NCT00550641|CompletedPhase 4
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Sponsor study identifier
interventional
90
1 country
1
Study Start
March 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
December 2006
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2006
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2006
Date type not reportedThis date has not been verified as actual or estimated.
December 2006
Actual (reported)October 26, 2007
Actual (reported)October 30, 2007
Actual (reported)Improvement in fibromyalgia symptomatology
18 weeks
Improvement in sleep, depressive and anxiety symptomatology and quality of life
18 weeks
physical therapy in warm pool performing stretching
physical therapy in warm pool performing Ai Chi
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital Universitario "Virgen de las Nieves"
Granada, Granada, 18012, Spain
Calandre EP, Rodriguez-Claro ML, Rico-Villademoros F, Vilchez JS, Hidalgo J, Delgado-Rodriguez A. Effects of pool-based exercise in fibromyalgia symptomatology and sleep quality: a prospective randomised comparison between stretching and Ai Chi. Clin Exp Rheumatol. 2009 Sep-Oct;27(5 Suppl 56):S21-8.
Elena P. Calandre
Professor of Clinical Pharmacology
Mª Luz Rodriguez-Claro
physiotherapist
90 participants (actual enrollment reported by the registry).
First Submitted
October 26, 2007
First Posted
October 30, 2007
Study Start
March 2006
Date type not reportedThis date has not been verified as actual or estimated.
Discomfort and Psychosocial Difficulties in Fibromyalgia
A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia
Contact the study team to confirm eligibility.
Study Completion
December 2006
Actual (reported)Last Updated
April 6, 2010
Record last verified: 2007-09
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Source: ClinicalTrials.gov.
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