Clinical trial NCT02345577: Whole-body Vibration Physiotherapy in Kidney Transplantation
Official title: Effects of Stochastic Whole-body Vibration Physiotherapy-WBV (Stochastic Resonance Physiotherapy-SRT) on Muscle Strength in Patients After Kidney Transplantation: a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Kidney Transplantation
Keywords: 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
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Bern University of Applied Sciences
First posted: 2015-01-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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

Eligibility criteria: 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)

Primary outcomes:
measure: Change in maximal isometric strength of the leg extensors from baseline to 3 and 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change of neuromuscular test (SPPBT)-score from baseline to 3 and 6 months
timeFrame: 6 months
measure: Change of muscle mass from baseline to 3 and 6 months
timeFrame: 6 months
measure: Change of intramuscular lipid content from baseline to 3 and 6 months
timeFrame: 6 months
measure: Change of intramyocellular (calf) lipid content from baseline to 3 and 6 months
timeFrame: 6 months
measure: Falls during study period
timeFrame: 6 months
measure: Fractures during study period
timeFrame: 6 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital
Study officials:
affiliation: Department of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital
name: Spyridon Arampatzis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Streja E, Molnar MZ, Kovesdy CP, Bunnapradist S, Jing J, Nissenson AR, Mucsi I, Danovitch GM, Kalantar-Zadeh K. Associations of pretransplant weight and muscle mass with mortality in renal transplant recipients. Clin J Am Soc Nephrol. 2011 Jun;6(6):1463-73. doi: 10.2215/CJN.09131010. Epub 2011 Mar 17.
citation: Lai CL, Tseng SY, Chen CN, Liao WC, Wang CH, Lee MC, Hsu PS. Effect of 6 months of whole body vibration on lumbar spine bone density in postmenopausal women: a randomized controlled trial. Clin Interv Aging. 2013;8:1603-9. doi: 10.2147/CIA.S53591. Epub 2013 Dec 4.
citation: Rogan S, Hilfiker R, Schmid S, Radlinger L. Stochastic resonance whole-body vibration training for chair rising performance on untrained elderly: a pilot study. Arch Gerontol Geriatr. 2012 Sep-Oct;55(2):468-73. doi: 10.1016/j.archger.2012.02.011. Epub 2012 Mar 16.
citation: Rogan S, Hilfiker R, Herren K, Radlinger L, de Bruin ED. Effects of whole-body vibration on postural control in elderly: a systematic review and meta-analysis. BMC Geriatr. 2011 Nov 3;11:72. doi: 10.1186/1471-2318-11-72.
citation: Calendo LR, Taeymans J, Rogan S. [Does muscle activation during whole-body vibration induce bone density improvement in postmenopausal women?--A systematic review]. Sportverletz Sportschaden. 2014 Sep;28(3):125-31. doi: 10.1055/s-0034-1366545. Epub 2014 May 14. German.