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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00650715
Other study ID # WBVIGF1FM
Secondary ID
Status Completed
Phase N/A
First received March 31, 2008
Last updated March 31, 2008
Start date December 2004
Est. completion date January 2005

Study information

Verified date March 2008
Source Institut Nacional d'Educacio Fisica de Catalunya
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date January 2005
Est. primary completion date January 2005
Accepts healthy volunteers No
Gender Female
Age group 35 Years to 69 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Vibratory platform, PowerPlate®, Badhoevendorp, Netherlands
Six exercises (static and dynamic tasks) while standing on a Whole-body vibration platform. The six exercises (30 seconds each) were repeated six times with a recovery of 3 minutes in between. The Whole-body vibration intensity was kept constant at 30 Hz of frequency and 2 mm of amplitude.
Placebo Whole-body vibration exercise
Six exercises (static and dynamic tasks) while standing on a Whole-body vibration platform. The six exercises (30 seconds each) were repeated six times with a recovery of 3 minutes in between. All exercises were performed without the influence of a vibratory stimulus.

Locations

Country Name City State
Spain Institut Nacional d'Educación Física de Catalunya Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Institut Nacional d'Educacio Fisica de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum IGF-1 levels Baseline, Week 1, Week 3, Week 6 Yes
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