NCT00650715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2004

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed
Last Updated

April 2, 2008

Status Verified

March 1, 2008

Enrollment Period

1 month

First QC Date

March 31, 2008

Last Update Submit

March 31, 2008

Conditions

Keywords

FibromyalgiaWhole-Body vibrationExerciseIGF-1

Outcome Measures

Primary Outcomes (1)

  • Serum IGF-1 levels

    Baseline, Week 1, Week 3, Week 6

Study Arms (2)

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.

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.

Device: Placebo Whole-body vibration exercise

Interventions

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.

VG

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.

CG

Eligibility Criteria

Age35 Years - 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed of fibromyalgia according to the American College of Rheumatology criteria for at least three years.

You may not qualify if:

  • Orthopedic limitation, or cardiovascular, pulmonary, or metabolic disease that would preclude exercise.
  • Participation in any other study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Nacional d'Educación Física de Catalunya

Barcelona, Barcelona, 08038, Spain

Location

MeSH Terms

Conditions

FibromyalgiaMotor Activity

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesBehavior

Study Officials

  • Eduard Alentorn-Geli, MD

    INEFC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 31, 2008

First Posted

April 2, 2008

Study Start

December 1, 2004

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

April 2, 2008

Record last verified: 2008-03

Locations