Effects of Vibration Training on Exercise Capacity in COPD-patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier:
NCT01380639
First received: April 1, 2011
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Other: whole body vibration training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Vibration Training During a Three-week Rehabilitation on Exercise Capacity in Chronic Obstructive Pulmonary Disease (COPD) III/IV-Patients

Resource links provided by NLM:


Further study details as provided by Klinikum Berchtesgadener Land der Schön-Kliniken:

Primary Outcome Measures:
  • 6-Minute-Walking-Distance [ Time Frame: day 1, day 19 ] [ Designated as safety issue: Yes ]
    Change in 6-minute-walking-distance from baseline to day 19


Secondary Outcome Measures:
  • Body Composition [ Time Frame: day 1 and 19 ] [ Designated as safety issue: No ]
    Change in body composition from baseline to day 19

  • Isometric Maximum Handgrip Force [ Time Frame: day 1, day 19 ] [ Designated as safety issue: No ]
    change in isometric max. handgrip force from baseline to day 19

  • BODE-Score [ Time Frame: day 1, day 19 ] [ Designated as safety issue: No ]
    Change in Bode-Score from baseline to day 19

  • Lung Function [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Arterial Blood Gas [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Brain Natruretic Peptide (BNP) [ Time Frame: day 1, day 19 ] [ Designated as safety issue: No ]
    change in BNP from baseline to day 19


Enrollment: 72
Study Start Date: September 2010
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rehabilitation with vibration training Other: whole body vibration training
performing squats for 3x3 minutes while using vibration platform three times a week
No Intervention: Rehabilitation without vibration training

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380639

Locations
Germany
Schön Klinikum Berchtesgadener Land
Schönau am Königssee, Germany, 83471
Sponsors and Collaborators
Klinikum Berchtesgadener Land der Schön-Kliniken
  More Information

No publications provided

Responsible Party: Klaus Kenn, MD, Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier: NCT01380639     History of Changes
Other Study ID Numbers: BGL-Ga-6MGT-0810
Study First Received: April 1, 2011
Results First Received: September 27, 2013
Last Updated: September 27, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Klinikum Berchtesgadener Land der Schön-Kliniken:
COPD III/IV
6-Minutes-Walking-Distance
Vibration training
Galileo
Pulmonary rehabilitation

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 11, 2014