Universidade Estadual do Norte do Paraná
Jacarezinho, Paraná, 86400-000, Brazil
NCT Number: NCT06222931
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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Notify Me50 year–80 year
Female
Interventional
Not applicable
Jacarezinho, Paraná, 86400-000, Brazil
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mechanical vibration emitted by triplanar vibrating platforms
Mechanical vibration emitted by side-alternating vibrating platforms
Simulated vibration
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
Time frame: Baseline (pre-intervention), 6-months and 12-months
Appendicular skeletal muscle mass assessed by DXA, expressed in kg/m2
Time frame: Baseline (pre-intervention), 6-months and 12-months
Thickness of the rectus femoris muscle assessed by ultrasound, expressed in cm
Time frame: 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.
Time frame: 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.
Time frame: Baseline (pre-intervention), 6-months and 12-months
Handgrip test using a Jamar hydraulic dynamometer, expressed in kg.
Time frame: 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).
Time frame: Baseline (pre-intervention), 6-months and 12-months
Bipedal and semi-tandem postural balance test on a force platform to verify the medio-lateral displacement speed (cm/s).
Time frame: Baseline (pre-intervention), 6-months and 12-months
Bipedal and semi-tandem postural balance test on a force platform to verify the COP area (cm2).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Universidade Estadual do Norte do Parana
Other
Effects of Whole Body Vibration in Different Devices on Bone and Muscle Mass, Physical Performance, Quality of Life and Falls in Postmenopausal Women
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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