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

Jouf University

Status: Not yet enrolling

Conditions: Balance; Cognitive Impairment; Quality of Life

Treatments: Other: Control; Other: WBV Therapy Group; Other: Placebo Group:

Study type: Interventional

Funder types: Other

Identifiers

NCT06927882

JoufU1

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups, including a placebo group

WBV Therapy Group

Experimental group

Description:

* 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.

Treatment:

Other: WBV Therapy Group

Other: Control

Placebo Group

Placebo Comparator group

Description:

• 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.

Treatment:

Other: Placebo Group:

Control Group

No Intervention group

Description:

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