BiomarkersNCT04273308
The Effect of Whole-body Vibration Training
A study testing whole-body vibration training in people with Biomarkers, run by National Taipei University of Nursing and Health Sciences.
Trial summary
The whole-body vibration programme employed in this study partly improved the biomarkers and health beliefs of the prefrail community-dwelling older adults. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Biomarkers
- What is being tested?
- whole-body vibration training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 18 Mar 2016to 25 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age of 65 years or older and living in a community
- Full consciousness and able to communicate verbally
- No severe cognitive disorder
Who cannot join
- Impaired mobility after recent surgery
- Major illness such as cancer
- Severe hearing impairment and inability to fully understand and follow instructions
About this study
Official title: 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.
Read the 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
- Conditions
- Biomarkers
- Being tested
- whole-body vibration training
- Keywords
- older adults, community, frailty biomarkers, health belief, prefrailty, quasi-experimental design, whole-body vibration training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole-body vibration trainingDevice
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
| Study group | Role | What they receive |
|---|---|---|
| whole-body vibration training | Experimental | 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. Receives: Device: whole-body vibration training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pretest and posttest results of the experimental and control groups for Grip strength
Comparison of grip strength before and after 12 weeks of training
Measured: 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
Comparison of 15-foot walk test speed before and after 12 weeks of training
Measured: 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
Comparison of One-leg standing test with the eyes open before and after 12 weeks of training
Measured: 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
Comparison of Thirty-second chair stand test before and after 12 weeks of training
Measured: 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
Comparison of Two-minute step test before and after 12 weeks of training
Measured: 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
Comparison of health beliefs before and after 12 weeks
Measured: The twelfth week
Secondary outcomes (2)
Summary of posttest ANCOVA of the experimental and control groups for biomarkers
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
Measured: The twelfth week
Summary of posttest ANCOVA of the experimental and control groups for health beliefs
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
Measured: The twelfth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start18 Mar 2016
- Primary completion25 Jun 2016
- Study completion25 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiomarkersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HUI CHUN YANG, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273308
- Sponsor's protocol ID
- 201510ES014
- Status last verified
- Feb 2020
- First submitted
- 6 Nov 2019
- Last updated
- 18 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whole-body Vibration Training on Biomarkers and Health Beliefs of Prefrail Older Adults: A Quasi-experimental Research
- ClinicalTrials.gov ID
- NCT04273308
- Acronym / sponsor ID
- 201510ES014
- Conditions
- Biomarkers
- Keywords
- older adults, community, frailty biomarkers, health belief, prefrailty, quasi-experimental design, whole-body vibration training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 18 Mar 2016 (actual)
- Primary completion
- 25 Jun 2016 (actual)
- Study completion
- 25 Jun 2016 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The whole-body vibration programme employed in this study partly improved the biomarkers and health beliefs of the prefrail community-dwelling older adults.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| whole-body vibration training | Experimental | Device: whole-body vibration traininga 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. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age of 65 years or older and living in a community
- Full consciousness and able to communicate verbally
- No severe cognitive disorder
Key exclusion criteria (3 listed)
- Impaired mobility after recent surgery
- Major illness such as cancer
- Severe hearing impairment and inability to fully understand and follow instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole-body vibration trainingThe 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 | Device | whole-body vibration training |
Primary outcome
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
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
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
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
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
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
2 secondary outcomes
Summary of posttest ANCOVA of the experimental and control groups for biomarkers
Time frame: The twelfth week
Summary of posttest ANCOVA of the experimental and control groups for health beliefs
Time frame: The twelfth week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing whole-body vibration training in people with Biomarkers, run by National Taipei University of Nursing and Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.