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临床试验/NCT04241991
NCT04241991已完成不适用

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

Universidade Norte do Paraná2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Change in balance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Double (Participant, Investigator)

盲法说明

Participants and researchers used dark laser goggles for eye protection against irradiation, and participants were blinded by a blindfold on top of safety glasses.

入排标准

年龄范围
65 Years 至 80 Years(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Change in balance

时间窗: Baseline and after 10 weeks (Trial 2)

Balance performance using a force platform.

Change in repetitions-to-failure

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

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

Change in MVIC

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

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

Change in functional capacity

时间窗: Immediately after intervention (Trial 1).

Functional capacity measured by short physical performance battery (SPPB)

Change in vastus lateralis thickness

时间窗: Baseline and after 10 weeks

Muscle thickness measured by ultrasonography

Change in maximal dynamic strength by 1RM

时间窗: Baseline and after 10 weeks

1RM for knee extension exercise.

次要结局

  • Change in perceived exertion(Immediately after repetitions-to-failure test (trial 1))
  • Change in lactate levels(Immediately after repetitions-to-failure test (trial 1))

研究者

发起方
Universidade Norte do Paraná
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreo Fernando Aguiar

Principal Investigator

Universidade Norte do Paraná

研究点 (2)

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