The Effect of Whole-body Vibration Training

February 17, 2020 updated by: HUI CHUN YANG, National Taipei University of Nursing and Health Sciences

The Effect of Whole-body Vibration Training on Biomarkers and Health Beliefs of Prefrail Older Adults: A Quasi-experimental Research

The whole-body vibration programme employed in this study partly improved the biomarkers and health beliefs of the prefrail community-dwelling older adults.

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.

Detailed Description

The experimental group participated in a 12-week whole-body vibration training that conducted 3 times per week, with 5-min continuous vibration at 12-Hz frequency and 3-mm amplitude each time

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.
42

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

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

65 years to 99 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age of 65 years or older and living in a community
  • Full consciousness and able to communicate verbally
  • No severe cognitive disorder

Exclusion Criteria:

  • Impaired mobility after recent surgery
  • Major illness such as cancer
  • Severe hearing impairment and inability to fully understand and follow instructions

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Experimental: whole-body vibration training
a 12-week whole-body vibration training that conducted 3 times per week, with 5-min continuous vibration at 12-Hz frequency and 3-mm amplitude each time.
Device: whole-body vibration training
The experimental group participated in a 12-week whole-body vibration training that was conducted 3 times per week, with 5-min continuous vibration at 12-Hz frequency and 3-mm amplitude each time. The control group were provided home DVDs on resistance exercise and manuals for preventing frailty

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
Pretest and posttest results of the experimental and control groups for Grip strength
Time Frame: Change from baseline at 12 weeks (The experimental group participated training that was conducted 3 times per week, with 5-min continuous vibration)
Comparison of grip strength before and after 12 weeks of training
Change from baseline at 12 weeks (The experimental group participated training that was conducted 3 times per week, with 5-min continuous vibration)
Pretest and posttest results of the experimental and control groups for 15-foot walk test speed
Time Frame: Change from baseline at 12 weeks (The experimental group participated training that was conducted 3 times per week, with 5-min continuous vibration)
Comparison of 15-foot walk test speed before and after 12 weeks of training
Change from baseline at 12 weeks (The experimental group participated training that was conducted 3 times per week, with 5-min continuous vibration)
Pretest and posttest results of the experimental and control groups for One-leg standing test using the dominant leg with the eyes open
Time Frame: Change from baseline at 12 weeks (The experimental group participated training that was conducted 3 times per week, with 5-min continuous vibration)
Comparison of One-leg standing test with the eyes open before and after 12 weeks of training
Change from baseline at 12 weeks (The experimental group participated training that was conducted 3 times per week, with 5-min continuous vibration)
Pretest and posttest results of the experimental and control groups for Thirty-second chair stand test
Time Frame: Change from baseline at 12 weeks (The experimental group participated training that was conducted 3 times per week, with 5-min continuous vibration)
Comparison of Thirty-second chair stand test before and after 12 weeks of training
Change from baseline at 12 weeks (The experimental group participated training that was conducted 3 times per week, with 5-min continuous vibration)
Pretest and posttest results of the experimental and control groups for Two-minute step test
Time Frame: Change from baseline at 12 weeks (The experimental group participated training that was conducted 3 times per week, with 5-min continuous vibration)
Comparison of Two-minute step test before and after 12 weeks of training
Change from baseline at 12 weeks (The experimental group participated training that was conducted 3 times per week, with 5-min continuous vibration)
Pretest and posttest results of the experimental and control groups for Health beliefs
Time Frame: The twelfth week
Comparison of health beliefs before and after 12 weeks
The twelfth week

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
Summary of posttest ANCOVA of the experimental and control groups for biomarkers
Time Frame: The twelfth week
One-way ANCOVA was conducted using the groups as the independent variable and the pretest results and sex as covariate variables to assess the intervention effectiveness
The twelfth week
Summary of posttest ANCOVA of the experimental and control groups for health beliefs
Time Frame: The twelfth week
One-way ANCOVA was conducted using the groups as the independent variable and the pretest results and sex as covariate variables to assess the intervention effectiveness
The twelfth week

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.
National Taipei University of Nursing and Health Sciences

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.
March 18, 2016

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.
June 25, 2016

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.
June 25, 2016

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).
November 6, 2019

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.
February 17, 2020

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.
February 18, 2020

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.
February 18, 2020

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.
February 17, 2020

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.
February 1, 2020

More Information

Terms related to this study

Keywords

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.
  • 201510ES014

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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