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CompletedNCT06222931Updated Jun 1, 2026

Effects of Whole Body Vibration in Different Devices on Bone and Muscle Mass in Postmenopausal Women

An interventional study of Triplanar vibrating platform and Side-alternating vibrating platform in Bone Density, Muscles and Physical Functional Performance, sponsored by Universidade Estadual do Norte do Parana. Completed at 1 site in Brazil. Open to female participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by Universidade Estadual do Norte do Parana · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
127
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
Female
01

Study 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. 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).

02

Conditions studied

  • Bone Density
  • Muscles
  • Physical Functional Performance
  • Accidental Falls
  • Quality of Life
03

In context

Lead sponsor

Universidade Estadual do Norte do Parana is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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;
  • 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.

Exclusion criteria

Exclusion Criteria:

  • Withdraw from participating in the study for any reason;
  • Present adverse events during interventions that cannot be controlled.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
127 participants (actual)

Study arms

  • Experimental
    Triplanar Vibration (synchronous)

    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.

    Device: Triplanar vibrating platform

  • Experimental
    Side-alternating vibration

    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.

    Device: Side-alternating vibrating platform

  • Sham comparator
    False vibration

    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.

    Other: Sham vibration

Interventions

  • DeviceTriplanar vibrating platform

    Mechanical vibration emitted by triplanar vibrating platforms

  • DeviceSide-alternating vibrating platform

    Mechanical vibration emitted by side-alternating vibrating platforms

  • OtherSham vibration

    Simulated vibration

06

What researchers measure

Primary outcomes

  1. Bone mineral density

    Bone mineral density of the lumbar spine, total hip, femoral neck and trochanter assessed by DXA, expressed in g/cm2

    Time frame: Baseline (pre-intervention), 6-months and 12-months

  2. Appendicular skeletal muscle mass

    Appendicular skeletal muscle mass assessed by DXA, expressed in kg/m2

    Time frame: Baseline (pre-intervention), 6-months and 12-months

Secondary outcomes

  1. Muscle thickness

    Thickness of the rectus femoris muscle assessed by ultrasound, expressed in cm

    Time frame: Baseline (pre-intervention), 6-months and 12-months

  2. 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.

    Time frame: Baseline (pre-intervention), 6-months and 12-months

  3. 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.

    Time frame: Baseline (pre-intervention), 6-months and 12-months

  4. Hand grip strength

    Handgrip test using a Jamar hydraulic dynamometer, expressed in kg.

    Time frame: Baseline (pre-intervention), 6-months and 12-months

  5. 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).

    Time frame: Baseline (pre-intervention), 6-months and 12-months

  6. 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).

    Time frame: Baseline (pre-intervention), 6-months and 12-months

  7. Static postural balance - area

    Bipedal and semi-tandem postural balance test on a force platform to verify the COP area (cm2).

    Time frame: Baseline (pre-intervention), 6-months and 12-months

  8. Muscle power

    Countermovement vertical jump with hands on waist to identify the power of the lower limbs expressed in watts.

    Time frame: Baseline (pre-intervention), 6-months and 12-months

  9. 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.

    Time frame: Baseline (pre-intervention), 6-months and 12-months

  10. Fear of falls

    Fear of falls assessed by the falls efficacy scale-international (FES-I), which generates scores from 16 to 64 points.

    Time frame: Baseline (pre-intervention), 6-months and 12-months

  11. 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.

    Time frame: Baseline (pre-intervention), 6-months and 12-months

07

Study locations

1 site
  • Universidade Estadual do Norte do Paraná
    Jacarezinho, Paraná 86400-000, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06222931
Lead sponsor
Universidade Estadual do Norte do Parana
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Responsible party
Raphael Goncalves de Oliveira (Professor, Universidade Estadual do Norte do Parana) — Principal investigator
First posted
Jan 25, 2024
Start date
Jan 15, 2024
Primary completion
Feb 26, 2026
Completion
Feb 26, 2026
Last update
Jun 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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