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

This study is currently recruiting participants.
Verified April 2012 by Klinikum Berchtesgadener Land der Schön-Kliniken
Sponsor:
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier:
NCT01480960
First received: November 24, 2011
Last updated: April 24, 2012
Last verified: April 2012
History of Changes
  Purpose

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. Our hypothesis is that an addtitional whole body vibration training produces a greater benefit to exercise capacity in lung transplantat patients (LTx).


Condition Intervention
Patients Following Lung Transplantation (Single and Double)
 Other: Pulmonary rehabilitation + whole body vibration training
Other: No whole body vibration training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of a Whole Body Vibration Training on the Exercise Performance in Patients After Lung Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Klinikum Berchtesgadener Land der Schön-Kliniken:

Primary Outcome Measures:
  • change in 6-minute walking distance [ Time Frame: change from baseline to day 21 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • change in Wmax [ Time Frame: change from baseline to day 21 ] [ Designated as safety issue: No ]
    maximum workload in incremental cycling test

  • change in Fmax [ Time Frame: change from baseline to day 21 ] [ Designated as safety issue: No ]
    maximum isometric quadriceps force

  • change in fibre cross sectional area [ Time Frame: change from baseline to day 21 ] [ Designated as safety issue: No ]
    cross sectional area of the M.rectus femoris, measured by ultrasound

  • change in chair rise time [ Time Frame: change from baseline to day 21 ] [ Designated as safety issue: No ]
    chair rise test: to get from a sitting position to a standing, measuring the time for 5 repetitions

  • change in quality of life [ Time Frame: change from baseline to day 21 ] [ Designated as safety issue: No ]
    SF-36 questionnaire and CRQ questionnaire

  • change in body cell mass [ Time Frame: change from baseline to day 21 ] [ Designated as safety issue: No ]
    measured by bio-impedance analysis

  • change in IGF-1 [ Time Frame: change from baseline to day 21 ] [ Designated as safety issue: No ]
    IGF-1, measured in a blood sample


Estimated Enrollment: 140
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Whole body vibration training
Whole body vibration training in addition to pulmonary rehabilitation
 Other: Pulmonary rehabilitation + whole body vibration training
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
 Other: No whole body vibration training
standard inpatient rehabilitation program including endurance and strength training without additional whole body vibration training

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • participation in an inpatient rehabilitation program
  • double or single lung transplantation
  • obstructive lung disease: COPD, Alpha-1-antitrypsine deficiency

Exclusion Criteria:

  • severe exacerbation in the last 4 weeks with the necessity of delivering antibiotics/ corticosteroids
  • non-compliance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480960

Contacts
Contact: Klaus Kenn, Dr. med. 0049865293 ext 1540 kkenn@schoen-kliniken.de

Locations
Germany
Schön Klinik Berchtesgadener Land Recruiting
Schönau am Königssee, Germany, 83471
Sub-Investigator: Inga Heinzelmann, MSc            
Sub-Investigator: Rainer Glöckl, MSc            
Sponsors and Collaborators
Klinikum Berchtesgadener Land der Schön-Kliniken
  More Information

No publications provided

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
Study First Received: November 24, 2011
Last Updated: April 24, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 19, 2013