Bone DensityNCT06644469
Whole Body Vibration in Middle Aged Men
A study testing Dynatronics VF5 Model vibration platform in people with Bone Density and Muscle Weakness, run by Jouf University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Density, Muscle Weakness
- What is being tested?
- Dynatronics VF5 Model vibration platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Oct 2024to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants unable to stand on the WBV platform
- Participants with conditions contraindicating vibration therapy
- Participants participating in other clinical trials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
prince Mutaib bin Abdulaziz hospital
Sakakah, Aljouf, 77634
Khalid Alrwaily Mr, BPT, +966543944811, K.Alrwaily@moh.edu.sa
Fahad Alanazi Dr Assitant professor, PhD
About this study
Official title: 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.
- Conditions
- Bone Density, Muscle Weakness
- Being tested
- Dynatronics VF5 Model vibration platform, Placebo Dynatronics VF5 Model vibration platform
- Keywords
- Pilot Study, Bone Density, Vibration Therapy, Vitamin D, Muscle Strength
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynatronics VF5 Model vibration platformDevice
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.
Placebo Dynatronics VF5 Model vibration platformDevice
Placebo intensity with vertical vibration of 0.2 mm
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Dynatronics VF5 Model vibration platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Density
Changes in BMD (measured by DXA scanner),
Measured: 8 weeks
Grip Strength
hand grip strength (measured by a hand-held dynamometer)
Measured: 8 weeks
Vitamin D
Vitamin D levels (measured by high-performance liquid chromatography).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DensityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jouf University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahad Alanazi, Jouf University
- Investigators
- Fahad Alanazi, PhD, Principal investigator, Jouf University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644469
- Sponsor's protocol ID
- JoufU
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole-Body Vibration on Bone Mineral Density, Hand Grip Strength, and Vitamin D Levels in Middle-Aged Men: a Preliminary Clinical Trial
- ClinicalTrials.gov ID
- NCT06644469
- Acronym / sponsor ID
- JoufU
- Conditions
- Bone Density, Muscle Weakness
- Keywords
- Pilot Study, Bone Density, Vibration Therapy, Vitamin D, Muscle Strength
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Jouf UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group with placebo vibration therapy | Placebo comparator | Device: Placebo Dynatronics VF5 Model vibration platformParticipants will perform the same activities as the experimental group, but with a vertical displacement of 0.22 mm, deemed therapeutically insufficient. |
| Experimental Group | Experimental | Device: Dynatronics VF5 Model vibration platformParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Participants unable to stand on the WBV platform
- Participants with conditions contraindicating vibration therapy
- Participants participating in other clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynatronics VF5 Model vibration platformThe 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. | Device | Experimental Group |
| Placebo Dynatronics VF5 Model vibration platformPlacebo intensity with vertical vibration of 0.2 mm | Device | Control Group with placebo vibration therapy |
Primary outcome
Bone Density
Time frame: 8 weeks
Changes in BMD (measured by DXA scanner),
Grip Strength
Time frame: 8 weeks
hand grip strength (measured by a hand-held dynamometer)
Vitamin D
Time frame: 8 weeks
Vitamin D levels (measured by high-performance liquid chromatography).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fahad Alanazi, PhD principal investigator
Jouf University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynatronics VF5 Model vibration platform in people with Bone Density and Muscle Weakness, run by Jouf University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fahad Alanazi, PhD (00966503409217, Fsalenezi@ju.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Density (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.