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Effects of Vibration Training on Exercise Capacity in COPD-patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

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

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD III/IV, 6-Minutes-Walking-Distance, Vibration training, Galileo, Pulmonary rehabilitation

Eligibility Criteria

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

Inclusion Criteria:

  • Chronic obstructive pulmonary disease III/IV

Exclusion Criteria:

  • Severe exacerbations in the last 4 weeks prior to begin of study (definition of exacerbation: symptoms on more than 3 days with a relevant change in drug therapy (cortisone, antibiotics))
  • Severe disease other than COPD, that could influence the results of the study
  • Abuse of alcohol or drugs
  • Simultaneously participation in another study
  • Tachypnea (>30/min)
  • Severe exacerbation during rehabilitation
  • Cardiac insufficiency (NYHA IV)
  • Myocardial infarction during the last 6 weeks
  • Mental-health problem
  • Pregnancy
  • Known HIV-infection
  • Slipped disk
  • Acute discopathy
  • Acute thrombosis
  • Implants in trained regions of the body (lower extremities)
  • Acute inflammation of the locomotor system, active arthrosis or rheumatoid arthritis
  • Acute tendinopathy in trained regions of the body
  • Acute hernia
  • Fresh fractures, wounds or scars in trained regions of the body
  • Gallstones or stones in the urinary tract collection system

Sites / Locations

  • Schön Klinikum Berchtesgadener Land

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rehabilitation with vibration training

Rehabilitation without vibration training

Arm Description

Outcomes

Primary Outcome Measures

6-Minute-Walking-Distance
Change in 6-minute-walking-distance from baseline to day 19

Secondary Outcome Measures

Body Composition
Change in body composition from baseline to day 19
Isometric Maximum Handgrip Force
change in isometric max. handgrip force from baseline to day 19
BODE-Score
Change in Bode-Score from baseline to day 19
Lung Function
Arterial Blood Gas
Brain Natruretic Peptide (BNP)
change in BNP from baseline to day 19

Full Information

First Posted
April 1, 2011
Last Updated
April 10, 2019
Sponsor
Schön Klinik Berchtesgadener Land
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1. Study Identification

Unique Protocol Identification Number
NCT01380639
Brief Title
Effects of Vibration Training on Exercise Capacity in COPD-patients
Official Title
Effects of Vibration Training During a Three-week Rehabilitation on Exercise Capacity in Chronic Obstructive Pulmonary Disease (COPD) III/IV-Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2010 (Actual)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (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
The aim of this study is to investigate the exercise capacity in COPD-patients performing a vibration training additional to a standard three-week rehabilitation program in comparison to patients performing merely a rehabilitation program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD III/IV, 6-Minutes-Walking-Distance, Vibration training, Galileo, Pulmonary rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitation with vibration training
Arm Type
Experimental
Arm Title
Rehabilitation without vibration training
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
whole body vibration training
Intervention Description
performing squats for 3x3 minutes while using vibration platform three times a week
Primary Outcome Measure Information:
Title
6-Minute-Walking-Distance
Description
Change in 6-minute-walking-distance from baseline to day 19
Time Frame
day 1, day 19
Secondary Outcome Measure Information:
Title
Body Composition
Description
Change in body composition from baseline to day 19
Time Frame
day 1 and 19
Title
Isometric Maximum Handgrip Force
Description
change in isometric max. handgrip force from baseline to day 19
Time Frame
day 1, day 19
Title
BODE-Score
Description
Change in Bode-Score from baseline to day 19
Time Frame
day 1, day 19
Title
Lung Function
Time Frame
day 1
Title
Arterial Blood Gas
Time Frame
day 1
Title
Brain Natruretic Peptide (BNP)
Description
change in BNP from baseline to day 19
Time Frame
day 1, day 19

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic obstructive pulmonary disease III/IV Exclusion Criteria: Severe exacerbations in the last 4 weeks prior to begin of study (definition of exacerbation: symptoms on more than 3 days with a relevant change in drug therapy (cortisone, antibiotics)) Severe disease other than COPD, that could influence the results of the study Abuse of alcohol or drugs Simultaneously participation in another study Tachypnea (>30/min) Severe exacerbation during rehabilitation Cardiac insufficiency (NYHA IV) Myocardial infarction during the last 6 weeks Mental-health problem Pregnancy Known HIV-infection Slipped disk Acute discopathy Acute thrombosis Implants in trained regions of the body (lower extremities) Acute inflammation of the locomotor system, active arthrosis or rheumatoid arthritis Acute tendinopathy in trained regions of the body Acute hernia Fresh fractures, wounds or scars in trained regions of the body Gallstones or stones in the urinary tract collection system
Facility Information:
Facility Name
Schön Klinikum Berchtesgadener Land
City
Schönau am Königssee
ZIP/Postal Code
83471
Country
Germany

12. IPD Sharing Statement

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Effects of Vibration Training on Exercise Capacity in COPD-patients

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