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

Tracking Information
First Received Date ^ICMJE	April 1, 2011
Last Updated Date	June 24, 2011
Start Date ^ICMJE	September 2010
Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2011)	Activity [ Time Frame: day 2 and 17 ] [ Designated as safety issue: Yes ] change in activity from baseline to day 17
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01380652 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Vibration Training in Chronic Obstructive Pulmonary Disease (COPD)-Patients During a Three-week Rehabilitation
Official Title ^ICMJE	Effects of Whole Body Vibration Training on Physical Activity in Chronic Obstructive Pulmonary Disease (COPD) III/IV-Patients During a Three-week Rehabilitation
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Chronic Obstructive Pulmonary Disease
Intervention ^ICMJE	Procedure: pulmonary rehabilitation pulmonary rehabilitation with strength and endurance training Other Name: multimodal rehabilitation Procedure: vibration training pulmonary rehabilitation with strength and endurance training and additionally vibration training Other Names: whole body vibration Galileo
Study Arm (s)	Experimental: rehabilitation with vibration training Intervention: Procedure: vibration training No Intervention: pulmonary rehabilitation Intervention: Procedure: pulmonary rehabilitation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	40
Completion Date	May 2011
Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01380652
Other Study ID Numbers ^ICMJE	BGL-Ga-SW-0810
Has Data Monitoring Committee	No
Responsible Party	Dr. Klaus Kenn, head physician of pneumology, Schön Klinik Berchtesgadener Land
Study Sponsor ^ICMJE	Klinikum Berchtesgadener Land der Schön-Kliniken
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Klinikum Berchtesgadener Land der Schön-Kliniken
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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