Pool-based Exercise in Fibromyalgia Management

Phase 4

Completed

• Conditions: Fibromyalgia
• Interventions: Other: physical therapy

• Registration Number: NCT00550641
• Lead Sponsor: Universidad de Granada

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study Completion: 2006-12
• Status Verified: 2007-09
• Study First Submitted: 2007-10-26
• Study First Submitted QC: 2007-10-26
• Study First Posted: 2007-10-30
• Last Update Submitted: 2010-04-05
• Last Update Posted: 2010-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

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Exclusion Criteria

• unable to tolerate warm chlorinated water
• associated medical condition contraindicating exercise in warm water

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	physical therapy	-
2	physical therapy	-

Primary Outcome Measures

Name	Time	Method
Improvement in fibromyalgia symptomatology	18 weeks

Secondary Outcome Measures

Name	Time	Method
Improvement in sleep, depressive and anxiety symptomatology and quality of life	18 weeks

Trial Locations

Locations (1)

Hospital Universitario "Virgen de las Nieves"; 🇪🇸 Granada, Spain