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

NCT ID: NCT06222931

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2025-06-30

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Triplanar vibrating platform

Intervention Type: DEVICE

Mechanical vibration emitted by triplanar vibrating platforms

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.

Group Type: EXPERIMENTAL

Side-alternating vibrating platform

Intervention Type: DEVICE

Mechanical vibration emitted by side-alternating vibrating platforms

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.

Group Type: SHAM_COMPARATOR

Sham vibration

Intervention Type: OTHER

Simulated vibration

Interventions

Triplanar vibrating platform

Mechanical vibration emitted by triplanar vibrating platforms

Intervention Type: DEVICE

Side-alternating vibrating platform

Mechanical vibration emitted by side-alternating vibrating platforms

Intervention Type: DEVICE

Sham vibration

Simulated vibration

Intervention Type: OTHER

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;
• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Universidade Estadual do Norte do Parana

OTHER

Sponsor Role: lead

Responsible Party

Raphael Goncalves de Oliveira

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Estadual do Norte do Paraná

Jacarezinho, Paraná, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Raphael G de Oliveira, PhD

Role: CONTACT

rgoliveira@uenp.edu.br

+55(43)99641-7628

Laís C de Oliveira, PhD

Role: CONTACT

oliveiralc@uenp.edu.br

+55(43)99613-7944

Facility Contacts

Raphael Oliveira, PhD

Role: primary

rgoliveira@uenp.edu.br

+55 43 99641-7628

Laís C de Oliveira, PhD

Role: backup

oliveiralc@uenp.edu.br

+55 43 99613-7944

Other Identifiers

0002_UENP

Identifier Type: -

Identifier Source: org_study_id