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Vibration Training in Chronic Obstructive Pulmonary Disease (COPD)-Patients During a Three-week Rehabilitation

This study has been completed.
Sponsor:
Information provided by:
Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier:
NCT01380652
First received: April 1, 2011
Last updated: June 24, 2011
Last verified: June 2011
History of Changes
  Purpose

The aim of this study is to investigate the change of physical activity in COPD-patients performing a whole body vibration training additional to a standard three-week rehabilitation program in comparison to patients performing merely a standard rehabilitation program.


Condition Intervention
Chronic Obstructive Pulmonary Disease
 Procedure: pulmonary rehabilitation
Procedure: 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 Whole Body Vibration Training on Physical Activity in Chronic Obstructive Pulmonary Disease (COPD) III/IV-Patients During a Three-week Rehabilitation

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Activity [ Time Frame: day 2 and 17 ] [ Designated as safety issue: Yes ]
    change in activity from baseline to day 17


Secondary Outcome Measures:
  • Diffusion Capacity [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • BODE-Score [ Time Frame: day 1 and 19 ] [ Designated as safety issue: No ]
    Changes in Bode-Score from baseline to day 19

  • lung function [ Time Frame: day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2010
Study Completion Date: May 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rehabilitation with vibration training Procedure: vibration training
pulmonary rehabilitation with strength and endurance training and additionally vibration training
Other Names:
  • whole body vibration
  • Galileo
No Intervention: pulmonary rehabilitation Procedure: pulmonary rehabilitation
pulmonary rehabilitation with strength and endurance training
Other Name: multimodal rehabilitation

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic obstructive pulmonary disease III/IV

Exclusion Criteria:

  • Severe exacerbations in the last 4 weeks prior to begin of study (definition of exacerbation: symptoms on more than 3 days with a relevant change in drug therapy (cortisone, antibiotics))
  • Severe disease other than COPD, that could influence the results of the study
  • Abuse of alcohol or drugs
  • Simultaneously participation in another study
  • Tachypnea (>30/min)
  • Severe exacerbation during rehabilitation
  • Cardiac insufficiency (NYHA IV)
  • Myocardial infarction during the last 6 weeks
  • Mental-health problem
  • Pregnancy
  • Known HIV-infection
  • Slipped disk
  • Acute discopathy
  • Acute thrombosis
  • Implants in trained regions of the body (lower extremities)
  • Acute inflammation of the locomotor system, active arthrosis or rheumatoid arthritis
  • Acute tendinopathy in trained regions of the body
  • Acute hernia
  • Fresh fractures, wounds or scars in trained regions of the body
  • Gallstones or stones in the urinary tract collection system
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01380652

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

No publications provided

Responsible Party: Dr. Klaus Kenn, head physician of pneumology, Schön Klinik Berchtesgadener Land
ClinicalTrials.gov Identifier: NCT01380652     History of Changes
Other Study ID Numbers: BGL-Ga-SW-0810
Study First Received: April 1, 2011
Last Updated: June 24, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Klinikum Berchtesgadener Land der Schön-Kliniken:
COPD III/IV
Activity Monitoring
SenseWear
 Vibration training
Galileo
Pulmonary rehabilitation

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013