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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Procedure: whole body vibration training


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rehabilitation with vibration training<br> | Procedure: whole body vibration training<br>* pulmonary rehabilitation with strength and endurance training and additionally vibration training<br>* Other names: Galileo;|
| No Intervention: rehabilitation without vibration training<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity | change in activity from baseline to day 17 | day 2 and 17 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diffusion Capacity |  | day 1 | 
| BODE-Score | Changes in Bode-Score from baseline to day 19 | day 1 and 19 | 
| lung function |  | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD III/IV, Activity Monitoring, SenseWear, Vibration training, Galileo, Pulmonary rehabilitation