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CompletedNCT03253042Updated Apr 5, 2019

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

An interventional study of WBV exercise program and Sham WBV exercise program in Neuromuscular Performance and Balance, sponsored by Universidade Federal do Rio Grande do Norte. Completed at 1 site in Brazil. Open to participants aged 65 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-05.

Sponsored by Universidade Federal do Rio Grande do Norte · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
65 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 350 studies in Motor Activity with a site in Brazil — 41 open to participants now, 52 under way, none of them phase 3. Motor Activity · Brazil.

Enrollment
164th of 328
44 · median 44
Started
2017
with 37 others
No phase
296 of 350
37 open now
Registered
173rd of 350
by date

Among the 350 studies in Motor Activity with a site in Brazil, this one is the 164th largest by enrollment of the 328 interventional ones that give a count, is one of 38 that started in 2017, is one of 296 with no phase, and was the 173rd registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

41 of the 350 studies in Motor Activity with a site in Brazil are open now. Recruiting first, the newest first:

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All 41 open studies →

A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 65 Years to 75 Years · all sexes · healthy volunteers too.

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02

Study summary

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.

Read the 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.

03

Conditions studied

  • Neuromuscular Performance and Balance

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Keywords

  • Exercise
  • Vibration
  • Torque
  • Aging
04

Who can participate

Ages eligible
65 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherWBV 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.

  • OtherSham 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.

06

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. Change in Muscle activation measured through surface electromyography

    Measured by surface electromyography

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

  2. Change in Balance measured through baropodometry

    Measured by baropodometry

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

  3. Change in Quality of life measured through SF-36 questionnaire

    measured by SF-36 questionnaire score

    Time frame: Baseline, after 4 and 8 weeks of the beginning of exercise program.

  4. Change in Functional mobility measured through Timed up and Go test

    measured by Timed up and Go test time

    Time frame: Baseline, after 4 and 8 weeks of the beginning of exercise program.

07

Study locations

1 site
  • Federal University of Rio Grande do Norte (UFRN)
    Natal, RN 59140-840, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2017 to primary completion in Mar 2018, 10 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 10 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 19, 2017
First posted
Aug 17, 2017
StartActual
May 1, 2017
Primary completionActual
Mar 1, 2018
CompletionActual
Dec 1, 2018
Last update
Apr 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03253042
Lead sponsor
Universidade Federal do Rio Grande do Norte
Responsible party
Jamilson Simões Brasileiro (Associeted Professor and Researcher, Universidade Federal do Rio Grande do Norte) — Principal investigator
First posted
Aug 17, 2017
Start date
May 1, 2017
Primary completion
Mar 1, 2018
Completion
Dec 1, 2018
Last update
Apr 5, 2019

Study contacts

Daniel T Borges, MD
principal investigator · Universidade Federal do Rio Grande do Norte
Lidiane C Correia, Esp
principal investigator · Universidade Federal do Rio Grande do Norte

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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