Effect of Whole-body Vibration Training on Bone Mineral Density and Physical Performance in Patient With Renal Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- bone mineral density
研究概览
简要总结
To show the effect of whole-body vibration in physical performance in patients with renal dialysis.
详细描述
By now, safety and efficacy of WBV has not been investigated in patients with ESRD. Therefore, we performed this exploratory study in hemodialysis patients in order to elucidate potential effects of whole-body vibration exercise on physical performance and various biochemical markers in this condition. WBV is extensively studied as a means to prevent microgravity and immobility associated muscle wasting and bone loss in space flight and it is getting increasingly popular even among elderly.
Whole-body vibration exercise (WBVE) is a novel exercise protocol designed to prevent the loss of muscle strength and bone mineralization during the immobility and weightlessness of space flight.
A situation similar to HD. Vibration exercise uses high-frequency vibration of muscle groups causing positive feedback of the spinal reflex arc and resulting in high levels of muscle contraction to motor unit recruitment. There can be multiple physiological benefits from vibration exercise, including cardiovascular effects, bone health and muscle strength.
The advantages of WBV result from the combination of hardly any physical stress for the participants, short duration of intervention and a comparatively high effectiveness. means of exercise that can also be offered to those patients unable or unwilling to perform conventional training.
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
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All patients that will be included in this study will meet the following criteria:
- •Body mass index (BMI) from 25.0 to 29.9 kg/m
- •Quitting smoking for more than 3 months.
- •Their age will be ranged from 60-70 years old.
- •Clinically and medically stable.
- •Hemodialysis treatment over at least 6 months before enrollment.
- •Patients with CKD (systolic blood pressure < 140 mmHg diastolic blood pressure < 90 mmHg and heart rate < 80 bpm).
- •The presence of kidney damage (i.e., albuminuria) or decreased kidney function (i.e. glomerular filtration rate (GFR) < 60 ml/min per 1-73 m2) for 3 months or more irrespective of clinical diagnosis.
排除标准
- •Patients will be excluded if they have:
- •Patients with uncontrolled pulmonary disease.
- •Patients with vascular severe complication as critical limb ischemia.
- •Patients with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure.
- •Patients with severe musculoskeletal problems (e.g., severe knee osteoarthritis or post knee replacement surgeries).
- •Any patients who missed more than two weeks of the program or want to terminate the program.
研究组 & 干预措施
whole body vibration group
Thirty male patients will receive whole body vibration twice / week for 12 weeks with duration from 30 to 60secound until reach 20 minutes and intensity begin from initially 5 HZ until reach 28 HZ gradually increase each 4 weeks in addition to medication (Red Blood Cell Stimulating Agents, Iron, Blood Pressure Medications, Phosphate Binders, Vitamins B and C, Calcitriol, Cinacalcet and Antibiotics).
干预措施: whole body vibration (Device)
control group
Thirty male patients will receive their own medication only (Red Blood Cell Stimulating Agents, Iron, Blood Pressure Medications, Phosphate Binders, Vitamins B and C, Calcitriol, Cinacalcet and Antibiotics).
结局指标
主要结局
bone mineral density
时间窗: 3 months
Blood sample to take bone mineral density. (calcium \& phosphorus)
physical performance
时间窗: 3 months
For participant's functional status will be evaluated by a series of physical performance tests
次要结局
未报告次要终点
研究者
Norhan Elsaid Ahmed Elsaid
Principal Investigator
Cairo University