Effects of Whole Body Vibration in Different Devices on Bone and Muscle Mass, Physical Performance, Quality of Life and Falls in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Appendicular skeletal muscle mass
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Withdraw from participating in the study for any reason;
- •Present adverse events during interventions that cannot be controlled.
研究组 & 干预措施
False 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.
干预措施: Sham vibration (Other)
Triplanar Vibration (synchronous)
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.
干预措施: Triplanar vibrating platform (Device)
Side-alternating vibration
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.
干预措施: Side-alternating vibrating platform (Device)
结局指标
主要结局
Appendicular skeletal muscle mass
时间窗: Baseline (pre-intervention), 6-months and 12-months
Appendicular skeletal muscle mass assessed by DXA, expressed in kg/m2
Bone mineral density
时间窗: 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
次要结局
- 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)
研究者
Raphael Goncalves de Oliveira
Professor
Universidade Estadual do Norte do Parana