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Completed

NCT Number: NCT04241991

Photobiomodulation (PBM) Therapy on Muscle Performance in Elderly Women

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.

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Key information

Age range

65 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Norte do Paraná

Londrina, Paraná, 86.041-140, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active laser

Radiation

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 laser

Radiation

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

Primary outcomes

  1. Change in vastus lateralis thickness

    Time frame: Baseline and after 10 weeks

    Muscle thickness measured by ultrasonography

  2. Change in maximal dynamic strength by 1RM

    Time frame: Baseline and after 10 weeks

    1RM for knee extension exercise.

  3. Change in MVIC

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

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

  4. Change in functional capacity

    Time frame: Immediately after intervention (Trial 1).

    Functional capacity measured by short physical performance battery (SPPB)

  5. Change in balance

    Time frame: Baseline and after 10 weeks (Trial 2)

    Balance performance using a force platform.

  6. Change in repetitions-to-failure

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

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

Secondary outcomes

  1. Change in lactate levels

    Time frame: Immediately after repetitions-to-failure test (trial 1)

    Blood samples will be collected for analyse of the lactate levels after repetitions-to-failure test

  2. Change in perceived exertion

    Time frame: Immediately after repetitions-to-failure test (trial 1)

    Perceived exertion after repetitions-to-failure test using the OMNI scale

Sponsors and collaborators

Lead sponsor

Universidade Norte do Paraná

Other

Collaborators

  • Universidade Estadual de Londrina

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 27, 2020
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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