HealthyNCT06629298
Effects of Stochastic Whole-body Vibration Training on Balance and Executive Functions
A study testing 5Hz Stochastic Resonance Whole-Body Vibration Training and 2 Hz Stochastic Resonance Whole-Body Vibration Training in people with Healthy, run by University of Bern at 1 site in Switzerland.
Trial summary
Falls represent a significant financial burden, costing millions of dollars annually in Switzerland (SUVA, 2022). Good cognitive abilities and good balance represent modifiable protective factors against falls (Kurz, 2008). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 5Hz Stochastic Resonance Whole-Body Vibration Training and 2 Hz Stochastic Resonance Whole-Body Vibration Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Sep 2023to 20 Oct 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
Who cannot join
- Pregnancy
- The presence of osteosynthetic materials (e.g., screws, plates, wires)
- Joint problems (particularly in the knees, hips, and back)
- Musculoskeletal issues
- Disc herniation
- Rheumatism
Show all 11Show fewer
- Cardiovascular problems
- Balance disorders
- Red-green color blindness
- Intensive training within 24 hours prior to the assessment.
- Use of central nervous system medications
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Institut für Psychologie, Arbeits- und Organisationspsychologie
Bern, 3012
About this study
Official title: Immediate Effects of Stochastic Whole-body Vibration Training on Balance and Executive Functions: A Randomized Controlled Trial
Falls represent a significant financial burden, costing millions of dollars annually in Switzerland (SUVA, 2022). Good cognitive abilities and good balance represent modifiable protective factors against falls (Kurz, 2008). The present study investigates the impact of stochastic whole-body vibration training (SR-WBV) on executive functions and balance. To this end, participants were randomized into an intervention group or a control group. Participants in the intervention group underwent SR-WBV at a frequency of 5 Hertz (Hz), while participants in the control group underwent SR-WBV at 2 Hz. The training on an SRT Zeptor® Medical plus noise device consisted of three one-minute intervals of vibration, interspersed with one-minute rest periods. Data on executive functions (Updating, Shifting, Inhibition) and balance were collected before and after the intervention , complemented by subjective assessments of concentration and balance through questionnaires.
- Conditions
- Healthy
- Being tested
- 5Hz Stochastic Resonance Whole-Body Vibration Training, 2 Hz Stochastic Resonance Whole-Body Vibration Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5Hz Stochastic Resonance Whole-Body Vibration TrainingOther
Both the experimental group and the control group performed their training on an SRT Zeptor® Medical plus noise device (Frei Swiss AG, Zurich). The device featured two independent foot plates that vibrated stochastically in all three dimensions, resulting in multidimensional movement. During the training, participants were instructed to stand on the foot plates with both feet, keep their arms relaxed at their sides, maintain a slight bend in their knees, and focus their gaze on a fixation cross on the wall. Following the protocol used in Faes et al. (2018), each training session consisted of three series, each comprising one minute of vibration training followed by one minute of rest.
The vibration frequency for the intervention group was set at 5 Hz.
2 Hz Stochastic Resonance Whole-Body Vibration TrainingOther
Both the experimental group and the control group performed their training on an SRT Zeptor® Medical plus noise device (Frei Swiss AG, Zurich). The device featured two independent foot plates that vibrated stochastically in all three dimensions, resulting in multidimensional movement. During the training, participants were instructed to stand on the foot plates with both feet, keep their arms relaxed at their sides, maintain a slight bend in their knees, and focus their gaze on a fixation cross on the wall. Following the protocol used in Faes et al. (2018), each training session consisted of three series, each comprising one minute of vibration training followed by one minute of rest.
The vibration frequency for the intervention group was set at 2 Hz.
| Study group | Role | What they receive |
|---|---|---|
| 5 Hertz Whole-Body Vibration Intervention | Experimental | Three 1-minute sessions of stochastic whole-body vibration (SR-WBV) training with 1-minute breaks at 5 Hz Receives: Other: 5Hz Stochastic Resonance Whole-Body Vibration Training |
| 2 Hertz Whole-Body Vibration Intervention | Sham comparator | Three 1-minute sessions of stochastic whole-body vibration (SR-WBV) training with 1-minute breaks at 2 Hz Receives: Other: 2 Hz Stochastic Resonance Whole-Body Vibration Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sense of Balance (Change from Baseline)
Measured with subjective scale (sense of balance from 0 to 10)
How do you assess your personal sensations regarding muscles and joints (back pain, shoulder and neck pain, leg muscle pain, etc.) at this moment?
Please slide the scale for each aspect to the most appropriate level.
0 means no pain, and 10 means the most intense pain imaginable.
Measured: 19 min before and 19 min after the intervention (immediate effects)
Balance (Change from Baseline)
Measured with the modified star excursion balance test (m-SEBT). Higher values indicate better balance with 0cm being the minimum and ca. 100cm indicating very good balance, i.e. reach distance.
In this balance test, participants stand on one leg, while the range of motion of the other leg is measured in eight directions: anterior (ANT), posteromedial (PM), and posterolateral (PL).
(Duration: 5 min)
Measured: Immediately before and 13 min after the intervention (immediate effects)
Secondary outcomes (3)
Executive functions (Shifting) (Change from Baseline)
Measured with the Trail-Making Test B
For TMT B, participants were presented with circles filled with both numbers and letters. They were required to click the circles in ascending order, alternating between numbers and letters (e.g., 1, A, 2, B, 3, C). The practice task consisted of six circles, and the main test involved 24 circles. The processing time was measured in milliseconds.
Thus, higher scores in the Trail-Making Test B indicate lower shifting ability.
(Duration: 3 min)
Measured: 10 min before and 8 min after the intervention (immediate effects)
Executive functions (Updating) (Change from Baseline)
Measured with the Running Span-Task
Participants were presented with a series of letters of varying lengths (3 to 8 letters).
For each participant, both the total Running Span (sum of all correctly recalled target items) and the Running Span Score (sum of correctly recalled target items from sets that included at least one distractor) were calculated.
Thus, higher scores (MIN = 0) in the Running Span-Task indicate higher updating ability.
(Duration: 8 min)
Measured: 18 min before and immediately after the intervention (immediate effects)
Executive functions (Inhibition) (Change from Baseline)
Measured with the Stroop Test in milliseconds (Reaction Time)
The reaction times (in milliseconds) for all correctly identified incongruent items were subtracted from those for control items.
0 ms indicate no cognitive interference, i.e. maximal inhibitory control
Thus, higher scores in the Stroop Test indicate higher cognitive interference, i.e. poorer inhibitory control
(Duration: 2 min)
Measured: 7 min before and 11 min after the intervention (immediate effects)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start20 Sep 2023
- Primary completion20 Oct 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One Experimental Group and one Control Group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Achim Elfering, Prof. Dr. phil. nat., Study chair, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629298
- Sponsor's protocol ID
- 2019-07-00005
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon arrival, participants generated an individual ID, which was linked to their identity in a password-protected file for two weeks, during which they could request data deletion. After this period, the link was permanently removed, ensuring full anonymity. Only aggregated statistical analyses were conducted.
Publications
Faes Y, Rolli Salathe C, Herlig ML, Elfering A. Beyond physiology: Acute effects of side-alternating whole-body vibration on well-being, flexibility, balance, and cognition using a light and portable platform A randomized controlled trial. Front Sports Act Living. 2023 Jan 30;5:1090119. doi: 10.3389/fspor.2023.1090119. eCollection 2023.
PubMed 36793620
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Stochastic Whole-body Vibration Training on Balance and Executive Functions: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06629298
- Acronym / sponsor ID
- 2019-07-00005
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 8 Oct 2024 (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.
