Whole Body Vibration in Middle Aged Men

NCT06644469 | Not Yet Recruiting

• 1 other identifier: JoufU
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bone Density; Muscle Weakness

Keywords

Pilot Study; Bone Density; Vibration Therapy; Vitamin D; Muscle Strength

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Control Group with placebo vibration therapy

PLACEBO COMPARATOR

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

Experimental Group

EXPERIMENTAL

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

Interventions

Dynatronics VF5 Model vibration platform DEVICE

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.

Experimental Group

Placebo Dynatronics VF5 Model vibration platform DEVICE

Placebo intensity with vertical vibration of 0.2 mm

Control Group with placebo vibration therapy

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Jouf University: lead

Study Sites (1)

prince Mutaib bin Abdulaziz hospital

Sakakah, Aljouf, 77634, Saudi Arabia

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Fahad Alanazi, PhD

  Jouf University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fahad Alanazi, PhD

CONTACT

00966503409217; Fsalenezi@ju.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participants will be unaware of whether they are receiving vibration therapy, and the individual performing the assessment will be different from the one administering the treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: October 15, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 15, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

SA (1)