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

COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679677
• Other study ID #: S-607/2014
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2022
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• Whole Body Vibration
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.

Locations

Country	Name	City	State
Germany	Thoraxklinik at Heidelberg University Hospital	Heidelberg
Germany	University Clinic Gießen and Marburg GmbH, Marburg Campus	Marburg

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	National Center for Tumor Diseases, Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)