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Clinical Trials/NCT06222931
NCT06222931
Recruiting
Not Applicable

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

Universidade Estadual do Norte do Parana1 site in 1 country228 target enrollmentJanuary 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bone Density
Sponsor
Universidade Estadual do Norte do Parana
Enrollment
228
Locations
1
Primary Endpoint
Appendicular skeletal muscle mass
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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. 228 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).

Registry
clinicaltrials.gov
Start Date
January 15, 2024
End Date
June 30, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Raphael Goncalves de Oliveira

Professor

Universidade Estadual do Norte do Parana

Eligibility Criteria

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;

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Physical Performance(Baseline (pre-intervention), 6-months and 12-months)
  • Muscle thickness(Baseline (pre-intervention), 6-months and 12-months)
  • Dynamic balance(Baseline (pre-intervention), 6-months and 12-months)
  • Hand grip strength(Baseline (pre-intervention), 6-months and 12-months)
  • Static postural balance(Baseline (pre-intervention), 6-months and 12-months)
  • Muscle power(Baseline (pre-intervention), 6-months and 12-months)
  • Lower limb muscle strength(Baseline (pre-intervention), 6-months and 12-months)
  • Health-related quality of life(Baseline (pre-intervention), 6-months and 12-months)
  • Fear of falls(Baseline (pre-intervention), 6-months and 12-months)

Study Sites (1)

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