ClinicalTrials.gov
ClinicalTrials.gov Menu

Whole-body Vibration Physiotherapy in Kidney Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02345577
Recruitment Status : Terminated (Due to low recruitment rate)
First Posted : January 26, 2015
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
Bern University of Applied Sciences
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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


Condition or disease Intervention/treatment Phase
Kidney Transplantation Other: Stochastic whole body vibration (WBV) therapy - Physiotherapeutical intervention Other: Stochastic whole body vibration (WBV) therapy - Sham physiotherapeutical intervention Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : December 16, 2014
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : July 17, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in maximal isometric strength of the leg extensors from baseline to 3 and 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change of neuromuscular test (SPPBT)-score from baseline to 3 and 6 months [ Time Frame: 6 months ]
  2. Change of muscle mass from baseline to 3 and 6 months [ Time Frame: 6 months ]
  3. Change of intramuscular lipid content from baseline to 3 and 6 months [ Time Frame: 6 months ]
  4. Change of intramyocellular (calf) lipid content from baseline to 3 and 6 months [ Time Frame: 6 months ]
  5. Falls during study period [ Time Frame: 6 months ]
  6. Fractures during study period [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345577


Locations
Switzerland
Department of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital
Bern, Switzerland, 3010 Bern
Sponsors and Collaborators
University Hospital Inselspital, Berne
Bern University of Applied Sciences
Investigators
Principal Investigator: Spyridon Arampatzis, MD Department of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital

Publications:
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02345577     History of Changes
Other Study ID Numbers: 176/14
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017

Keywords provided by University Hospital Inselspital, Berne:
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