Effects of Whole Body Vibration in Different Devices on Bone and Muscle Mass, Physical Performance, Quality of Life and Falls in Postmenopausal Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bone Density
- Sponsor
- Universidade Estadual do Norte do Parana
- Enrollment
- 228
- Locations
- 1
- Primary Endpoint
- Appendicular skeletal muscle mass
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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).
Investigators
Raphael Goncalves de Oliveira
Professor
Universidade Estadual do Norte do Parana
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;
Exclusion Criteria
- •Withdraw from participating in the study for any reason;
- •Present adverse events during interventions that cannot be controlled.
Outcomes
Primary Outcomes
Appendicular skeletal muscle mass
Time Frame: Baseline (pre-intervention), 6-months and 12-months
Appendicular skeletal muscle mass assessed by DXA, expressed in kg/m2
Bone mineral density
Time Frame: Baseline (pre-intervention), 6-months and 12-months
Bone mineral density of the lumbar spine, total hip, femoral neck and trochanter assessed by DXA, expressed in g/cm2
Secondary Outcomes
- Physical Performance(Baseline (pre-intervention), 6-months and 12-months)
- Muscle thickness(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)
- Muscle power(Baseline (pre-intervention), 6-months and 12-months)
- Lower limb muscle strength(Baseline (pre-intervention), 6-months and 12-months)
- Health-related quality of life(Baseline (pre-intervention), 6-months and 12-months)
- Fear of falls(Baseline (pre-intervention), 6-months and 12-months)