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

Sponsor
Universidade Federal do Rio Grande do Norte (Other)
Overall Status
Completed
CT.gov ID
NCT03253042
Collaborator
(none)
44
1
2
19
2.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: WBV exercise program
  • Other: Sham WBV exercise program
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Immediate and Chronic Effects of Whole-Body Vibration on Neuromuscular Performance and Postural Control in Elderly: A Randomized Controlled Trial
Actual Study Start Date :
May 1, 2017
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Muscle Performance measured through isokinetic dynamometer [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.

Secondary Outcome Measures

  1. 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.]

    Measured by surface electromyography

  2. Change in Balance measured through baropodometry [Baseline, immediately after the intervention protocol and after 4 and 8 weeks of the beginning of exercise program.]

    Measured by baropodometry

  3. Change in Quality of life measured through SF-36 questionnaire [Baseline, after 4 and 8 weeks of the beginning of exercise program.]

    measured by SF-36 questionnaire score

  4. Change in Functional mobility measured through Timed up and Go test [Baseline, after 4 and 8 weeks of the beginning of exercise program.]

    measured by Timed up and Go test time

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Federal University of Rio Grande do Norte (UFRN) Natal RN Brazil 59140-840

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jamilson Simões Brasileiro, Associeted Professor and Researcher, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier:
NCT03253042
Other Study ID Numbers:
  • DL2017
First Posted:
Aug 17, 2017
Last Update Posted:
Apr 5, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jamilson Simões Brasileiro, Associeted Professor and Researcher, Universidade Federal do Rio Grande do Norte

Study Results

No Results Posted as of Apr 5, 2019