Clinical trial NCT02679677: Evaluation of the Effects of Whole Body Vibration on the Lung Function of Patients With Stable COPD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Chronic obstructive pulmonary disease
Randomized controlled trial
Physical activity
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: National Center for Tumor Diseases, Heidelberg
First posted: 2016-02-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: FEV1
timeFrame: 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 outcomes:
measure: SGRQ-C: Saint George´s Respiratory Questionnaire for COPD Patients
timeFrame: 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)
measure: mMRC: Modified British Medical Research Council
timeFrame: 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)
measure: CAT: COPD Assessment Test
timeFrame: 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)
measure: PHQ-9 (Brief Patient Health Questionnaire
timeFrame: 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)
measure: SF-12: Short Form (12) Health Questionnaire
timeFrame: 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)
measure: 6 Minute Walking Test
timeFrame: 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)
measure: Chair Rising Test
timeFrame: 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)
measure: Handheld Dynamometry Strength Testing of Extremities
timeFrame: 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)
measure: Diffusion capacity for oxygen
timeFrame: 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)
measure: Maximal inspiratory pressure
timeFrame: 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)
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik at Heidelberg University Hospital
city: Marburg
country: Germany
facility: University Clinic Gießen and Marburg GmbH, Marburg Campus
Study officials:
affiliation: University Hospital Heidelberg
name: Felix Herth, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: