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

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. 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).

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Physical Functional Performance; Bone Density; Accidental Falls; Muscles
• Intervention / Treatment: Device: Triplanar vibrating platform; Device: Side-alternating vibrating platform; Other: Sham vibration

• Study Type: Interventional
• Enrollment (Estimated): 228
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raphael G de Oliveira, PhD; Phone Number: +55(43)99641-7628; Email: rgoliveira@uenp.edu.br
• Study Contact Backup: Name: Laís C de Oliveira, PhD; Phone Number: +55(43)99613-7944; Email: oliveiralc@uenp.edu.br

Study Locations

• Brazil
  • Paraná
    • Jacarezinho, Paraná, Brazil, 86400-000
      • Recruiting
      • Universidade Estadual do Norte do Paraná
      • Contact: Raphael Oliveira, PhD; Phone Number: +55 43 99641-7628; Email: rgoliveira@uenp.edu.br
      • Contact: Laís C de Oliveira, PhD; Phone Number: +55 43 99613-7944; Email: oliveiralc@uenp.edu.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Mechanical vibration emitted by triplanar vibrating platforms
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; Mechanical vibration emitted by side-alternating vibrating platforms
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; Simulated vibration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone mineral density	Bone mineral density of the lumbar spine, total hip, femoral neck and trochanter assessed by DXA, expressed in g/cm2	Baseline (pre-intervention), 6-months and 12-months
Appendicular skeletal muscle mass	Appendicular skeletal muscle mass assessed by DXA, expressed in kg/m2	Baseline (pre-intervention), 6-months and 12-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle thickness	Thickness of the rectus femoris muscle assessed by ultrasound, expressed in cm	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.	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.	Baseline (pre-intervention), 6-months and 12-months
Hand grip strength	Handgrip test using a Jamar hydraulic dynamometer, expressed in kg.	Baseline (pre-intervention), 6-months and 12-months
Static postural balance	Bipedal and semi-tandem postural balance test on a force platform to verify the antero-posterior displacement speed (cm/s), medio-lateral displacement speed (cm/s) and COP area (cm2).	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.	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.	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.	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.	Baseline (pre-intervention), 6-months and 12-months

Collaborators and Investigators

• Sponsor: Universidade Estadual do Norte do Paraná
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: January 15, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 0002_UENP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No