Bone DensityNCT06222931
Effects of Whole Body Vibration in Different Devices on Bone and Muscle Mass in Postmenopausal Women
A study testing Triplanar vibrating platform and Side-alternating vibrating platform in people with Bone Density and Muscles, run by Universidade Estadual do Norte do Parana at 1 site in Brazil.
Trial summary
Postmenopausal women suffer from a series of negative health factors, such as decreased bone and muscle mass and physical performance, increasing the risk of falls and decreasing quality of life. Therefore, intervention strategies aimed at mitigating these factors are essential. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Density, Muscles, Physical Functional Performance
- What is being tested?
- Triplanar vibrating platform and Side-alternating vibrating platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jan 2024to 26 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being postmenopausal (without menstruating for at least 12 months);
- Not performing physical exercise systematically for at least 6 months;
- Not needing assistance to carry out daily tasks;
- Do not present serious cognitive problems that make it impossible to understand simple commands;
- Do not have serious dysfunctions or implants in the spine, hips or lower limbs;
- Not have neurological diseases or diseases that affect bone metabolism;
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- Do not have vascular diseases, arrhythmia, use a pacemaker, suffer from epilepsy or seizures;
- No diseases/problems that affect the retina;
- Do not present severe labyrinthitis or vertigo;
- Not using medication/supplements to increase bone and/or muscle mass for at least 6 months;
- Have not undergone cancer treatment in the last 5 years.
Who cannot join
- Withdraw from participating in the study for any reason;
- Present adverse events during interventions that cannot be controlled.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Estadual do Norte do Paraná
Jacarezinho, Paraná, 86400-000
About this study
Official title: Effects of Whole Body Vibration in Different Devices on Bone and Muscle Mass, Physical Performance, Quality of Life and Falls in Postmenopausal Women
Postmenopausal women suffer from a series of negative health factors, such as decreased bone and muscle mass and physical performance, increasing the risk of falls and decreasing quality of life. Therefore, intervention strategies aimed at mitigating these factors are essential. A technique that has been studied and can reverse these factors is whole-body vibration (WBV), however studies present contradictory results and the main confounding factor appears to be related to the type of vibration (synchronous or side-alternating). Therefore, the primary objective of this project is to verify the effects of 12 months of whole-body vibration on different devices on bone mineral density measurements in postmenopausal women. As a secondary objective, the effects on muscle mass, physical performance, quality of life and falls will be verified. 127 postmenopausal women will participate in the study and will be randomized to: triplanar vibration (synchronous); side-alternating vibration; or false vibration. The interventions will last 12 months and will occur three times a week on non-consecutive days. The following assessments will be carried out at baseline, 6-months and 12-months: bone mineral density and muscle mass by DXA equipment, muscle thickness by ultrasound, peak torque of the knee extensor and flexor muscles by an isokinetic dynamometer, hand grip, balance static postural and vertical jump on a force platform, dynamic balance using the Timed Up and Go test, SPPB battery, fear (FES-I) and incidence of falls and quality of life (SF-36).
- Being tested
- Triplanar vibrating platform, Side-alternating vibrating platform, Sham vibration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triplanar vibrating platformDevice
Mechanical vibration emitted by triplanar vibrating platforms
Side-alternating vibrating platformDevice
Mechanical vibration emitted by side-alternating vibrating platforms
Sham vibrationOther
Simulated vibration
| Study group | Role | What they receive |
|---|---|---|
| Triplanar Vibration (synchronous) | Experimental | Triplanar vibration, performed at 25 Hz and 4 mm peak-to-peak displacement, for 5 minutes each session, three times a week. Participants will be positioned standing, with knees semi-flexed at 30º. Receives: Device: Triplanar vibrating platform |
| Side-alternating vibration | Experimental | Vibration with alternating side of the base, performed at 25 Hz and 4 mm peak-to-peak displacement, for 5 minutes each session, three times a week. Participants will be positioned standing, with knees semi-flexed at 30º. Receives: Device: Side-alternating vibrating platform |
| False vibration | Sham comparator | Platform identical to the other two used by the experimental groups, configured at 25 Hz, however, without peak-to-peak displacement. The platform starts the engine and emits an operating sound identical to a vibrating platform in operation, but does not generate any mechanical vibration. Participants will be positioned standing, with knees semi-flexed at 30º and must remain on the equipment for 5 minutes each session, three times a week. Receives: Other: Sham vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Bone mineral density of the lumbar spine, total hip, femoral neck and trochanter assessed by DXA, expressed in g/cm2
Measured: Baseline (pre-intervention), 6-months and 12-months
Appendicular skeletal muscle mass
Appendicular skeletal muscle mass assessed by DXA, expressed in kg/m2
Measured: Baseline (pre-intervention), 6-months and 12-months
Secondary outcomes (11)
Muscle thickness
Thickness of the rectus femoris muscle assessed by ultrasound, expressed in cm
Measured: Baseline (pre-intervention), 6-months and 12-months
Physical Performance
SPPB functional test battery composed of: static balance (feet together, semi-tandem, and full-tandem); gait speed test (4m); and 5-time sit-to-stand. All expressed in seconds.
