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

NCT06927882 | Not Yet Recruiting

• 1 other identifier: JoufU1
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cognitive Impairment; Balance; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Montreal Cognitive Assessment (MoCA) for Cognitive Function

  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

  6 months

Secondary Outcomes (3)

• Berg Balance Scale

  6 months

• • Quality of Life

  12 weeks

• Timed up and go test

  6 month

Study Arms (3)

WBV Therapy Group

EXPERIMENTAL

* 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.

Other: WBV Therapy Group; Other: Control

Placebo Group

PLACEBO COMPARATOR

• 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.

Other: Placebo Group:

Control Group

NO INTERVENTION

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

Interventions

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.

WBV Therapy Group

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.

Placebo Group

Control OTHER

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

WBV Therapy Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Jouf University: lead

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Fahad Alanazi, PhD

CONTACT

+966503409217; Fsalenezi@ju.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 15, 2025
• Study Start: November 15, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11