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Cardiorespiratory Response During Whole Body Vibration Training in Patients With Chronic Lung Disease

Primary Purpose

Chronic Obstructive Lung Disease (n=10), Interstitial Lung Disease (n=10)

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Whole body vibration
Sponsored by
Schön Klinik Berchtesgadener Land
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Obstructive Lung Disease (n=10) focused on measuring Whole body vibration, cardiorespiratory response

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schön Klinik Berchtesgadener Land

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Whole body vibration in COPD

Whole body vibration in ILD

Arm Description

Patients with COPD GOLD III or IV

PAtients with interstitial lung disease

Outcomes

Primary Outcome Measures

peak oxygen consumption (VO2 peak)
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.

Secondary Outcome Measures

heart rate (HR)
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.
minute ventilation (VE)
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.
perceived exertion for dyspnea and leg fatigue (Borg-scale)
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.
Alveolar-arterial oxygen difference (AaDO2)
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.
breathing frequency (BF)
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.
peak carbon-dioxide consumption (VCO2 peak)
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.

Full Information

First Posted
June 24, 2013
Last Updated
February 23, 2016
Sponsor
Schön Klinik Berchtesgadener Land
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1. Study Identification

Unique Protocol Identification Number
NCT01898143
Brief Title
Cardiorespiratory Response During Whole Body Vibration Training in Patients With Chronic Lung Disease
Official Title
Cardiorespiratory Response During Whole Body Vibration Training in Patients With Chronic Obstructive Pulmonary Disease (COPD) or Interstitial Lung Disease (ILD)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Lung Disease (n=10), Interstitial Lung Disease (n=10)
Keywords
Whole body vibration, cardiorespiratory response

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whole body vibration in COPD
Arm Type
Other
Arm Description
Patients with COPD GOLD III or IV
Arm Title
Whole body vibration in ILD
Arm Type
Other
Arm Description
PAtients with interstitial lung disease
Intervention Type
Other
Intervention Name(s)
Whole body vibration
Primary Outcome Measure Information:
Title
peak oxygen consumption (VO2 peak)
Description
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.
Time Frame
during 1 exercise session
Secondary Outcome Measure Information:
Title
heart rate (HR)
Description
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.
Time Frame
during 1 exercise session
Title
minute ventilation (VE)
Description
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.
Time Frame
during 1 exercise session
Title
perceived exertion for dyspnea and leg fatigue (Borg-scale)
Description
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.
Time Frame
during 1 exercise session
Title
Alveolar-arterial oxygen difference (AaDO2)
Description
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.
Time Frame
during 1 exercise session
Title
breathing frequency (BF)
Description
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.
Time Frame
during 1 exercise session
Title
peak carbon-dioxide consumption (VCO2 peak)
Description
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.
Time Frame
during 1 exercise session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Schön Klinik Berchtesgadener Land
City
Schönau am Königssee
ZIP/Postal Code
83471
Country
Germany

12. IPD Sharing Statement

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Cardiorespiratory Response During Whole Body Vibration Training in Patients With Chronic Lung Disease

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