywords

PhotobiomodulationMuscle functionElderlyResistance exerciseBalance

Outcome Measures

Primary Outcomes (6)

  • Change in vastus lateralis thickness

    Muscle thickness measured by ultrasonography

    Baseline and after 10 weeks

  • Change in maximal dynamic strength by 1RM

    1RM for knee extension exercise.

    Baseline and after 10 weeks

  • Change in MVIC

    MVIC using a portable fixed dynamometry (i.e., compression load cell)

    Immediately after intervention (Trial 1), and baseline and after 10 weeks (Trial 2)

  • Change in functional capacity

    Functional capacity measured by short physical performance battery (SPPB)

    Immediately after intervention (Trial 1).

  • Change in balance

    Balance performance using a force platform.

    Baseline and after 10 weeks (Trial 2)

  • Change in repetitions-to-failure

    Repetitions-to-failure test on a knee extension machine.

    Immediately after intervention (Trial 1), and baseline and after 10 weeks (Trial 2)

Secondary Outcomes (2)

  • Change in lactate levels

    Immediately after repetitions-to-failure test (trial 1)

  • Change in perceived exertion

    Immediately after repetitions-to-failure test (trial 1)

Study Arms (2)

Active laser

EXPERIMENTAL

Each participant will receive the application of the active laser on the rectus femoris muscle during the trials 1 (acute) and 2 (chronic).

Radiation: Active laser

Placebo laser

PLACEBO COMPARATOR

Each participant will receive the application of the placebo laser on the rectus femoris muscle during the trials 1 (acute) and 2 (chronic).

Radiation: Placebo laser

Interventions

Active laserRADIATION

Participants will receive laser irradiation on the rectus femoris muscle of both legs immediately before the test (trial 1) and training (trial 2) sessions. A researcher blinded to the treatment conditions will apply the irradiation on eight points distributed over the muscle belly, using a gallium arsenide aluminum (Ga-As-Al) laser (λ: 808 nm) equipment. The points will placed at 25, 35, 50 and 75% of the total distance between the anterior superior iliac spine and superior border of the patella, bilaterally, with 2 cm of distance between each point.

Also known as: Active laser therapy
Active laser
Placebo laserRADIATION

Participants will receive placebo irradiation on the rectus femoris muscle of both legs immediately before the test (trial 1) and training (trial 2) sessions. A researcher blinded to the treatment conditions will apply the placebo irradiation on eight points distributed over the muscle belly. The points will placed at 25, 35, 50 and 75% of the total distance between the anterior superior iliac spine and superior border of the patella, bilaterally, with 2 cm of distance between each point.

Also known as: Placebo laser therapy
Placebo laser

Eligibility Criteria

Age65 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 65-80 y,
  • Classified as eutrophic (i.e., body mass index ≤ 27 kg/m2), and
  • Classified as physically active (i.e., performing at least 150 min/week of moderate physical activity) according to criteria of the International Physical Activity Questionnaire (IPAQ) for elderly

You may not qualify if:

  • To be tobacco product users
  • To make use of any ergogenic supplement within six months prior to the start of the study;
  • To make use of any medication that could affect the ability to perform the physical tests;
  • To have any physiological (e.g., cardiorespiratory and metabolic diseases, uncontrolled hypertension, or diabetes) or physical limitation (e.g., orthopedic or rheumatic diseases, muscular injury, fibromyalgia, or pain) that could affect the ability to perform the physical tests, or
  • To be unable to understand the informed consent document and provide a detailed description of their lifestyle.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Norte do Paraná

Londrina, Paraná, 86.041-140, Brazil

Location

Study Officials

  • Andreo Aguiar, Dr.

    North University of Paraná

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants and researchers used dark laser goggles for eye protection against irradiation, and participants were blinded by a blindfold on top of safety glasses.
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 27, 2020

Study Start

November 1, 2019

Primary Completion

January 15, 2020

Study Completion

January 15, 2020

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations