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

Immediate and Chronic 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 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.

Study Overview

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

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) 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.

• Study Type: Interventional
• Enrollment (Actual): 44
• 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;
• Miss 2 consecutive sessions during the exercise program.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: WBV exercise program; 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.	Other: WBV exercise program; The intervention will consist of a 8-week whole-body vibration exercise program 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 program; 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.	Other: Sham WBV exercise program; The intervention will consist of a 8-week exercise program, 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 Muscle Performance measured through isokinetic dynamometer	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.	Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Muscle activation measured through surface electromyography	Measured by surface electromyography	Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.
Change in Balance measured through baropodometry	Measured by 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	measured by SF-36 questionnaire score	Baseline, after 4 and 8 weeks of the beginning of exercise program.
Change in Functional mobility measured through Timed up and Go test	measured by Timed up and Go test time	Baseline, after 4 and 8 weeks of the beginning of exercise program.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ACTUAL): March 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (ACTUAL): August 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

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

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