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

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ClinicalTrials.gov Identifier: NCT02679677
Recruitment Status : Unknown
Verified February 2016 by Felix JF Herth, Heidelberg University.
Recruitment status was:  Recruiting
First Posted : February 10, 2016
Last Update Posted : February 10, 2016
Sponsor:
Collaborator:
National Center for Tumor Diseases, Heidelberg
Information provided by (Responsible Party):
Felix JF Herth, Heidelberg University

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.


Condition or disease Intervention/treatment Phase
COPD Device: Whole Body Vibration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : April 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

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




Primary Outcome Measures :
  1. FEV1 [ Time Frame: 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 :
  1. SGRQ-C: Saint George´s Respiratory Questionnaire for COPD Patients [ Time Frame: 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) ]
  2. mMRC: Modified British Medical Research Council [ Time Frame: 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) ]
  3. CAT: COPD Assessment Test [ Time Frame: 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) ]
  4. PHQ-9 (Brief Patient Health Questionnaire [ Time Frame: 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) ]
  5. SF-12: Short Form (12) Health Questionnaire [ Time Frame: 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. 6 Minute Walking Test [ Time Frame: 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) ]
  7. Chair Rising Test [ Time Frame: 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) ]
  8. Handheld Dynamomety Strength Testing of Extremities [ Time Frame: 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) ]
  9. Diffusion capacity for oxygen [ Time Frame: 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) ]
  10. Maximal inspiratory pressure [ Time Frame: 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679677


Contacts
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Contact: Simone Hummler, Dr. med. +49 6221-396 8074 simone.hummler@med.uni-heidelberg.de
Contact: Florian Bornitz, Dr. med. +49 6221-396 8074 florian.bornitz@med.uni-heidelberg.de

Locations
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Germany
Thoraxklinik at Heidelberg University Hospital Recruiting
Heidelberg, Germany, 69126
Contact: Simone Hummler, Dr. med.    +49 6221-396 8074      
University Clinic Gießen and Marburg GmbH, Marburg Campus Recruiting
Marburg, Germany, 35033
Contact: Andreas R Koczulla, Dr. med.    +49 6421-586 3691    koczulla@med.uni-marburg.de   
Sponsors and Collaborators
Heidelberg University
National Center for Tumor Diseases, Heidelberg
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Responsible Party: Felix JF Herth, Medical Director, Heidelberg University
ClinicalTrials.gov Identifier: NCT02679677    
Other Study ID Numbers: S-607/2014
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Felix JF Herth, Heidelberg University:
Chronic obstructive pulmonary disease
Randomized controlled trial
Physical activity