- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00650715
Effects of Whole-Body Vibration Exercise on Serum IGF-1 in Fibromyalgia
March 31, 2008 updated by: Institut Nacional d'Educacio Fisica de Catalunya
Effect of Acute and Chronic Whole-Body Vibration Exercise on Serum Insulin-Like Growth Factor-1 Levels in Women With Fibromyalgia
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Barcelona, Spain, 08038
- Institut Nacional d'Educación Física de Catalunya
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: VG
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.
|
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 Comparator: CG
The Control Group (CG) underwent the same protocol of exercises than VG but without vibratory stimulus.
The CG continued with their usual pharmacological treatment.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum IGF-1 levels
Time Frame: Baseline, Week 1, Week 3, Week 6
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Baseline, Week 1, Week 3, Week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eduard Alentorn-Geli, MD, INEFC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
January 1, 2005
Study Completion (Actual)
January 1, 2005
Study Registration Dates
First Submitted
March 31, 2008
First Submitted That Met QC Criteria
March 31, 2008
First Posted (Estimate)
April 2, 2008
Study Record Updates
Last Update Posted (Estimate)
April 2, 2008
Last Update Submitted That Met QC Criteria
March 31, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WBVIGF1FM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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