Measured: Baseline (pre-intervention), 6-months and 12-months
Dynamic balance
Timed Up and Go test: time taken to get up from a chair, walk three meters, return and sit down in the chair.
Measured: Baseline (pre-intervention), 6-months and 12-months
Hand grip strength
Handgrip test using a Jamar hydraulic dynamometer, expressed in kg.
Measured: Baseline (pre-intervention), 6-months and 12-months
Static postural balance anterior-posterior
Bipedal and semi-tandem postural balance test on a force platform to verify the antero-posterior displacement speed (cm/s).
Measured: Baseline (pre-intervention), 6-months and 12-months
Static postural balance medial-lateral
Bipedal and semi-tandem postural balance test on a force platform to verify the medio-lateral displacement speed (cm/s).
Measured: Baseline (pre-intervention), 6-months and 12-months
Static postural balance - area
Bipedal and semi-tandem postural balance test on a force platform to verify the COP area (cm2).
Measured: Baseline (pre-intervention), 6-months and 12-months
Muscle power
Countermovement vertical jump with hands on waist to identify the power of the lower limbs expressed in watts.
Measured: Baseline (pre-intervention), 6-months and 12-months
Lower limb muscle strength
Peak isokinetic torque (N.m) of the knee extensor and flexor muscles (concentric/concentric) evaluated by an isokinetic dynamometer at angular velocities of 60, 180 and 300º/s.
Measured: Baseline (pre-intervention), 6-months and 12-months
Fear of falls
Fear of falls assessed by the falls efficacy scale-international (FES-I), which generates scores from 16 to 64 points.
Measured: Baseline (pre-intervention), 6-months and 12-months
Health-related quality of life
The SF-36 questionnaire will be used, which generates scores of 0-100 points for eight domains of health-related quality of life.
Measured: Baseline (pre-intervention), 6-months and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start15 Jan 2024
- Primary completion26 Feb 2026
- Study completion26 Feb 2026
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual do Norte do Parana
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Raphael Goncalves de Oliveira, Universidade Estadual do Norte do Parana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222931
- Sponsor's protocol ID
- 0002_UENP
- Status last verified
- May 2026
- First submitted
- 15 Jan 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole Body Vibration in Different Devices on Bone and Muscle Mass, Physical Performance, Quality of Life and Falls in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06222931
- Acronym / sponsor ID
- 0002_UENP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Universidade Estadual do Norte do ParanaUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 25 Jan 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.
