FibromyalgiaNCT00650715
Effects of Whole-Body Vibration Exercise on Serum IGF-1 in Fibromyalgia
A study testing Vibratory platform, PowerPlate®, Badhoevendorp, Netherlands in people with Fibromyalgia and Hormonal Responses to Exercise in Patients With Fibromyalgia., run by Institut Nacional d'Educacio Fisica de Catalunya at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 35 to 69 years, women only
- Conditions the study is for
- Fibromyalgia, Hormonal Responses to Exercise in Patients With Fibromyalgia.
- What is being tested?
- Vibratory platform, PowerPlate®, Badhoevendorp, Netherlands
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2004to Jan 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed of fibromyalgia according to the American College of Rheumatology criteria for at least three years.
Who cannot join
- Orthopedic limitation, or cardiovascular, pulmonary, or metabolic disease that would preclude exercise.
- Participation in any other study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut Nacional d'Educación Física de Catalunya
Barcelona, Barcelona, 08038
About this study
Official title: 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.
- Being tested
- Vibratory platform, PowerPlate®, Badhoevendorp, Netherlands, Placebo Whole-body vibration exercise
- Keywords
- Fibromyalgia, Whole-Body vibration, Exercise, IGF-1
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibratory platform, PowerPlate®, Badhoevendorp, NetherlandsDevice
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 exerciseDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| VG | Active comparator | 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. Receives: Device: Vibratory platform, PowerPlate®, Badhoevendorp, Netherlands |
| CG | Placebo comparator | The Control Group (CG) underwent the same protocol of exercises than VG but without vibratory stimulus. The CG continued with their usual pharmacological treatment. Receives: Device: Placebo Whole-body vibration exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum IGF-1 levels
Measured: Baseline, Week 1, Week 3, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startDec 2004
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Nacional d'Educacio Fisica de Catalunya
- Sponsor type
- University, hospital or other
- Investigators
- Eduard Alentorn-Geli, MD, Principal investigator, INEFC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650715
- Sponsor's protocol ID
- WBVIGF1FM
- Status last verified
- Mar 2008
- First submitted
- 31 Mar 2008
- Last updated
- 2 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acute and Chronic Whole-Body Vibration Exercise on Serum Insulin-Like Growth Factor-1 Levels in Women With Fibromyalgia
- ClinicalTrials.gov ID
- NCT00650715
- Acronym / sponsor ID
- WBVIGF1FM
- Keywords
- Fibromyalgia, Whole-Body vibration, Exercise, IGF-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Institut Nacional d'Educacio Fisica de CatalunyaUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 2 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VG | Active comparator | Device: Vibratory platform, PowerPlate®, Badhoevendorp, NetherlandsVibration 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. |
| CG | Placebo comparator | Device: Placebo Whole-body vibration exerciseThe Control Group (CG) underwent the same protocol of exercises than VG but without vibratory stimulus. The CG continued with their usual pharmacological treatment. |
Who may qualify
- Ages
- 35 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed of fibromyalgia according to the American College of Rheumatology criteria for at least three years.
Key exclusion criteria (2 listed)
- Orthopedic limitation, or cardiovascular, pulmonary, or metabolic disease that would preclude exercise.
- Participation in any other study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibratory platform, PowerPlate®, Badhoevendorp, NetherlandsSix 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. | Device | VG |
| Placebo Whole-body vibration exerciseSix 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. | Device | CG |
Primary outcome
Serum IGF-1 levels
Time frame: Baseline, Week 1, Week 3, Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduard Alentorn-Geli, MD principal investigator
INEFC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibratory platform, PowerPlate®, Badhoevendorp, Netherlands in people with Fibromyalgia and Hormonal Responses to Exercise in Patients With Fibromyalgia., run by Institut Nacional d'Educacio Fisica de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum IGF-1 levels (time frame: Baseline, Week 1, Week 3, Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2008.