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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Cognitive Impairment; Balance
• Intervention / Treatment: Other: WBV Therapy Group; Other: Control; Other: Placebo Group:

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fahad Alanazi, PhD; Phone Number: +966503409217; Email: Fsalenezi@ju.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WBV Therapy Group; 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; 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: Control; Only assessment at baseline, after 12 weeks and 6 months.
Placebo Comparator: Placebo Group; • 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: • 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.
No Intervention: Control Group; Only assessment at baseline, after 12 weeks and 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale	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.	6 months
• Quality of Life	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.	12 weeks
Timed up and go test	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.	6 month

Collaborators and Investigators

• Sponsor: Jouf University

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2025
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: April 6, 2025
• First Submitted That Met QC Criteria: April 12, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: JoufU1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No