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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento Cientรญfico e Tecnolรณgico | OTHER_GOV |
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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. 127 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 30ยบ. |
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| 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 30ยบ. |
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| 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 30ยบ and must remain on the equipment for 5 minutes each session, three times a week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triplanar vibrating platform | Device | Mechanical vibration emitted by triplanar vibrating platforms |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle thickness | Thickness of the rectus femoris muscle assessed by ultrasound, expressed in cm | Baseline (pre-intervention), 6-months and 12-months |
| Physical Performance | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Estadual do Norte do Paranรก | Jacarezinho | Paranรก | 86400-000 | Brazil |
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| Side-alternating vibrating platform | Device | Mechanical vibration emitted by side-alternating vibrating platforms |
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| Sham vibration | Other | Simulated vibration |
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| Baseline (pre-intervention), 6-months and 12-months |
| Dynamic balance | Timed Up and Go test: time taken to get up from a chair, walk three meters, return and sit down in the chair. | Baseline (pre-intervention), 6-months and 12-months |
| Hand grip strength | Handgrip test using a Jamar hydraulic dynamometer, expressed in kg. | Baseline (pre-intervention), 6-months and 12-months |
| Static postural balance anterior-posterior | Bipedal and semi-tandem postural balance test on a force platform to verify the antero-posterior displacement speed (cm/s). | Baseline (pre-intervention), 6-months and 12-months |
| Static postural balance medial-lateral | Bipedal and semi-tandem postural balance test on a force platform to verify the medio-lateral displacement speed (cm/s). | Baseline (pre-intervention), 6-months and 12-months |
| Static postural balance - area | Bipedal and semi-tandem postural balance test on a force platform to verify the COP area (cm2). | Baseline (pre-intervention), 6-months and 12-months |
| Muscle power | Countermovement vertical jump with hands on waist to identify the power of the lower limbs expressed in watts. | Baseline (pre-intervention), 6-months and 12-months |
| Lower limb muscle strength | 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 300ยบ/s. | Baseline (pre-intervention), 6-months and 12-months |
| Fear of falls | Fear of falls assessed by the falls efficacy scale-international (FES-I), which generates scores from 16 to 64 points. | Baseline (pre-intervention), 6-months and 12-months |
| Health-related quality of life | The SF-36 questionnaire will be used, which generates scores of 0-100 points for eight domains of health-related quality of life. | Baseline (pre-intervention), 6-months and 12-months |