Bone Density, Muscles, Physical Functional Performance, Accidental Falls, Quality of Life
Conditions
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).
Interventions
DEVICETriplanar vibrating platform
Mechanical vibration emitted by triplanar vibrating platforms
DEVICESide-alternating vibrating platform
Mechanical vibration emitted by side-alternating vibrating platforms
OTHERSham vibration
Simulated vibration
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Universidade Estadual do Norte do Parana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral density | 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 |
| Appendicular skeletal muscle mass | Baseline (pre-intervention), 6-months and 12-months | Appendicular skeletal muscle mass assessed by DXA, expressed in kg/m2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic balance | Baseline (pre-intervention), 6-months and 12-months | Timed Up and Go test: time taken to get up from a chair, walk three meters, return and sit down in the chair. |
| Hand grip strength | Baseline (pre-intervention), 6-months and 12-months | Handgrip test using a Jamar hydraulic dynamometer, expressed in kg. |
| Static postural balance | Baseline (pre-intervention), 6-months and 12-months | 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). |
| Muscle thickness | Baseline (pre-intervention), 6-months and 12-months | Thickness of the rectus femoris muscle assessed by ultrasound, expressed in cm |
| Lower limb muscle strength | Baseline (pre-intervention), 6-months and 12-months | 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. |
| Fear of falls | Baseline (pre-intervention), 6-months and 12-months | Fear of falls assessed by the falls efficacy scale-international (FES-I), which generates scores from 16 to 64 points. |
| Health-related quality of life | Baseline (pre-intervention), 6-months and 12-months | The SF-36 questionnaire will be used, which generates scores of 0-100 points for eight domains of health-related quality of life. |
| Muscle power | Baseline (pre-intervention), 6-months and 12-months | Countermovement vertical jump with hands on waist to identify the power of the lower limbs expressed in watts. |
| Physical Performance | Baseline (pre-intervention), 6-months and 12-months | 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. |
Countries
Brazil
Contacts
Primary ContactRaphael G de Oliveira, PhD
Backup ContactLaís C de Oliveira, PhD
Outcome results
None listed