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

Last updated: January 15, 2024
Sponsor: Universidade Estadual do Norte do Parana
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bone Density

Treatment

Triplanar vibrating platform

Side-alternating vibrating platform

Sham vibration

Clinical Study ID

NCT06222931
0002_UENP
  • Ages 50-80
  • Female
  • Accepts Healthy Volunteers

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. 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).

Eligibility Criteria

Inclusion

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 simplecommands;
  • 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 orseizures;
  • 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 6months;
  • Have not undergone cancer treatment in the last 5 years.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 228
Treatment Group(s): 3
Primary Treatment: Triplanar vibrating platform
Phase:
Study Start date:
January 15, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Universidade Estadual do Norte do Paraná

    Jacarezinho, Paraná 86400-000
    Brazil

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.