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

NCT02679677 | Completed

• 1 other identifier: S-607/2014
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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

Keywords

Chronic obstructive pulmonary disease; Randomized controlled trial; Physical activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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)

Study Arms (2)

Control

SHAM COMPARATOR

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

Device: Whole Body Vibration

Intervention

EXPERIMENTAL

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

Device: Whole Body Vibration

Interventions

Whole Body Vibration 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.

Also known as: Galileo, Galileo Platform Novotec Medical

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead
• National Center for Tumor Diseases, Heidelberg: collaborator

Study Sites (2)

Thoraxklinik at Heidelberg University Hospital

Heidelberg, 69126, Germany

Location

University Clinic Gießen and Marburg GmbH, Marburg Campus

Marburg, 35033, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Felix Herth, Prof. Dr. med.

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: February 10, 2016
• Study Start: April 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

DE (2)