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

February 23, 2016 updated by: Klaus Kenn, Schön Klinik Berchtesgadener Land

Effects of a Whole Body Vibration Training on the Exercise Performance in Patients After Lung Transplantation

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Schönau am Königssee, Germany, 83471
        • Schön Klinik Berchtesgadener Land

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Galileo training
No Intervention: No whole body vibration training
Pulmonary rehabilitation without whole body vibration training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in 6-minute walking distance
Time Frame: change from baseline to day 21
change from baseline to day 21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Wmax
Time Frame: change from baseline to day 21
maximum workload in incremental cycling test
change from baseline to day 21
change in Fmax
Time Frame: change from baseline to day 21
maximum isometric quadriceps force
change from baseline to day 21
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
change from baseline to day 21
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
change from baseline to day 21
change in quality of life
Time Frame: change from baseline to day 21
SF-36 questionnaire and CRQ questionnaire
change from baseline to day 21
change in body cell mass
Time Frame: change from baseline to day 21
measured by bio-impedance analysis
change from baseline to day 21
change in IGF-1
Time Frame: change from baseline to day 21
IGF-1, measured in a blood sample
change from baseline to day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schön Klinik Berchtesgadener Land

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

November 24, 2011

First Submitted That Met QC Criteria

November 24, 2011

First Posted (Estimate)

November 29, 2011

Study Record Updates

Last Update Posted (Estimate)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LTX2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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