跳至主要内容
临床试验/NCT03253042
NCT03253042已完成不适用

Immediate and Chronic Effects of Whole-Body Vibration on Neuromuscular Performance and Postural Control in Elderly: A Randomized Controlled Trial

Universidade Federal do Rio Grande do Norte2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Change in Muscle Performance measured through isokinetic dynamometer

研究概览

简要总结

The purpose of this study is to analyze the immediate and chronic effects of an exercise protocol on the vibration platform on the functional and neuromuscular performance of lower limbs, postural control and life quality in healthy elderly.

详细描述

The research is a randomized controlled trial that will be developed at the Laboratório de Análise da Performance Muscular (LAPERN) of the Physiotherapy Department of the Federal University of Rio Grande do Norte (UFRN). The population of the present study will be formed by elderly individuals living in the city of Natal / RN, aged between 65 and 75 years, of both sexes, without distinction of race, education and marital status. The research sample will be of a non-probabilistic type, in which these will be allocated randomly into two distinct groups: placebo group (GP) and experimental group (GE). This research was submitted to the Research Ethics Committee (CEP) for UFRN through the national interface Plataforma Brasil. The present research contemplates the ethical aspects based on Resolution 466/2012 of the National Health Council (CNS) and the Declaration of Helsinki for research with humans. In addition, the survey will be recorded in Clinicals Trial. All data will be recorded in a database of the laboratory under confidentiality and can only be handled by the responsible researchers. The study will only begin after the issuance of the referent opinion approving the project. All subjects will be duly informed and instructed regarding the scheduled procedures, which will only be executed after reading, accepting and signing the Term of Free and Informed Consent (TFIC). After approval by the Research Ethics Committee, following resolution 466/2012, a pilot study was carried out aiming at the adequacy of all the research procedures, as well as the training of the researchers involved. Initially the research will begin with the selection of the sample according to the inclusion criteria descried elsewhere. The evaluation will be scheduled by telephone contact. Following this, the volunteers will receive the TFIC for reading and due signature. The data collection process will take place in four stages: (1) initial evaluation, (2) sample allocation (3) application of exercise program and (4) reevaluations. The evaluations will be composed by the dynamometric analysis associated with EMG (electromyography), functional performance and postural control analysis. The volunteers will be allocated randomly into 2 groups: placebo group (with the platform off) or experimental group (with the platform set at a frequency of 40 Hz and amplitude of 4 mm). Both will participate in a program of exercises in the platform, consisting of a static bipodal squat at 40 ° of knee flexion, with 4 sets of 1.5 min, with a rest interval of 1 minute. Immediately after the first session, 4 and 8 weeks of training, the volunteers will be submitted to the new evaluations, with the same procedures of the initial evaluation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 75 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both genders;
  • Exhibiting ankle, hip and knee joint integrity of the non-dominant limb;
  • No history of muscle or joint injuries in the assessed limb in the last 6 months, or neurological, visual and/or non-corrected auditory impairments;
  • Do not have metallic implants in the lower limbs;
  • Do not have decompensated and / or untreated cardiovascular diseases;
  • Do not have advanced osteoporosis;
  • Do not have neurodegenerative diseases;
  • Do not have vestibular disorders;
  • Do not have uncorrected visual or hearing deficits.

排除标准

  • Elderly classified as very active or active;
  • Report cardiac and / or respiratory discomfort, nausea, vertigo and pain during during the evaluations and exercise sessions;
  • Do not understand and do not correctly perform the commands offered in the assessment and / or intervention protocols;
  • Miss 2 consecutive sessions during the exercise program.

研究组 & 干预措施

WBV exercise program

Experimental

8-week exercise program associated with the vibratory platform. Each exercise session will consist of 4 series of an isometric half-squat exercise with 1 minute and a half of duration and a rest interval of 1 minute. The vibratory platform will be connected at the beginning of each series, set at a vibration frequency of 40 Hertz (Hz) and peak-to-peak amplitude of 4 millimeters (mm) resulting in a peak acceleration of 128 ms2 (12.8 g). This should provide the equivalent of 3600 vertical vibrations, totaling 14400 vibrations per training session.

干预措施: WBV exercise program (Other)

Sham WBV exercise program

Sham Comparator

8-week exercise program in which each session will consist of 4 series of an isometric half-squat exercise with 1 minute and a half of duration and a rest interval of 1 minute. The vibratory platform will remain off at all sessions. A device will be attached to the side of the platform in order to produce a sound, similar to the sound produced by the vibrating platform when it is in operation.

干预措施: Sham WBV exercise program (Other)

结局指标

主要结局

Change in Muscle Performance measured through isokinetic dynamometer

时间窗: Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.

The muscle performance will be measured through isokinetic dynamometry and the variables analyzed will be peak torque normalized for body weight, average power, total work and time to peak torque.

次要结局

  • Change in Muscle activation measured through surface electromyography(Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.)
  • Change in Functional mobility measured through Timed up and Go test(Baseline, after 4 and 8 weeks of the beginning of exercise program.)
  • Change in Balance measured through baropodometry(Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.)
  • Change in Quality of life measured through SF-36 questionnaire(Baseline, after 4 and 8 weeks of the beginning of exercise program.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jamilson Simões Brasileiro

Associeted Professor and Researcher

Universidade Federal do Rio Grande do Norte

研究点 (2)

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