Postmenopausal women suffer from a series of negative health factors, such as decreased bone and muscle mass and physical performance, increasing the risk of falls and decreasing quality of life. Therefore, intervention strategies aimed at mitigating these factors are essential. A technique that has been studied and can reverse these factors is whole-body vibration (WBV), however studies present contradictory results and the main confounding factor appears to be related to the type of vibration (synchronous or side-alternating). Therefore, the primary objective of this project is to verify the effects of 12 months of whole-body vibration on different devices on bone mineral density measurements in postmenopausal women. As a secondary objective, the effects on muscle mass, physical performance, quality of life and falls will be verified. 127 postmenopausal women will participate in the study and will be randomized to: triplanar vibration (synchronous); side-alternating vibration; or false vibration. The interventions will last 12 months and will occur three times a week on non-consecutive days. The following assessments will be carried out at baseline, 6-months and 12-months: bone mineral density and muscle mass by DXA equipment, muscle thickness by ultrasound, peak torque of the knee extensor and flexor muscles by an isokinetic dynamometer, hand grip, balance static postural and vertical jump on a force platform, dynamic balance using the Timed Up and Go test, SPPB battery, fear (FES-I) and incidence of falls and quality of life (SF-36).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Triplanar Vibration (synchronous) | Experimental | Device: Triplanar vibrating platformTriplanar vibration, performed at 25 Hz and 4 mm peak-to-peak displacement, for 5 minutes each session, three times a week. Participants will be positioned standing, with knees semi-flexed at 30º. |
| Side-alternating vibration | Experimental | Device: Side-alternating vibrating platformVibration with alternating side of the base, performed at 25 Hz and 4 mm peak-to-peak displacement, for 5 minutes each session, three times a week. Participants will be positioned standing, with knees semi-flexed at 30º. |
| False vibration | Sham comparator | Other: Sham vibrationPlatform identical to the other two used by the experimental groups, configured at 25 Hz, however, without peak-to-peak displacement. The platform starts the engine and emits an operating sound identical to a vibrating platform in operation, but does not generate any mechanical vibration. Participants will be positioned standing, with knees semi-flexed at 30º and must remain on the equipment for 5 minutes each session, three times a week. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Being postmenopausal (without menstruating for at least 12 months);
- Not performing physical exercise systematically for at least 6 months;
- Not needing assistance to carry out daily tasks;
- Do not present serious cognitive problems that make it impossible to understand simple commands;
- Do not have serious dysfunctions or implants in the spine, hips or lower limbs;
Key exclusion criteria (2 listed)
- Withdraw from participating in the study for any reason;
- Present adverse events during interventions that cannot be controlled.
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 |
|---|---|---|
| Triplanar vibrating platformMechanical vibration emitted by triplanar vibrating platforms | Device | Triplanar Vibration (synchronous) |
| Side-alternating vibrating platformMechanical vibration emitted by side-alternating vibrating platforms | Device | Side-alternating vibration |
| Sham vibrationSimulated vibration | Other | False vibration |
Primary outcome
Bone mineral density
Time frame: Baseline (pre-intervention), 6-months and 12-months
Bone mineral density of the lumbar spine, total hip, femoral neck and trochanter assessed by DXA, expressed in g/cm2
Appendicular skeletal muscle mass
Time frame: Baseline (pre-intervention), 6-months and 12-months
Appendicular skeletal muscle mass assessed by DXA, expressed in kg/m2
11 secondary outcomes
Muscle thickness
Time frame: Baseline (pre-intervention), 6-months and 12-months
Physical Performance
Time frame: Baseline (pre-intervention), 6-months and 12-months
Dynamic balance
Time frame: Baseline (pre-intervention), 6-months and 12-months
Hand grip strength
Time frame: Baseline (pre-intervention), 6-months and 12-months
Static postural balance anterior-posterior
Time frame: Baseline (pre-intervention), 6-months and 12-months
Static postural balance medial-lateral
Time frame: Baseline (pre-intervention), 6-months and 12-months
Static postural balance - area
Time frame: Baseline (pre-intervention), 6-months and 12-months
Muscle power
Time frame: Baseline (pre-intervention), 6-months and 12-months
Lower limb muscle strength
Time frame: Baseline (pre-intervention), 6-months and 12-months
Fear of falls
Time frame: Baseline (pre-intervention), 6-months and 12-months
Health-related quality of life
Time frame: Baseline (pre-intervention), 6-months and 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triplanar vibrating platform and Side-alternating vibrating platform in people with Bone Density and Muscles, run by Universidade Estadual do Norte do Parana at 1 site in Brazil.
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 11 inclusion and 2 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: finished, as of the sponsor's last update on 1 Jun 2026. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: Baseline (pre-intervention), 6-months and 12-months). The study lists 2 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 1 Jun 2026.