Effects of Whole Body Vibration in Different Devices on Bone and Muscle Mass in Postmenopausal Women
- Conditions
- MusclesAccidental FallsBone DensityPhysical Functional PerformanceQuality of Life
- Interventions
- Device: Triplanar vibrating platformOther: Sham vibrationDevice: Side-alternating vibrating platform
- Registration Number
- NCT06222931
- Lead Sponsor
- Universidade Estadual do Norte do Parana
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 228
- 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.
- Withdraw from participating in the study for any reason;
- Present adverse events during interventions that cannot be controlled.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Triplanar Vibration (synchronous) Triplanar vibrating platform 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 30º. False vibration Sham vibration 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 30º and must remain on the equipment for 5 minutes each session, three times a week. Side-alternating vibration Side-alternating vibrating platform 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 30º.
- Primary Outcome Measures
Name Time Method Appendicular skeletal muscle mass Baseline (pre-intervention), 6-months and 12-months Appendicular skeletal muscle mass assessed by DXA, expressed in kg/m2
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
- Secondary Outcome Measures
Name Time Method 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.
Muscle thickness Baseline (pre-intervention), 6-months and 12-months Thickness of the rectus femoris muscle assessed by ultrasound, expressed in cm
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 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.
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.
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.
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.
Trial Locations
- Locations (1)
Universidade Estadual do Norte do Paraná
🇧🇷Jacarezinho, Paraná, Brazil