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

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

GALILEO

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring whole body vibration, muscle function, cystic fibrosis, mechanography, chair-rising-test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

clinical diagnosis of Cystic Fibrosis
age older than 18 years

Exclusion Criteria:

hypersplenic syndrome
acute arthritis or osteomyelitis

Sites / Locations

CF Center Cologne, University Children's Hospital

Outcomes

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

Full Information

NCT ID

NCT00388466

First Posted

October 13, 2006

Last Updated

October 13, 2006

Sponsor

University of Cologne

1. Study Identification

Unique Protocol Identification Number

NCT00388466

Brief Title

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

Official Title

Cystic Fibrosis: Improvement of Muscle Force and Function by Whole Body Vibration Exercise

Study Type

Interventional

2. Study Status

Record Verification Date

October 2006

Overall Recruitment Status

Completed

Study Start Date

June 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Cologne

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

whole body vibration, muscle function, cystic fibrosis, mechanography, chair-rising-test

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

GALILEO

Primary Outcome Measure Information:

Title

muscle force at the beginning of the study and after 3 months

Title

muscle power at the beginning of the study and after 3 months

Secondary Outcome Measure Information:

Title

pulmonary function testing at the beginning of the study and after 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: clinical diagnosis of Cystic Fibrosis age older than 18 years Exclusion Criteria: hypersplenic syndrome acute arthritis or osteomyelitis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eckhard Schoenau, Prof.

Organizational Affiliation

University Children´s Hospital Cologne, Germany

Official's Role

Study Chair

Facility Information:

Facility Name

CF Center Cologne, University Children's Hospital

City

Cologne

ZIP/Postal Code

50924

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

16327004

Citation

Fricke O, Weidler J, Tutlewski B, Schoenau E. Mechanography--a new device for the assessment of muscle function in pediatrics. Pediatr Res. 2006 Jan;59(1):46-9. doi: 10.1203/01.pdr.0000191580.07644.1c. Epub 2005 Dec 2.

Results Reference

background

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

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