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

NCT06222931 | Unknown

• 1 other identifier: 0002_UENP
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Muscle thickness

  Baseline (pre-intervention), 6-months and 12-months

• Physical Performance

  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

Study Arms (3)

Triplanar Vibration (synchronous)

EXPERIMENTAL

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

Side-alternating vibration

EXPERIMENTAL

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

False vibration

SHAM COMPARATOR

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

Interventions

Triplanar vibrating platform DEVICE

Mechanical vibration emitted by triplanar vibrating platforms

Triplanar Vibration (synchronous)

Side-alternating vibrating platform DEVICE

Mechanical vibration emitted by side-alternating vibrating platforms

Side-alternating vibration

Sham vibration OTHER

Simulated vibration

False vibration

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Estadual do Norte do Parana: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Universidade Estadual do Norte do Paraná

Jacarezinho, Paraná, 86400-000, Brazil

RECRUITING

Central Study Contacts

Raphael G de Oliveira, PhD

CONTACT

+55(43)99641-7628; rgoliveira@uenp.edu.br

Laís C de Oliveira, PhD

CONTACT

+55(43)99613-7944; oliveiralc@uenp.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 25, 2024
• Study Start: January 15, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

BR (1)