Whole-body Vibration Physiotherapy in Kidney Transplantation

Study Overview
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Brief Summary
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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

Detailed Description
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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. Objective Primary: - To determine the effect of post-transplantation stochastic WBV therapy on preservation of functional muscle strength. Secondary: To assess a) the efficacy of post-transplantation stochastic WBV on body balance b) the efficacy of post-transplantation stochastic WBV on preservation of lean muscle mass determined by Magnetic Resonance Spectroscopy (MRS) c) the changes in bone turnover markers in renal transplant recipients under stochastic WBV therapy d) the short-term safety of stochastic WBV therapy in renal transplant recipients. Methods Prospective, randomized, double-blinded, placebo-controlled setting. Recruited individuals will be randomized in Group 1 (intervention) and in Group 2 (placebo). All participants will be evaluated monthly for occurrence of falls and fractures, and treatment-associated side effects. Testing will be performed upon study entry and at 3 and 6 months according to the following schedule: Visit 1 (Baseline): Muscle strength measurement Neuromuscular tests (SPPBT) Magnetic resonance spectroscopy (MRS) Turnover Markers (blood) Visits 2 and 3 (after 3 and 6 months respectively): Identical to visit 1

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

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Other: Stochastic whole body vibration (WBV) therapy - Physiotherapeutical intervention
* Other: Stochastic whole body vibration (WBV) therapy - Sham physiotherapeutical intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physiotherapeutical intervention<br>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. | Other: Stochastic whole body vibration (WBV) therapy - Physiotherapeutical intervention<br>* Physiotherapeutical intervention<br>|
| Sham Comparator: Sham physiotherapeutical intervention<br>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. | Other: Stochastic whole body vibration (WBV) therapy - Sham physiotherapeutical intervention<br>* Sham physiotherapeutical intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maximal isometric strength of the leg extensors from baseline to 3 and 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney transplantation, Stochastic whole body vibration therapy, Muscle strength, Intramuscular lipid content, Intramyocellular lipid content, Short Physical Performance Battery Test, Prospective, randomised , double blind,placebo-controlled trial, Physical Therapy Modalities