- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01898143
Cardiorespiratory Response During Whole Body Vibration Training in Patients With Chronic Lung Disease
February 23, 2016 updated by: Klaus Kenn, Schön Klinik Berchtesgadener Land
Cardiorespiratory Response During Whole Body Vibration Training in Patients With Chronic Obstructive Pulmonary Disease (COPD) or Interstitial Lung Disease (ILD)
Whole body vibration training seems to be a useful adjunct in exercise training in patients with severe COPD.
The basic principle relies on reflectory muscle contractions caused by a vibration stimulus.
Until now the impact of whole body vibration training on cardiopulmonary parameters remained unknown.
Therefore aim of this study is to investigate cardiopulmonary parameters during whole body vibration training in patients with chronic lung disease.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Schönau am Königssee, Germany, 83471
- Schön Klinik Berchtesgadener Land
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- COPD stage III or IV according to the Global Initiative for chronic obstructive lung disease [GOLD])
- Interstitial Lung disease (forced vital capacity (FVC) < 70% pred., diffusion capacity of lung for carbon monoxide (DLCO) 30-70% pred.)
Exclusion Criteria:
- Oxygen therapy during exercise required
- Severe exacerbation of lung disease, with necessity of change in medication or persistent symptoms > 3days
- activated arthrosis /arthropathy/ rheumatoid Arthritis/ acute discopathy
- acute thrombosis
- acute musculoskeletal inflammation
- Epilepsy
- Gallstones
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Whole body vibration in COPD
Patients with COPD GOLD III or IV
|
|
Other: Whole body vibration in ILD
PAtients with interstitial lung disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
peak oxygen consumption (VO2 peak)
Time Frame: during 1 exercise session
|
subjects perform several short bouts (1 to 3 minutes duration) of squatting exercise with or without whole body vibration.
The peak values of each single part is used for comparison.
|
during 1 exercise session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
heart rate (HR)
Time Frame: during 1 exercise session
|
subjects perform several short bouts (1 to 3 minutes duration) of squatting exercise with or without whole body vibration.
The peak values of each single part is used for comparison.
|
during 1 exercise session
|
minute ventilation (VE)
Time Frame: during 1 exercise session
|
subjects perform several short bouts (1 to 3 minutes duration) of squatting exercise with or without whole body vibration.
The peak values of each single part is used for comparison.
|
during 1 exercise session
|
perceived exertion for dyspnea and leg fatigue (Borg-scale)
Time Frame: during 1 exercise session
|
subjects perform several short bouts (1 to 3 minutes duration) of squatting exercise with or without whole body vibration.
The peak values of each single part is used for comparison.
|
during 1 exercise session
|
Alveolar-arterial oxygen difference (AaDO2)
Time Frame: during 1 exercise session
|
subjects perform several short bouts (1 to 3 minutes duration) of squatting exercise with or without whole body vibration.
The peak values of each single part is used for comparison.
|
during 1 exercise session
|
breathing frequency (BF)
Time Frame: during 1 exercise session
|
subjects perform several short bouts (1 to 3 minutes duration) of squatting exercise with or without whole body vibration.
The peak values of each single part is used for comparison.
|
during 1 exercise session
|
peak carbon-dioxide consumption (VCO2 peak)
Time Frame: during 1 exercise session
|
subjects perform several short bouts (1 to 3 minutes duration) of squatting exercise with or without whole body vibration.
The peak values of each single part is used for comparison.
|
during 1 exercise session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
June 24, 2013
First Submitted That Met QC Criteria
July 10, 2013
First Posted (Estimate)
July 12, 2013
Study Record Updates
Last Update Posted (Estimate)
February 24, 2016
Last Update Submitted That Met QC Criteria
February 23, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SpiroErgoGalileo-2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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