Trial record 4 of 586 for:
"Fibromyalgia"
Effects of Whole-Body Vibration Exercise on Serum IGF-1 in Fibromyalgia
This study has been completed.
Sponsor:
Institut Nacional d'Educacio Fisica de Catalunya
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
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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 (Adult, Senior) |
| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00650715
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
| 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 |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on September 28, 2016