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

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

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Device: Whole Body Vibration

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69126
    • Thoraxklinik at Heidelberg University Hospital
  • Marburg, Germany, 35033
    • University Clinic Gießen and Marburg GmbH, Marburg Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control; Whole body vibration training as sham procedure (5Hz) 3 times a week, 3x2 minutes, for 6 weeks.	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.; Other Names: Galileo; Galileo Platform Novotec Medical
Experimental: Intervention; Whole body vibration training (12 Hz up to 30 Hz) 3 times a week, 3x2 minutes, for 6 weeks.	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.; Other Names: Galileo; Galileo Platform Novotec Medical

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Heidelberg University
• Collaborators: National Center for Tumor Diseases, Heidelberg
• Investigators: Principal Investigator: Felix Herth, Prof. Dr. med., University Hospital Heidelberg

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: January 18, 2016
• First Submitted That Met QC Criteria: February 7, 2016
• First Posted (Estimate): February 10, 2016

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Physical activity; Chronic obstructive pulmonary disease
• Other Study ID Numbers: S-607/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes