Photobiomodulation (PBM) Therapy on Muscle Performance in Elderly Women

Effects of Laser Photobiomodulation (PBM) Therapy at 808 nm on Muscle Performance in Elderly Women: a Randomized, Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Performance; Aged; Muscle Strength; Resistance Training; Lasers
• Intervention / Treatment: Radiation: Active laser; Radiation: Placebo laser

Detailed Description

The purpose of this study will be to investigate the acute and chronic effects of laser PBM (λ: 808 nm) on muscle performance in physically active elderly women. For this purpose, the participants will be enrolled in two trials: Trial 1: Initially, all participants (n = 20/group) will be submitted for a 1-wk familiarization period (3 non-consecutive sessions) of functional tests (i.e., standing balance, gait speed, and chair stand tests) from short physical performance battery (SPPB), knee flexion-extension exercise (3 sets of 10-12 repetitions), maximum voluntary isometric contraction (MVIC), balance test on a force platform, and one-repetition maximum (1RM) test for knee extension exercise. Thereafter, participants will be randomized to receive 1 of 2 treatments (active or placebo laser) on two occasions (T1 and T2), separated by a 7-day washout period. During T1 and T2, participants will receive their respective treatments and then perform the muscle performance tests, separated by 10 minutes, in the following order: SPPB, MVIC, and repetitions-to-failure. After the last test, the participants will be instructed to reported the perceived exertion by OMNI scale, and a blood sample will be collected for measurement of blood lactate levels. Differences between groups will be assessed using a 2-tailed paired t-test. The significance level will be 0.05. Trial 2: participants will be randomized into two groups (n = 20/group): active laser or placebo laser. Both groups will be submitted for a 10-wk resistance training program (2 x/week) involving unilateral knee extension exercise. The following variables will be assessed from pre-to post-training: anthropometric, muscle thickness from vastus lateralis muscle using ultrasound, MVIC, 1RM, repetition-to-failure, and balance variables on a force platform. Shapiro-Wilk and Levine tests will be used to test the normality and homogeneity of the measurements, respectively. Two-way ANOVA (group x time) tests for repeated measures will be performed to assess changes over time and between groups for all dependent variables. Violation of sphericity will adjust using Greenhouse-Geser correction. The Bonferroni post-hoc test will detect specific differences between groups. When appropriate, the percentage of change (∆%) will be reported according to the following equation: ∆% = [(pre-average post average) / pre-average mean] × 100. Values will be express as mean ± standard deviation. O significance level α will be 0.05.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Paraná
    • Londrina, Paraná, Brazil, 86.041-140
      • Universidade Norte do Paraná

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active laser; 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; 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.; Other Names: Active laser therapy
Placebo Comparator: Placebo laser; 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; 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.; Other Names: Placebo laser therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lactate levels	Blood samples will be collected for analyse of the lactate levels after repetitions-to-failure test	Immediately after repetitions-to-failure test (trial 1)
Change in perceived exertion	Perceived exertion after repetitions-to-failure test using the OMNI scale	Immediately after repetitions-to-failure test (trial 1)

Collaborators and Investigators

• Sponsor: Universidade Norte do Paraná
• Collaborators: Universidade Estadual de Londrina
• Investigators: Principal Investigator: Andreo Aguiar, Dr., North University of Paraná

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): January 15, 2020
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Elderly; Balance; Photobiomodulation; Resistance exercise; Muscle function
• Other Study ID Numbers: 2.893.464

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No