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

This study has been completed.
Sponsor:
Information provided by:
Institut Nacional d'Educacio Fisica de Catalunya
ClinicalTrials.gov Identifier:
NCT00650715
First received: March 31, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Fibromyalgia
Hormonal Responses to Exercise in Patients With Fibromyalgia.
Device: Vibratory platform, PowerPlate®, Badhoevendorp, Netherlands
Device: Placebo Whole-body vibration exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Acute and Chronic Whole-Body Vibration Exercise on Serum Insulin-Like Growth Factor-1 Levels in Women With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Institut Nacional d'Educacio Fisica de Catalunya:

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

Enrollment: 24
Study Start Date: December 2004
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 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.
Device: 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.

  Eligibility

Ages Eligible for Study:   35 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00650715

Locations
Spain
Institut Nacional d'Educación Física de Catalunya
Barcelona, Spain, 08038
Sponsors and Collaborators
Institut Nacional d'Educacio Fisica de Catalunya
Investigators
Principal Investigator: Eduard Alentorn-Geli, MD INEFC
  More Information

No publications provided

Responsible Party: Eduard Alentorn-Geli, MD, INEFC
ClinicalTrials.gov Identifier: NCT00650715     History of Changes
Other Study ID Numbers: WBVIGF1FM
Study First Received: March 31, 2008
Last Updated: March 31, 2008
Health Authority: Spain: Ethics Committee

Keywords provided by Institut Nacional d'Educacio Fisica de Catalunya:
Fibromyalgia
Whole-Body vibration
Exercise
IGF-1

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 21, 2014