- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06629298
Effects of Stochastic Whole-body Vibration Training on Balance and Executive Functions
Immediate Effects of Stochastic Whole-body Vibration Training on Balance and Executive Functions: A Randomized Controlled Trial
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bern, Switzerland, 3012
- Institut für Psychologie, Arbeits- und Organisationspsychologie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy
Exclusion Criteria:
- 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
- Cardiovascular problems
- Balance disorders
- Red-green color blindness
- Intensive training within 24 hours prior to the assessment.
- Use of central nervous system medications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 5 Hertz Whole-Body Vibration Intervention
Three 1-minute sessions of stochastic whole-body vibration (SR-WBV) training with 1-minute breaks at 5 Hz
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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. |
|
Sham Comparator: 2 Hertz Whole-Body Vibration Intervention
Three 1-minute sessions of stochastic whole-body vibration (SR-WBV) training with 1-minute breaks at 2 Hz
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sense of Balance (Change from Baseline)
Time Frame: 19 min before and 19 min after the intervention (immediate effects)
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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. |
19 min before and 19 min after the intervention (immediate effects)
|
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Balance (Change from Baseline)
Time Frame: Immediately before and 13 min after the intervention (immediate effects)
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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) |
Immediately before and 13 min after the intervention (immediate effects)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Executive functions (Shifting) (Change from Baseline)
Time Frame: 10 min before and 8 min after the intervention (immediate effects)
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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) |
10 min before and 8 min after the intervention (immediate effects)
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Executive functions (Updating) (Change from Baseline)
Time Frame: 18 min before and immediately after the intervention (immediate effects)
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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) |
18 min before and immediately after the intervention (immediate effects)
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Executive functions (Inhibition) (Change from Baseline)
Time Frame: 7 min before and 11 min after the intervention (immediate effects)
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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) |
7 min before and 11 min after the intervention (immediate effects)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Achim Elfering, Prof. Dr. phil. nat., University of Bern
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019-07-00005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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