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Pool-based Exercise in Fibromyalgia Management

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ClinicalTrials.gov Identifier: NCT00550641
Recruitment Status : Completed
First Posted : October 30, 2007
Last Update Posted : April 6, 2010
Sponsor:
Information provided by:
Universidad de Granada

Study Description
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Brief Summary:
Pharmacologic treatment remains the primary therapeutic approach in fibromyalgia management, but different non-pharmacologic measures, especially physical therapies and psychologically-based interventions, have also shown to be effective in the treatment of this disease. The objective of the present randomized controlled trial is to compare the efficacy and tolerability of two different modalities of active low-impact exercise in warm water: stretching and Ai Chi. Each group of patients will receive 18 physiotherapy sessions lasting 60 minutes and will be evaluated at baseline, at treatment termination, and after 4 and 12 weeks of follow up. Main outcome measures are the Fibromyalgia Impact Questionnaire (FIQ) and the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome measures include the Beck Depression Inventory (BDI), the State and Trait Anxiety Inventory (STAI), and the SF-12 Health Survey (SF-12. Data analysis will be done using repeated measures ANOVA, unpaired Student's t test, and effect sizes' estimation (ES).

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: physical therapy Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pool-based Exercise in Fibromyalgia Management: a Prospective Randomized Comparison Between Stretching and Ai Chi
Study Start Date : March 2006
Actual Study Completion Date : December 2006

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1 Other: physical therapy
physical therapy in warm pool performing stretching
Experimental: 2 Other: physical therapy
physical therapy in warm pool performing Ai Chi


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in fibromyalgia symptomatology [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  1. Improvement in sleep, depressive and anxiety symptomatology and quality of life [ Time Frame: 18 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of fibromyalgia according to the ACR criteria
  • 18 years or older
  • written informed consent to participate

Exclusion Criteria:

  • unable to tolerate warm chlorinated water
  • associated medical condition contraindicating exercise in warm water
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550641


Locations
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Spain
Hospital Universitario "Virgen de las Nieves"
Granada, Spain, 18012
Sponsors and Collaborators
Universidad de Granada
Investigators
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Study Director: Elena P. Calandre Professor of Clinical Pharmacology
Principal Investigator: Mª Luz Rodriguez-Claro physiotherapist
More Information
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Publications of Results:

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ClinicalTrials.gov Identifier: NCT00550641    
Other Study ID Numbers: ML-2006
First Posted: October 30, 2007    Key Record Dates
Last Update Posted: April 6, 2010
Last Verified: September 2007
Keywords provided by Universidad de Granada:
fibromyalgia
pool-based exercise
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases