Pool-based Exercise in Fibromyalgia Management

Fibromyalgia Clinical Trial

Official title:

Pool-based Exercise in Fibromyalgia Management: a Prospective Randomized Comparison Between Stretching and Ai Chi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00550641
• Other study ID #: ML-2006
• Status: Completed
• Phase: Phase 4
• First received: October 26, 2007
• Last updated: April 5, 2010
• Start date: March 2006
• Est. completion date: December 2006

Study information

• Verified date: September 2007
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• physical therapy
physical therapy in warm pool performing stretching
• physical therapy
physical therapy in warm pool performing Ai Chi

Locations

Country	Name	City	State
Spain	Hospital Universitario "Virgen de las Nieves"	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in fibromyalgia symptomatology		18 weeks
Secondary	Improvement in sleep, depressive and anxiety symptomatology and quality of life		18 weeks