Back to resultsVibration Training in Chronic Obstructive Pulmonary Disease (COPD)-Patients During a Three-week Rehabilitation
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
whole body vibration training
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD III/IV, Activity Monitoring, SenseWear, Vibration training, Galileo, Pulmonary rehabilitation
Eligibility 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
Sites / Locations
- Klinikum Berchtesgadener Land, Schön Kliniken
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
rehabilitation with vibration training
rehabilitation without vibration training
Arm Description
Outcomes
Primary Outcome Measures
Activity
change in activity from baseline to day 17
Secondary Outcome Measures
Diffusion Capacity
BODE-Score
Changes in Bode-Score from baseline to day 19
lung function
Full Information
NCT ID
NCT01380652
First Posted
April 1, 2011
Last Updated
March 5, 2015
Sponsor
Schön Klinik Berchtesgadener Land
1. Study Identification
Unique Protocol Identification Number
NCT01380652
Brief Title
Vibration Training in Chronic Obstructive Pulmonary Disease (COPD)-Patients During a Three-week Rehabilitation
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD III/IV, Activity Monitoring, SenseWear, Vibration training, Galileo, Pulmonary rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rehabilitation with vibration training
Arm Type
Experimental
Arm Title
rehabilitation without vibration training
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
whole body vibration training
Other Intervention Name(s)
whole body vibration, Galileo
Intervention Description
pulmonary rehabilitation with strength and endurance training and additionally vibration training
Primary Outcome Measure Information:
Title
Activity
Description
change in activity from baseline to day 17
Time Frame
day 2 and 17
Secondary Outcome Measure Information:
Title
Diffusion Capacity
Time Frame
day 1
Title
BODE-Score
Description
Changes in Bode-Score from baseline to day 19
Time Frame
day 1 and 19
Title
lung function
Time Frame
day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Klinikum Berchtesgadener Land, Schön Kliniken
City
Schönau am Königssee
ZIP/Postal Code
83471
Country
Germany
12. IPD Sharing Statement
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Vibration Training in Chronic Obstructive Pulmonary Disease (COPD)-Patients During a Three-week Rehabilitation
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