Clinical trial NCT06222931: Effects of Whole Body Vibration in Different Devices on Bone and Muscle Mass in Postmenopausal Women
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Density
Muscles
Physical Functional Performance
Accidental Falls
Quality of Life
Lead sponsor: Universidade Estadual do Norte do Parana
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2024-01-25
Enrollment: 228
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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.

Primary outcomes:
measure: Bone mineral density
timeFrame: Baseline (pre-intervention), 6-months and 12-months
measure: Appendicular skeletal muscle mass
timeFrame: Baseline (pre-intervention), 6-months and 12-months
Secondary outcomes:
measure: Muscle thickness
timeFrame: Baseline (pre-intervention), 6-months and 12-months
measure: Physical Performance
timeFrame: Baseline (pre-intervention), 6-months and 12-months
measure: Dynamic balance
timeFrame: Baseline (pre-intervention), 6-months and 12-months
measure: Hand grip strength
timeFrame: Baseline (pre-intervention), 6-months and 12-months
measure: Static postural balance
timeFrame: Baseline (pre-intervention), 6-months and 12-months
measure: Muscle power
timeFrame: Baseline (pre-intervention), 6-months and 12-months
measure: Lower limb muscle strength
timeFrame: Baseline (pre-intervention), 6-months and 12-months
measure: Fear of falls
timeFrame: Baseline (pre-intervention), 6-months and 12-months
measure: Health-related quality of life
timeFrame: Baseline (pre-intervention), 6-months and 12-months
Other outcomes:
Locations:
city: Jacarezinho
country: Brazil
facility: Universidade Estadual do Norte do Paraná
state: Paraná
Study officials:
References: