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Effects of a Whole Body Vibration Training in Patients After Lung Transplantation

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ClinicalTrials.gov Identifier: NCT01480960
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken

Brief Summary:
Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in patients following lung transplantation. Exercise training has been shown to be a cornerstone of an inpatient rehabilitation program to reduce muscle dysfunction and improve exercise performance. In our study we will investigate the benefit of a whole body vibration training in addition to a standard pulmonary rehabilitation program that includes endurance and strength training. We will include a total of 140 patients (70 patients < 1 year after lung Transplantation and 70 patients > 1 year after lung Transplantation). Our hypothesis is that an addtitional whole body vibration training produces a greater benefit to exercise capacity in lung transplantat patients (LTx).

Condition or disease Intervention/treatment Phase
Patients Following Lung Transplantation (Single and Double) Other: Pulmonary rehabilitation + whole body vibration training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Whole Body Vibration Training on the Exercise Performance in Patients After Lung Transplantation
Study Start Date : January 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Whole body vibration training
Whole body vibration training in addition to pulmonary rehabilitation
Other: Pulmonary rehabilitation + whole body vibration training
standard inpatient rehabilitation program including endurance and strength plus squats on a vibration plate for 4x2 minutes, 3 times per week
Other Name: Galileo training
No Intervention: No whole body vibration training
Pulmonary rehabilitation without whole body vibration training



Primary Outcome Measures :
  1. change in 6-minute walking distance [ Time Frame: change from baseline to day 21 ]

Secondary Outcome Measures :
  1. change in Wmax [ Time Frame: change from baseline to day 21 ]
    maximum workload in incremental cycling test

  2. change in Fmax [ Time Frame: change from baseline to day 21 ]
    maximum isometric quadriceps force

  3. change in fibre cross sectional area [ Time Frame: change from baseline to day 21 ]
    cross sectional area of the M.rectus femoris, measured by ultrasound

  4. change in chair rise time [ Time Frame: change from baseline to day 21 ]
    chair rise test: to get from a sitting position to a standing, measuring the time for 5 repetitions

  5. change in quality of life [ Time Frame: change from baseline to day 21 ]
    SF-36 questionnaire and CRQ questionnaire

  6. change in body cell mass [ Time Frame: change from baseline to day 21 ]
    measured by bio-impedance analysis

  7. change in IGF-1 [ Time Frame: change from baseline to day 21 ]
    IGF-1, measured in a blood sample



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • participation in an inpatient rehabilitation program
  • double or single lung transplantation due to chronic obstructive pulmonary disease, Alpha-1-antitrypsine deficiency, interstitial lung disease

Exclusion Criteria:

  • severe exacerbation in the last 4 weeks with the necessity of delivering antibiotics/ corticosteroids
  • non-compliance

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): NCT01480960


Locations
Germany
Schön Klinik Berchtesgadener Land
Schönau am Königssee, Germany, 83471
Sponsors and Collaborators
Klinikum Berchtesgadener Land der Schön-Kliniken

Responsible Party: Klaus Kenn, Dr. med. Klaus Kenn, Head physician, Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier: NCT01480960     History of Changes
Other Study ID Numbers: LTX2011
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016

Keywords provided by Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken:
lung transplantation
whole body vibration
exercise training
pulmonary rehabilitation