Effects of Whole Body Vibration on Autonomic Function in Healthy Young and Elderly

December 29, 2017 updated by: Helga Cecília Muniz de Souza, Universidade Federal de Pernambuco

Acute Effects of Whole Body Vibration on Autonomic Function in Healthy Young and Elderly

Aging causes anatomical and physiological changes in the cardiovascular system and autonomic function with decline in its maximum function. This study aimed to evaluate the acute effects of whole body vibration on cardiovascular system, autonomic function and heart variability in healthy young and elderly. The investigators' hypothesis is that whole body vibration has different effects in young and elderly.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil
        • Federal University of Pernambuco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elderly individuals aged between 60 and 80 years
  • Young individuals aged between 18 and 30 years
  • Able to walk without assistance
  • Good understanding to perform the proposed procedures
  • Sedentary or low active

Exclusion Criteria:

  • Body Mass Index (BMI) > 35Kg/m2
  • Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg (at rest)
  • Difficulty adapting to the whole body vibration
  • Smoking
  • Neuromuscular or degenerative disorders
  • Neurological diseases
  • Cardiopulmonary comorbidities
  • Cardiac arrhythmias
  • Osteoarticular disorders
  • Use of hormone replacement therapy
  • Use medications or supplements known to affect cardiovascular parameters
  • Labyrinthitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Young Group
Healthy young of both sexes between the ages of 18 and 30 years will perform a whole body vibration session
Other: Whole Body Vibration
A whole body vibration session will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 04 mm.
Experimental: Elderly Group
Healthy elderly of both sexes between the ages of 60 and 80 years will perform a whole body vibration session
Other: Whole Body Vibration
A whole body vibration session will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 04 mm.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Autonomic Function
Time Frame: Change from Baseline Heart rate variability at 5, 10, 15, 20 and 35 minutes
Heart rate variability will be assessed from 3-channel holter
Change from Baseline Heart rate variability at 5, 10, 15, 20 and 35 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sympathetic modulation
Time Frame: Change from Baseline Sympathetic modulation at 5, 10, 15, 20 and 35 minutes
Sympathetic modulation will be assessed from 3-channel holter
Change from Baseline Sympathetic modulation at 5, 10, 15, 20 and 35 minutes
Parasympathetic modulation
Time Frame: Change from Baseline Parasympathetic modulation at 5, 10, 15, 20 and 35 minutes
Parasympathetic modulation will be assessed from 3-channel holter
Change from Baseline Parasympathetic modulation at 5, 10, 15, 20 and 35 minutes
Sympathovagal Balance
Time Frame: Change from Baseline Sympathovagal balance at 5, 10, 15, 20 and 35 minutes
Sympathovagal Balance will be assessed from 3-channel holter
Change from Baseline Sympathovagal balance at 5, 10, 15, 20 and 35 minutes
Heart Rate
Time Frame: Change from Baseline Heart Rate at 5, 10, 15, 20 and 35 minutes
Non-invasive measures will be assessed from 3-channel holter
Change from Baseline Heart Rate at 5, 10, 15, 20 and 35 minutes
Blood pressure
Time Frame: Change from Baseline Blood pressure at 5, 10, 15, 20 and 35 minutes
Non-invasive measures of brachial blood pressure
Change from Baseline Blood pressure at 5, 10, 15, 20 and 35 minutes
Peripheral oxygen saturation
Time Frame: Change from Baseline Peripheral oxygen saturation at 5, 10, 15, 20 and 35 minutes
Non-invasive measures will be assessed from pulse oximeter
Change from Baseline Peripheral oxygen saturation at 5, 10, 15, 20 and 35 minutes
Adverse effects
Time Frame: Change from Baseline at 20 minutes
Adverse effects reported by volunteers
Change from Baseline at 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal de Pernambuco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WBV on autonomic function

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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