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

NCT ID: NCT06927882

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-15
• Study Completion Date: 2025-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

WBV Therapy Group

Intervention Type: 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.

Control

Intervention Type: OTHER

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo Group:

Intervention Type: 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 Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Control

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jouf University

OTHER

Sponsor Role: lead

Responsible Party

Fahad Alanazi

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Fahad Alanazi, PhD

Role: CONTACT

Fsalenezi@ju.edu.sa

+966503409217

Other Identifiers

JoufU1

Identifier Type: -

Identifier Source: org_study_id