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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06222931
• Other study ID #: 0002_UENP
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: Universidade Estadual do Norte do Parana
• Contact: Raphael G de Oliveira, PhD
• Phone: +55(43)99641-7628
• Email: rgoliveira[@]uenp.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Triplanar vibrating platform
Mechanical vibration emitted by triplanar vibrating platforms
• Side-alternating vibrating platform
Mechanical vibration emitted by side-alternating vibrating platforms

Other:
• Sham vibration
Simulated vibration

Locations

Country	Name	City	State
Brazil	Universidade Estadual do Norte do Paraná	Jacarezinho	Paraná

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Estadual do Norte do Parana	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Appendicular skeletal muscle mass	Appendicular skeletal muscle mass assessed by DXA, expressed in kg/m2	Baseline (pre-intervention), 6-months and 12-months
Secondary	Muscle thickness	Thickness of the rectus femoris muscle assessed by ultrasound, expressed in cm	Baseline (pre-intervention), 6-months and 12-months
Secondary	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
Secondary	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
Secondary	Hand grip strength	Handgrip test using a Jamar hydraulic dynamometer, expressed in kg.	Baseline (pre-intervention), 6-months and 12-months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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