NCT06629298

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

October 3, 2024

Last Update Submit

October 16, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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)

    Immediately before and 13 min after the intervention (immediate effects)

Secondary Outcomes (3)

  • Executive functions (Shifting) (Change from Baseline)

    10 min before and 8 min after the intervention (immediate effects)

  • Executive functions (Updating) (Change from Baseline)

    18 min before and immediately after the intervention (immediate effects)

  • Executive functions (Inhibition) (Change from Baseline)

    7 min before and 11 min after the intervention (immediate effects)

Study Arms (2)

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

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

Other: 2 Hz Stochastic Resonance Whole-Body Vibration Training

Interventions

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.

5 Hertz Whole-Body Vibration Intervention

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.

2 Hertz Whole-Body Vibration Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut für Psychologie, Arbeits- und Organisationspsychologie

Bern, 3012, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 36793620BACKGROUND

Study Officials

  • Achim Elfering, Prof. Dr. phil. nat.

    University of Bern

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: One Experimental Group and one Control Group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2024

First Posted

October 8, 2024

Study Start

September 20, 2023

Primary Completion

October 20, 2023

Study Completion

October 20, 2023

Last Updated

October 18, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

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.

Locations