Blood Flow and Bone Density in Healthy Adult Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Bone Density of Proximal Femur
研究概览
简要总结
This project will test the efficacy of using a non-invasive neuromuscular stimulation on the plantar surface of the feet to prevent and/ or reverse bone loss in a sample of healthy adult women.
详细描述
Women between the ages of 30 and 60 years of age who work in positions that require them to be seated at desks for a large portion of each day, are capable of following the protocol for one year, have a t-score >- 2.5 (do not have osteoporosis), and respond to plantar stimulation will be asked to participate. Women will be excluded who are receiving medications for osteoporosis, taking hormone replacement therapy, taking steroids (either oral or inhaled), have metal implants in the tibia, hip and spine that interfere with DEXA (bone density) scanning, are professional or semi-professional athletes, have hyperparathyroidism, have a history of pulmonary embolism, deep vein thrombosis, peripheral vascular disease or varicose veins, have a Body Mass Index greater than 40 Kg/m2, have any type of neuromuscular disease, or are pregnant . Once the inclusion and exclusion criteria are met, 45 subjects will be randomized into 3 groups including 1) a group of 15 subjects who will use the device (stimulation) for up to 4 hours a day, 2) a group of 15 subjects that will use the device for up to 8 hours a day, and 3) a control group who will not use the device. Subjects in the two treatment groups will be asked to place their feet on a mechanical device that will deliver a slight vibration while they are seated at work. Vibrations between 30-60 Hz has been shown to stimulate the Meissner's corpuscles which in turn stimulate contraction of the deep muscles of the calves. This contraction has been shown to increase venous and lymphatic return from the lower extremities thus improve bone metabolism. Bone density readings and venous circulation will be measured at the onset of this research and will be repeated after 12 months of using the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy women 30 - 60 years old
- •work in seated positions
排除标准
- •weigh more than 350 pounds
- •pregnant or plan to become pregnant
- •professional athlete
- •currently on Hormone Replacement Therapy
- •currently taking medication for osteoporosis
- •currently on corticosteroids
- •metal implants in tibia hip spine forearm
- •diagnosed with hyperparathyroidism
- •diagnosed with neuromuscular disease
- •pulmonary embolism
- •deep vein thrombosis
- •peripheral vascular disease
- •medications for hypertension
结局指标
主要结局
Bone Density of Proximal Femur
时间窗: One year
Proximal femur bone mineral density by dual energy x-ray absorptiometry (DXA)
次要结局
- Proximal Tibia Bone Density(One year)
研究者
Kenneth McLeod
Professor, BioEngineering
Binghamton University
