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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388466
• Other study ID #: 05-005
• Status: Completed
• Phase: N/A
• First received: October 13, 2006
• Last updated: October 13, 2006
• Start date: June 2005
• Est. completion date: August 2006

Study information

• Verified date: October 2006
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• clinical diagnosis of Cystic Fibrosis

• age older than 18 years

Exclusion Criteria:

• hypersplenic syndrome

• acute arthritis or osteomyelitis

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• GALILEO

Locations

Country	Name	City	State
Germany	CF Center Cologne, University Children`s Hospital	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. Epub 2005 Dec 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle force at the beginning of the study and after 3 months
Primary	muscle power at the beginning of the study and after 3 months
Secondary	pulmonary function testing at the beginning of the study and after 3 months