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

NCT ID: NCT02679677

Last Updated: 2022-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-08-31

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Whole body vibration training as sham procedure (5Hz) 3 times a week, 3x2 minutes, for 6 weeks.

Group Type: SHAM_COMPARATOR

Whole Body Vibration

Intervention Type: DEVICE

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.

Intervention

Whole body vibration training (12 Hz up to 30 Hz) 3 times a week, 3x2 minutes, for 6 weeks.

Group Type: EXPERIMENTAL

Whole Body Vibration

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Galileo; Galileo Platform Novotec Medical

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Tumor Diseases, Heidelberg

OTHER

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Felix JF Herth

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felix Herth, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

Thoraxklinik at Heidelberg University Hospital

Heidelberg, , Germany

University Clinic Gießen and Marburg GmbH, Marburg Campus

Marburg, , Germany

Countries

Germany

Other Identifiers

S-607/2014

Identifier Type: -

Identifier Source: org_study_id