Immediate Effects of Whole-Body Vibration on Neuromuscular Performance and Postural Control in Elderly

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

The purpose of this study is to analyze the immediate 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.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Performance and Balance
• Intervention / Treatment: Other: WBV exercise group; Other: Sham WBV exercise group

Detailed Description

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)reevaluation. The evaluations will be composed by the dynamometric analysis associated with EMG (electromyography) 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 perform a bout of exercise in the vibrating 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 exercise the volunteers will be submitted to a revaluation, with the same procedures of the initial evaluation.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RN
    • Natal, RN, Brazil, 59140-840
      • Federal University of Rio Grande do Norte (UFRN)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 75 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WBV exercise group; Subjects will perform an isometric semi-squat exercise associated with the vibratory platform. The exercise 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	Other: WBV exercise group; The intervention will consist of a half-squat isometric whole-body vibration exercise with the platform configured at a frequency of 40 Hz and peak-to-peak amplitude of 4 mm. The sessions will be held 2 times a week, consisting of 4 sets of 1 and a half minutes of exercise on the platform. Rest intervals of 1 minute between sets will be respected.
Sham Comparator: Sham WBV exercise group; Subjects will perform an isometric semi-squat exercise associated with the vibratory platform. The exercise 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.	Other: Sham WBV exercise group; The intervention will consist of as half-squat isometric exercise , but the 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in average power measured through isokinetic dynamometer	Measured through isokinetic dynamometry. The analyzed variable will be average power (in watts).	Baseline and immediately after the intervention protocol.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Muscle activation measured through surface electromyography	Measured by surface electromyography. The analyzed variable will be the amplitude of muscle activation (in microvolts).	Baseline and immediately after the intervention protocol.
Change in Balance measured through baropodometry	Measured by baropodometry. The analyzed variable will be the oscilation of center of pressure (in mm).	Baseline and immediately after the intervention protocol .
Change in peak torque normalized by body weight measured through isokinetic dynamometer	Measured through isokinetic dynamometry. The analyzed variable will be a combination of peak torque normalized by body weight (in percentage).	Baseline and immediately after the intervention protocol.
Change in total work measured through isokinetic dynamometer	Measured through isokinetic dynamometry. The analyzed variable will be total work (in joules).	Baseline and immediately after the intervention protocol.
Change in peak torque measured through isokinetic dynamometer	Measured through isokinetic dynamometry. The analyzed variable will be peak torque (in Newtons).	Baseline and immediately after the intervention protocol.

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio Grande do Norte
• Investigators: Principal Investigator: Daniel T Borges, MS, Universidade Federal do Rio Grande do Norte; Principal Investigator: Lidiane C Bulhões, Esp, Universidade Federal do Rio Grande do Norte

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2018
• Primary Completion (Actual): April 10, 2018
• Study Completion (Actual): May 10, 2018

Study Registration Dates

• First Submitted: November 19, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 29, 2017

Study Record Updates

• Last Update Posted (Actual): June 18, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Aging; Vibration; Torque
• Other Study ID Numbers: DL2017.2

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