Falls represent a significant financial burden, costing millions of dollars annually in Switzerland (SUVA, 2022). Good cognitive abilities and good balance represent modifiable protective factors against falls (Kurz, 2008). The present study investigates the impact of stochastic whole-body vibration training (SR-WBV) on executive functions and balance. To this end, participants were randomized into an intervention group or a control group. Participants in the intervention group underwent SR-WBV at a frequency of 5 Hertz (Hz), while participants in the control group underwent SR-WBV at 2 Hz. The training on an SRT Zeptor® Medical plus noise device consisted of three one-minute intervals of vibration, interspersed with one-minute rest periods. Data on executive functions (Updating, Shifting, Inhibition) and balance were collected before and after the intervention , complemented by subjective assessments of concentration and balance through questionnaires.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- One Experimental Group and one Control Group
| Arm | Type | Receives |
|---|---|---|
| 5 Hertz Whole-Body Vibration Intervention | Experimental | Other: 5Hz Stochastic Resonance Whole-Body Vibration TrainingThree 1-minute sessions of stochastic whole-body vibration (SR-WBV) training with 1-minute breaks at 5 Hz |
| 2 Hertz Whole-Body Vibration Intervention | Sham comparator | Other: 2 Hz Stochastic Resonance Whole-Body Vibration TrainingThree 1-minute sessions of stochastic whole-body vibration (SR-WBV) training with 1-minute breaks at 2 Hz |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (11 listed)
- Pregnancy
- The presence of osteosynthetic materials (e.g., screws, plates, wires)
- Joint problems (particularly in the knees, hips, and back)
- Musculoskeletal issues
- Disc herniation
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 |
|---|---|---|
| 5Hz Stochastic Resonance Whole-Body Vibration TrainingBoth the experimental group and the control group performed their training on an SRT Zeptor® Medical plus noise device (Frei Swiss AG, Zurich). The device featured two independent foot plates that vibrated stochastically in all three dimensions, resulting in multidimensional movement. During the training, participants were instructed to stand on the foot plates with both feet, keep their arms relaxed at their sides, maintain a slight bend in their knees, and focus their gaze on a fixation cross on the wall. Following the protocol used in Faes et al. (2018), each training session consisted of three series, each comprising one minute of vibration training followed by one minute of rest. The vibration frequency for the intervention group was set at 5 Hz. | Other | 5 Hertz Whole-Body Vibration Intervention |
| 2 Hz Stochastic Resonance Whole-Body Vibration TrainingBoth the experimental group and the control group performed their training on an SRT Zeptor® Medical plus noise device (Frei Swiss AG, Zurich). The device featured two independent foot plates that vibrated stochastically in all three dimensions, resulting in multidimensional movement. During the training, participants were instructed to stand on the foot plates with both feet, keep their arms relaxed at their sides, maintain a slight bend in their knees, and focus their gaze on a fixation cross on the wall. Following the protocol used in Faes et al. (2018), each training session consisted of three series, each comprising one minute of vibration training followed by one minute of rest. The vibration frequency for the intervention group was set at 2 Hz. | Other | 2 Hertz Whole-Body Vibration Intervention |
Primary outcome
Sense of Balance (Change from Baseline)
Time frame: 19 min before and 19 min after the intervention (immediate effects)
Measured with subjective scale (sense of balance from 0 to 10) How do you assess your personal sensations regarding muscles and joints (back pain, shoulder and neck pain, leg muscle pain, etc.) at this moment? Please slide the scale for each aspect to the most appropriate level. 0 means no pain, and 10 means the most intense pain imaginable.
Balance (Change from Baseline)
Time frame: Immediately before and 13 min after the intervention (immediate effects)
Measured with the modified star excursion balance test (m-SEBT). Higher values indicate better balance with 0cm being the minimum and ca. 100cm indicating very good balance, i.e. reach distance. In this balance test, participants stand on one leg, while the range of motion of the other leg is measured in eight directions: anterior (ANT), posteromedial (PM), and posterolateral (PL). (Duration: 5 min)
3 secondary outcomes
Executive functions (Shifting) (Change from Baseline)
Time frame: 10 min before and 8 min after the intervention (immediate effects)
Executive functions (Updating) (Change from Baseline)
Time frame: 18 min before and immediately after the intervention (immediate effects)
Executive functions (Inhibition) (Change from Baseline)
Time frame: 7 min before and 11 min after the intervention (immediate effects)
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 Oct 2024.
- Background: PubMed 36793620Faes Y, Rolli Salathe C, Herlig ML, Elfering A. Beyond physiology: Acute effects of side-alternating whole-body vibration on well-being, flexibility, balance, and cognition using a light and portable platform A randomized controlled trial. Front Sports Act Living. 2023 Jan 30;5:1090119. doi: 10.3389/fspor.2023.1090119. eCollection 2023.
- Individual participant dataSharing planned: No. Upon arrival, participants generated an individual ID, which was linked to their identity in a password-protected file for two weeks, during which they could request data deletion. After this period, the link was permanently removed, ensuring full anonymity. Only aggregated statistical analyses were conducted.
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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.
Achim Elfering, Prof. Dr. phil. nat. study chair
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5Hz Stochastic Resonance Whole-Body Vibration Training and 2 Hz Stochastic Resonance Whole-Body Vibration Training in people with Healthy, run by University of Bern at 1 site in Switzerland.
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 1 inclusion and 11 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 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Sense of Balance (Change from Baseline) (time frame: 19 min before and 19 min after the intervention (immediate effects)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06629298, which also lists 1 linked publication.
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 Oct 2024.