Evaluation of the Effects of Whole Body Vibration on the Lung Function of Patients With Stable COPD

Study Overview
=================
Brief Summary
-----------------
The typical clinical progression of COPD usually results in a decreased level of tolerable physical exertion for the patient. The avoidance of strenuous physical activity leads to a deteriorating level of physical fitness, which further decreases the patient's ability to undertake physical activities. Recent research has shown that whole body vibration has the potential to improve physical fitness of participants, including such measures as the 6 minute walking distance. However, information concerning lung function is lacking. The goal of the study is to test whether the use of whole body vibration training has an effect on the lung function of patients with stable COPD, or if the previously observed effects can be attributed to either pharmaceutical therapy or physical therapy interventions.

Official Title
-----------------
Evaluation of the Effects of Whole Body Vibration Training With the Galileo Training Device on the Lung Function of Patients With Stable COPD

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Device: Whole Body Vibration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable COPD (Gold II-IV) Signed understanding of participation The patients must be able to understand and follow the requirements of participation (Understanding of the German language) Exclusion Criteria: Acute thrombosis Hemoptysis Implants in the targeted training regions (joint implants) Acute joint inflammation, active arthrosis or arthropathy. Rheumatoid arthritis Acute tendinopathy in the targeted training regions Acute hernia Acute discopathy Fresh fracture in the targeted training regions Gall or kidney stones Wounds still in the process of healing Epilepsy Severe neurologic disorders (apoplexy, paralysis of upper and lower extremities) Severe circulatory disorders (Cardiac insufficiency NYHA > or = III, myocardial infarct less than one month prior, circulatory relevant rhythm disorders, idiopathic syncope) Tension pneumothorax Acute internal bleeding Current therapy with fluoroquinolone Alcohol/drug/medication abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Whole body vibration training as sham procedure (5Hz) 3 times a week, 3x2 minutes, for 6 weeks. | Device: Whole Body Vibration<br>* The principle of the Galileo vibration platform is a side alternating motion similar to a childrens seesaw. Both the amplitude of movement and the frequency of movement may be altered. Frequency may be controlled on the device and settings range from 5Hz to 30Hz. Amplitude of movement is set by spreading one's legs further apart from the midline. Control arm participants remain fixed at 5Hz through the 6 week training period, while intervention arm participants steadily increase their frequency to a maximum of 28Hz.<br>* Other names: Galileo Platform Novotec Medical;|
| Experimental: Intervention<br>Whole body vibration training (12 Hz up to 30 Hz) 3 times a week, 3x2 minutes, for 6 weeks. | Device: Whole Body Vibration<br>* The principle of the Galileo vibration platform is a side alternating motion similar to a childrens seesaw. Both the amplitude of movement and the frequency of movement may be altered. Frequency may be controlled on the device and settings range from 5Hz to 30Hz. Amplitude of movement is set by spreading one's legs further apart from the midline. Control arm participants remain fixed at 5Hz through the 6 week training period, while intervention arm participants steadily increase their frequency to a maximum of 28Hz.<br>* Other names: Galileo Platform Novotec Medical;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 |  | Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SGRQ-C: Saint George´s Respiratory Questionnaire for COPD Patients |  | Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2) | 
| mMRC: Modified British Medical Research Council |  | Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2) | 
| CAT: COPD Assessment Test |  | Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2) | 
| PHQ-9 (Brief Patient Health Questionnaire |  | Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2) | 
| SF-12: Short Form (12) Health Questionnaire |  | Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2) | 
| 6 Minute Walking Test |  | Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2) | 
| Chair Rising Test |  | Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2) | 
| Handheld Dynamometry Strength Testing of Extremities |  | Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2) | 
| Diffusion capacity for oxygen |  | Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2) | 
| Maximal inspiratory pressure |  | Baseline (T0), Change from baseline measured at end of six weeks of training (T1), Change from baseline measured at six week follow-up measurement (T2) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic obstructive pulmonary disease, Randomized controlled trial, Physical activity