Whole-body Vibration Physiotherapy in Kidney Transplantation

October 24, 2017 updated by: University Hospital Inselspital, Berne

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010 Bern
        • Department of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Physiotherapeutical intervention
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
Physiotherapeutical intervention
Sham Comparator: Sham physiotherapeutical intervention
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
Sham physiotherapeutical intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

Bern University of Applied Sciences

Investigators

  • Principal Investigator: Spyridon Arampatzis, MD, Department of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2014

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

July 17, 2017

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

January 23, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

October 25, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 176/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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