NCT02345577

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 19, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2017

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

2.1 years

First QC Date

January 19, 2015

Last Update Submit

October 24, 2017

Conditions

Kidney Transplantation

Keywords

Kidney transplantationStochastic whole body vibration therapyMuscle strengthIntramuscular lipid contentIntramyocellular lipid contentShort Physical Performance Battery TestProspective, randomised , double blind,placebo-controlled trialPhysical Therapy Modalities

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

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.

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

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.

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

Interventions

Stochastic whole body vibration (WBV) therapy - Physiotherapeutical interventionOTHER

Physiotherapeutical intervention

Physiotherapeutical intervention
Stochastic whole body vibration (WBV) therapy - Sham physiotherapeutical interventionOTHER

Sham physiotherapeutical intervention

Sham physiotherapeutical intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital

Bern, 3010 Bern, Switzerland

Location

Related Publications (5)

  • 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.

    PMID: 21415312BACKGROUND

  • 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.

    PMID: 24348029BACKGROUND

  • 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.

    PMID: 22425243BACKGROUND

  • 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.

    PMID: 22054046BACKGROUND

  • 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.

    PMID: 24828509BACKGROUND

Study Officials

  • Spyridon Arampatzis, MD

    Department of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2015

First Posted

January 26, 2015

Study Start

December 16, 2014

Primary Completion

February 1, 2017

Study Completion

July 17, 2017

Last Updated

October 25, 2017

Record last verified: 2017-10

Locations

CH(1)