Whole Body Vibration in Middle Aged Men

Effects of Whole-Body Vibration on Bone Mineral Density, Hand Grip Strength, and Vitamin D Levels in Middle-Aged Men: a Preliminary Clinical Trial

This study aims of this clinical trial is to evaluate the effect of an 8-week Whole Body Vibration (WBV) intervention on Bone Mineral Density (BMD), hand grip strength, and vitamin D levels in middle-aged men. Findings from this study will contribute to understanding whether WBV is a viable alternative to conventional exercise, especially for those with limitations in physical activity.

Study Objectives:

• Primary Objective: To assess the effectiveness of an 8-week WBV intervention in improving BMD, hand grip strength, and vitamin D levels compared to a placebo intervention.

Study Overview

• Status: Not yet recruiting
• Conditions: Muscle Weakness; Bone Density
• Intervention / Treatment: Device: Placebo Dynatronics VF5 Model vibration platform; Device: Dynatronics VF5 Model vibration platform

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fahad Alanazi, PhD; Phone Number: 00966503409217; Email: Fsalenezi@ju.edu.sa

Study Locations

• Saudi Arabia
  • Aljouf
    • Sakaka, Aljouf, Saudi Arabia, 77634
      • prince Mutaib bin Abdulaziz hospital
      • Contact: Khalid Alrwaily Mr, BPT; Phone Number: +966543944811; Email: K.Alrwaily@moh.edu.sa
      • Contact: Fahad Alanazi Dr Assitant professor, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male participants aged 50 years or older
• Participants with physical activity or exercise program involvement
• Participants with no history of serious medical conditions such as tumors, fractures, epilepsy, cardiac disease, or stroke within the past year.
• Participants must be non-smokers and not receiving hormone or calcium supplement therapy

Exclusion Criteria:

• Participants unable to stand on the WBV platform
• Participants with conditions contraindicating vibration therapy
• Participants participating in other clinical trials

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group with placebo vibration therapy; Participants will perform the same activities as the experimental group, but with a vertical displacement of 0.22 mm, deemed therapeutically insufficient.	Device: Placebo Dynatronics VF5 Model vibration platform; Placebo intensity with vertical vibration of 0.2 mm
Experimental: Experimental Group; Participants will undergo an 8-week WBV therapy program using a Dynatronics VF5 Model vibration platform. Each session will last 4 minutes, with vibration frequencies progressively increased from 25 Hz to 40 Hz without rest intervals.	Device: Dynatronics VF5 Model vibration platform; The Dynatronics VF5 Model vibration platform is a specialized therapeutic device designed for rehabilitation and wellness applications. Utilizing advanced vibration technology, it provides whole-body vibration therapy that can enhance muscle strength, improve flexibility, and promote overall physical well-being. The platform features adjustable frequency and amplitude settings, allowing customization based on individual needs. Its user-friendly interface and robust, durable design make it suitable for both clinical and mobile therapy settings. Additionally, the compact and portable nature of the VF5 facilitates easy storage and transport, while safety features such as non-slip surfaces ensure user protection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Density	Changes in BMD (measured by DXA scanner),	8 weeks
Grip Strength	hand grip strength (measured by a hand-held dynamometer)	8 weeks
Vitamin D	Vitamin D levels (measured by high-performance liquid chromatography).	8 weeks

Collaborators and Investigators

• Sponsor: Jouf University
• Investigators: Principal Investigator: Fahad Alanazi, PhD, Jouf University

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Vitamin D; Muscle Strength; Bone Density; Pilot Study; Vibration Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• Other Study ID Numbers: JoufU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

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