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
  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:


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
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: 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 July 20, 2014