Effects of Whole-Body Vibration Exercise on Serum IGF-1 in Fibromyalgia - Tabular View

Tracking Information

First Received Date ^ICMJE

March 31, 2008

Last Updated Date

March 31, 2008

Start Date ^ICMJE

December 2004

Primary Completion Date

January 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Serum IGF-1 levels [ Time Frame: Baseline, Week 1, Week 3, Week 6 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Effects of Whole-Body Vibration Exercise on Serum IGF-1 in Fibromyalgia

Official Title ^ICMJE

Effect of Acute and Chronic Whole-Body Vibration Exercise on Serum Insulin-Like Growth Factor-1 Levels in Women With Fibromyalgia

Brief Summary

The purpose of this study was to investigate the acute and chronic effect of whole-body vibration exercise on serum insulin-like growth factor-1 levels in women with fibromyalgia (FM). It was hypothesized that women with FM would exhibit an increase in IGF-1 following both acute and chronic WBV. Twenty-four women with FM were randomized into two groups: Vibration Group (VG) and Control Group (CG). The VG underwent a protocol with WBV exercise twice a week for a total of six weeks, whereas the CG performed the same protocol without vibratory stimulus. Both groups continued with their usual pharmacological treatment. Serum IGF-1 levels were determined using Enzyme-Linked Immunosorbent Assay (ELISA). To test the effect of chronic WBV, serum IGF-1 measurements were taken at baseline and at weeks 1,3, and 6 of intervention. To test the effect of acute WBV, within week 1, serum IGF-1 measurements were taken before and immediately following a session of WBV.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment

Condition ^ICMJE

Fibromyalgia
Hormonal Responses to Exercise in Patients With Fibromyalgia.

Intervention ^ICMJE

Device: Vibratory platform, PowerPlate®, Badhoevendorp, Netherlands
Device: Placebo Whole-body vibration exercise

Study Arms / Comparison Groups

Active Comparator: Vibration Group (VG) underwent a protocol with whole-body vibration exercise twice a week for a total of six weeks. The group continued with their usual pharmacological treatment.
Placebo Comparator: The Control Group (CG) underwent the same protocol of exercises than VG but without vibratory stimulus. The CG continued with their usual pharmacological treatment.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2005

Primary Completion Date

January 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients diagnosed of fibromyalgia according to the American College of Rheumatology criteria for at least three years.

Exclusion Criteria:

Orthopedic limitation, or cardiovascular, pulmonary, or metabolic disease that would preclude exercise.
Participation in any other study.

Gender

Female

Ages

35 Years to 69 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT ID ^ICMJE

NCT00650715

Responsible Party

Eduard Alentorn-Geli, MD, INEFC

Study ID Numbers ^ICMJE

WBVIGF1FM

Study Sponsor ^ICMJE

Institut Nacional d'Educacio Fisica de Catalunya

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Eduard Alentorn-Geli, MD

INEFC

Information Provided By

Institut Nacional d'Educacio Fisica de Catalunya

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP