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临床试验/NCT01499186
NCT01499186已完成不适用

The Effect of 6 Months of Local Vibration Training of the Thigh and Hip on Muscle Strength, Muscle Mass, Bone Density, Bone Structure and Functionality in Institutionalized Elderly.

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Bone mineral density hip (change in bone mineral density hip)

研究概览

简要总结

This randomized controlled intervention study in institutionalized elderly investigates the effect of 6 months of local vibration therapy applied on the thigh and hip on muscle strength, muscle mass, bone density, and functionality.

详细描述

As the world population ages, osteoporosis (skeletal fragility) and sarcopenia (decline in muscle mass and muscle strength) are becoming increasingly important public health concerns. Both osteoporosis and sarcopenia contribute to an increased fall risk and an increased number of hip and vertebral fractures. Clearly, the clinical and economic consequences of osteoporosis and sarcopenia, and the resulting falls and fractures, call for major efforts to search for efficient and feasible interventions to prevent or reverse bone and muscle loss. The present project is intended to partly meet this need.

Whole Body Vibration (WBV) training might be an efficient training method. During WBV the subject stands on a platform that generates vertical sinusoidal vibrations. These mechanical stimuli are transmitted to the body where they stimulate the bone and reflexive muscle contractions will be generated. In previous studies performed by the same group, the investigators found that WBV training (frequency 30-40Hz, peak acceleration 3-10g) can be seen as an efficient alternative for strength training, both in the young sedentary as well as in the elderly population. Additionally, the investigators were able to show that 6 months vibration training in elderly females resulted in a net benefit of about 1.5% in bone mineral density of the hip compared with controls. Finally, the investigators have recently shown that long-term vibration training results in an increase of quadriceps muscle mass.

From the above it appears that vibration therapy could be a plausible candidate as an efficient combination therapy for elderly subjects at risk for osteoporosis and sarcopenia and, by implication, the therapy might help to reduce the number of falls and fractures. However, many questions regarding vibration as a therapy still need to be answered in order to optimize both the efficacy and safety of its application. The application methods of vibration therapy should be optimized to be applicable in a broader range of subjects as well as to deliver the stimuli more targeted to specific regions of interest. Whole body vibration in its present form (subjects standing on a vibrating platform) is inadequate for a large part of the elderly population (e.g., subjects with osteoarthritis at the knee, wheelchair bound subjects, bedridden subjects). Additionally, the transmission of the vibration stimulus from the feet to the hip during WBV is probably insufficient to provoke optimal adaptations at this level. Delivering the vibration stimuli locally (i.e. more targeted) at those regions at risk for fractures or in need for muscle strengthening might be an efficient alternative application method.

The main aim of this pilot research is to obtain data that should allow the investigators to optimize the efficacy and safety of the vibration excitation pattern as well as to optimize the application method. With the ageing of the world population and the predicted rise in fall and fracture rates, appropriate strategies to combat muscle and bone loss will have far reaching implications in containing future health care expenditure for the elderly and in reducing the need for institutionalized care.

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 (Investigator)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Above 65 years of age;
  • •Institutionalized in a nursing home, service flat or cloistered community;
  • •Not on bone-active agents;
  • •Approval for participation in the study after a medical screening by a doctor. The general practitioner will also be contacted for approving the participation of the patient;
  • •Signed informed consent.

排除标准

  • •Musculoskeletal disease;
  • •Terminal illness, recent myocardial infarction or unstable cardiovascular conditions;
  • •Participation in resistance training during the past 24 months;
  • •Metallic implants (e.g. prothesis);

研究组 & 干预措施

Control group

No Intervention

There will be no participation in a training program. The control group will perform all measurements.

Intervention group

Experimental

The subjects of the vibration group will be subjected to local vibration training by the use of custom-made cylindrical vibrators. These subjects will perform all measurements.

干预措施: Local Vibration (Other)

结局指标

主要结局

Bone mineral density hip (change in bone mineral density hip)

时间窗: baseline and after 6 months

Bone mineral density of the total hip will be determined by dual - energy x - ray absorptiometry (Hologic, Waltham, MA, USA).

次要结局

  • Functionality (change in functionality)(baseline and 6 months)
  • Physical performance (change in physical performance)(baseline and 6 months)
  • Muscle mass (change in muscle mass)(baseline and 6 months)
  • Muscle strength and muscle power (change in muscle strength and power)(baseline and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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