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Whole Body Vibration - a New Therapeutic Approach to Improve Muscle Function in CF

This study has been completed.
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00388466
First received: October 13, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

The purpose of this study is to evaluate the effects of whole body vibration (WBV) on muscle function in adult CF-patients.


Condition Intervention
Cystic Fibrosis
 Device: GALILEO

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cystic Fibrosis: Improvement of Muscle Force and Function by Whole Body Vibration Exercise

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • muscle force at the beginning of the study and after 3 months
  • muscle power at the beginning of the study and after 3 months

Secondary Outcome Measures:
  • pulmonary function testing at the beginning of the study and after 3 months

Estimated Enrollment: 10
Study Start Date: June 2005
Estimated Study Completion Date: August 2006
Detailed Description:

Cystic Fibrosis (CF) is the most common chronic hereditary disease in Caucasians. Due to improved therapy and better understanding of the disease, life expectancy has risen to an average of 38 years and is continuing to rise. With the increased life-expectancy it becomes even more important to maintain functional activity as part of quality of life. Mechanical stimulation in form of whole body vibration (WBV) is a new type of exercise currently tested in sports, geriatrics and rehabilitation. It has recently been found to be a safe and efficient method to activate muscular activity via stretch reflexes leading to improvement of muscular performance, body balance and physical functioning.

10 patients of the CF Center Cologne, Germany, took part in the Galileo study. They were provided by the vibrating platform (Galileo 2000)for whole body vibration training at home. The patients were standing in an upright position receiving vertical vibration of frequencies between 20-25 Hz. This vibration exercise evokes muscle contractions via stretch reflexes improving muscular activity. The training schedule consisted of three 3-minute sessions twice a day 5 days per week for 3 months.

Every 4 weeks the patients were seen for assessment of muscle function to evaluate the effects of this new intervention.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • clinical diagnosis of Cystic Fibrosis
  • age older than 18 years

Exclusion Criteria:

  • hypersplenic syndrome
  • acute arthritis or osteomyelitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388466

Locations
Germany
CF Center Cologne, University Children`s Hospital
Cologne, Germany, 50924
Sponsors and Collaborators
University of Cologne
Investigators
Study Chair: Eckhard Schoenau, Prof. University Children´s Hospital Cologne, Germany
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00388466     History of Changes
Other Study ID Numbers: 05-005
Study First Received: October 13, 2006
Last Updated: October 13, 2006
Health Authority: Germany: Ethics Commission

Keywords provided by University of Cologne:
whole body vibration
muscle function
cystic fibrosis
mechanography
chair-rising-test

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013