Back to resultsEffects of Whole-Body Vibration Exercise on Serum IGF-1 in Fibromyalgia
Primary Purpose
Fibromyalgia, Hormonal Responses to Exercise in Patients With Fibromyalgia.
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Vibratory platform, PowerPlate®, Badhoevendorp, Netherlands
Placebo Whole-body vibration exercise
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Whole-Body vibration, Exercise, IGF-1
Eligibility Criteria
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.
Sites / Locations
- Institut Nacional d'Educación Física de Catalunya
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
VG
CG
Arm Description
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.
The Control Group (CG) underwent the same protocol of exercises than VG but without vibratory stimulus. The CG continued with their usual pharmacological treatment.
Outcomes
Primary Outcome Measures
Serum IGF-1 levels
Secondary Outcome Measures
Full Information
NCT ID
NCT00650715
First Posted
March 31, 2008
Last Updated
March 31, 2008
Sponsor
Institut Nacional d'Educacio Fisica de Catalunya
1. Study Identification
Unique Protocol Identification Number
NCT00650715
Brief Title
Effects of Whole-Body Vibration Exercise on Serum IGF-1 in Fibromyalgia
Official Title
Effect of Acute and Chronic Whole-Body Vibration Exercise on Serum Insulin-Like Growth Factor-1 Levels in Women With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Institut Nacional d'Educacio Fisica de Catalunya
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Hormonal Responses to Exercise in Patients With Fibromyalgia.
Keywords
Fibromyalgia, Whole-Body vibration, Exercise, IGF-1
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VG
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CG
Arm Type
Placebo Comparator
Arm Description
The Control Group (CG) underwent the same protocol of exercises than VG but without vibratory stimulus. The CG continued with their usual pharmacological treatment.
Intervention Type
Device
Intervention Name(s)
Vibratory platform, PowerPlate®, Badhoevendorp, Netherlands
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo Whole-body vibration exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum IGF-1 levels
Time Frame
Baseline, Week 1, Week 3, Week 6
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduard Alentorn-Geli, MD
Organizational Affiliation
INEFC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Nacional d'Educación Física de Catalunya
City
Barcelona
ZIP/Postal Code
08038
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Effects of Whole-Body Vibration Exercise on Serum IGF-1 in Fibromyalgia
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