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NCT Number: NCT06927882

Effects of Whole Body Vibration Therapy on Cognitive Function, Balance, and Quality of Life in Older Adults With Mild Cognitive Impairment

This is a double-blind, randomized controlled trial comparing WBV therapy with a placebo intervention and standard care. A total of 150 participants will be recruited and investigated from Prince Mutib Hospital. Participants will be randomly allocated to one of three groups: WBV therapy, placebo (non-vibrating platform), or control (standard care). The study duration will be 12 weeks, with assessments conducted at baseline, post-intervention (12 weeks), and at a 6-month follow-up.

Protocol Parameters Summary

* Session Frequency: 3 times per week. * Session Duration: 25 minutes per session. * Vibration Frequency: 30 Hz. * Amplitude: 1-2 mm. * Program Duration: 12 weeks.

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Key information

Conditions

Cognitive Impairment Balance Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Quality of Life

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 60 years and older.
  • Diagnosed with mild cognitive impairment (Montreal Cognitive Assessment (MoCA) score of 18-25). One point is added if years of education are less than 12 years[2].
  • Able to stand independently or with minimal assistance.
  • No contraindications for WBV therapy or exercise.

Exclusion criteria

  • Diagnosis of dementia.
  • Severe musculoskeletal or neurological disorders.
  • Implanted electronic medical devices (e.g., pacemaker).
  • Inability to comprehend study instructions.

Treatment and study plan

WBV Therapy Group

Other
  • Frequency: 3 sessions per week for 12 weeks.
  • Duration: 25 minutes per session.
  • Vibration Parameters: Participants will undergo whole body vibration therapy at a frequency of 30 Hz, for 25 minutes per session, 3 times a week, with an amplitude of 1-2 mm, over a duration of 12 weeks.

Placebo Group:

Other
  • Participants will stand on a non-vibrating platform and perform similar static and dynamic exercises for the same duration. The platform will mimic the active intervention's noise and display settings to maintain blinding.

Control

Other

Only assessment at baseline, after 12 weeks and 6 months.

Primary outcomes

  1. Montreal Cognitive Assessment (MoCA) for Cognitive Function

    Time frame: 6 months

    Assessed using the standard Arabic version of the Montreal Cognitive Assessment (MoCA) at baseline, 12 weeks, and 6 months. The tool is a reliable and valid instrument to detect MCI among the elderly. The maximum score is 0-30, with higher scores indicating better cognitive functioning. A score below 26 typically suggests cognitive impairment. These tests evaluate changes in executive function, attention, and overall cognitive ability. The investigator will use the standard Arabic version used among community dwelling Saudi Arabians population with changes in some word to make it suitable for the Arabic speaking Saudi Arabian population

Secondary outcomes

  1. Berg Balance Scale

    Time frame: 6 months

    Balance was assessed using the Berg Balance Scale (BBS), a validated and reliable 14-item tool for measuring functional balance. Each item was scored from 0 to 4, with a maximum total of 56. Higher scores reflect better balance performance. The Arabic-translated version, previously validated for clinical use, was administered at baseline, 12 weeks, and 6 months.

  2. • Quality of Life

    Time frame: 12 weeks

    Health-related quality of life (HRQoL) was measured using the Arabic version of the Short Form-36 Health Survey (SF-36). This self-reported tool comprises 36 items that assess eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health. Scores for each domain range from 0 to 100, with higher scores indicating better health status. The Arabic version has been culturally adapted and validated for use among Arabic-speaking populations, ensuring both linguistic and conceptual equivalence.

  3. Timed up and go test

    Time frame: 6 month

    Mobility and fall risk were assessed using the Timed Up and Go (TUG) test. Participants were instructed to stand from a seated position, walk 3 meters, turn around, return, and sit down. The time to complete the task was measured in seconds. Higher times indicate reduced mobility and increased fall risk. A TUG time greater than 13.5 seconds is considered indicative of elevated fall risk.

Study contacts

Contact information is provided by the study sponsor or research team.

Fahad Alanazi, PhD

CONTACT

[email protected]

+966503409217

Sponsors and collaborators

Lead sponsor

Jouf University

Other

Registry information

Official study title

Effects of Whole Body Vibration Therapy on Cognitive Function, Balance, and Quality of Life in Older Adults With Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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