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

This study has been completed.
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: February 23, 2016
Last verified: February 2016
  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. 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 Intervention
Patients Following Lung Transplantation (Single and Double)
Other: Pulmonary rehabilitation + 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:


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


Enrollment: 140
Study Start Date: January 2012
Study Completion Date: December 2015
Primary Completion Date: December 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
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480960

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

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: February 23, 2016
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 September 26, 2016