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临床试验/NCT02345577
NCT02345577终止不适用

Effects of Stochastic Whole-body Vibration Physiotherapy-WBV (Stochastic Resonance Physiotherapy-SRT) on Muscle Strength in Patients After Kidney Transplantation: a Pilot Study

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年12月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
10
试验地点
2
主要终点
Change in maximal isometric strength of the leg extensors from baseline to 3 and 6 months

研究概览

简要总结

Kidney recipients loose significant amounts of muscle mass and skeleton minerals in the early post-transplantation period and suffer from increasing abnormalities of neuromuscular functions.

Stochastic whole body vibration (WBV) therapy is a relatively new form of movement physiotherapy that is used for strength training. Various clinical studies have shown that in addition to muscle function, WBV also improved body balance and bone mineral density. To study the impact of stochastic WBV physiotherapy on musculoskeletal parameters after renal transplantation, kidney transplant recipients will be enrolled and undergo WBV. The investigators hypothesize that WBV physiotherapy improves both maximum muscle strength and muscular performance

详细描述

Background

The increasing incidence of muscular wasting, bone disease, falls and related fractures are the price for excellent survival rates in transplanted patients. Kidney recipients loose significant amounts of muscle mass and skeleton minerals in the early post-transplantation period and suffer from increasing abnormalities of neuromuscular functions.

Recently, stochastic whole-body vibration (WBV) has received much attention as a potential muscle-anabolic and anti-osteoporotic intervention. It is suggested that the randomized low-frequency signals produced during such training can activate otherwise high threshold afferent and efferent motor-neurons and thus may result in a considerable neuromuscular activation. Additionally, there data supporting peripherally-induced central biochemical activation, that meaning the production of CNS modulators due to application of mechanical exercise such as stochastic WBV. The result is a rapid (within minutes), transient force increase. Due to the high number of stimuli-repetitions, it is possible to increase muscle strength using shorter training times (<5 min) than with conventional physiotherapeutic methods (> 30 min). Several experimental and clinical studies have shown that in addition to muscle function, WBV also improved body balance and bone mineral density.

Moreover, a population of renal transplant recipients has not yet been studied elsewhere.

WBV is a very appealing approach, foremost in subjects with limited physical activity; it represents a potentially simple and efficient training method for skeletal muscle and better functional performance, thus preventing falls and consequently fractures.

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years old
  • Kidney transplantation in the last 12 months
  • Stable kidney function (eGFR>20 ml/min)
  • No episode of acute rejection during the last 2 months
  • Written informed consent
  • Exclusion Criteria
  • Inability to posture or to perform whole-body vibration therapy or MRS after transplantation
  • Treatment with anabolic medication, fluorine, bisphosphonates, or hormone replacement therapy (estrogens, selective modulators of the estrogenic receptors) within the previous 3 months
  • Treatment with high-dose steroid therapy due to acute rejection episode during the last 2 months before study inclusion
  • Implanted devices (pacemakers, defibrillators, stents, etc.)
  • Pregnancy
  • Previous ophthalmic cataract surgery
  • Previous history of epilepsy
  • Previous recent spine of leg fracture (last 3 months)
  • Other individuals especially in need of protection (according to the Swiss Academy of Medical Sciences)

排除标准

  • 未提供

研究组 & 干预措施

Physiotherapeutical intervention

Active Comparator

3 WBV-sessions per week for 3 consecutive months. Each session consists of 5 series with a duration of 60 sec with 60 sec rest-time with vibration of increasing frequency starting at 1Hz / Noise 4 going up to 6Hz / Noise 5 depending on patients' tolerability and with a fixed 3mm amplitude.

干预措施: Stochastic whole body vibration (WBV) therapy - Physiotherapeutical intervention (Other)

Sham physiotherapeutical intervention

Sham Comparator

3 WBV-sessions per week for 3 consecutive months. Each session consists of 5 series with a duration of 60 sec with 60 sec rest-time at 1 Hz / Noise 1 and 3mm amplitude.

干预措施: Stochastic whole body vibration (WBV) therapy - Sham physiotherapeutical intervention (Other)

结局指标

主要结局

Change in maximal isometric strength of the leg extensors from baseline to 3 and 6 months

时间窗: 6 months

次要结局

  • Change of neuromuscular test (SPPBT)-score from baseline to 3 and 6 months(6 months)
  • Change of muscle mass from baseline to 3 and 6 months(6 months)
  • Change of intramuscular lipid content from baseline to 3 and 6 months(6 months)
  • Change of intramyocellular (calf) lipid content from baseline to 3 and 6 months(6 months)
  • Falls during study period(6 months)
  • Fractures during study period(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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