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Completed

NCT Number: NCT06222931

Effects of Whole Body Vibration in Different Devices on Bone and Muscle Mass 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).

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Key information

Age range

50 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Estadual do Norte do Paraná

Jacarezinho, Paraná, 86400-000, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Triplanar vibrating platform

Device

Mechanical vibration emitted by triplanar vibrating platforms

Side-alternating vibrating platform

Device

Mechanical vibration emitted by side-alternating vibrating platforms

Sham vibration

Other

Simulated vibration

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Muscle thickness

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

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

  2. Physical Performance

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

    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.

  3. Dynamic balance

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

    Timed Up and Go test: time taken to get up from a chair, walk three meters, return and sit down in the chair.

  4. Hand grip strength

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

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

  5. Static postural balance anterior-posterior

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

    Bipedal and semi-tandem postural balance test on a force platform to verify the antero-posterior displacement speed (cm/s).

  6. Static postural balance medial-lateral

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

    Bipedal and semi-tandem postural balance test on a force platform to verify the medio-lateral displacement speed (cm/s).

  7. Static postural balance - area

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

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

  8. Muscle power

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

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

  9. Lower limb muscle strength

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

    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.

  10. Fear of falls

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

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

  11. Health-related quality of life

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

    The SF-36 questionnaire will be used, which generates scores of 0-100 points for eight domains of health-related quality of life.

Sponsors and collaborators

Lead sponsor

Universidade Estadual do Norte do Parana

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

Effects of Whole Body Vibration in Different Devices on Bone and Muscle Mass, Physical Performance, Quality of Life and Falls in Postmenopausal Women

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 25, 2024
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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