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OpenTrials
Completed

NCT Number: NCT01480960

Effects of a Whole Body Vibration Training 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schön Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmonary rehabilitation + whole body vibration training

Other

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

Primary outcomes

  1. change in 6-minute walking distance

    Time frame: change from baseline to day 21

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 29, 2011
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.