Pool-based Exercise in Fibromyalgia Management

NCT ID: NCT00550641

Last Updated: 2010-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2006-12-31

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).

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

physical therapy

Intervention Type: OTHER

physical therapy in warm pool performing stretching

2

Group Type: EXPERIMENTAL

physical therapy

Intervention Type: OTHER

physical therapy in warm pool performing Ai Chi

Interventions

physical therapy

physical therapy in warm pool performing stretching

Intervention Type: OTHER

physical therapy

physical therapy in warm pool performing Ai Chi

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Granada

OTHER

Sponsor Role: lead

Principal Investigators

Elena P. Calandre

Role: STUDY_DIRECTOR

Professor of Clinical Pharmacology

Mª Luz Rodriguez-Claro

Role: PRINCIPAL_INVESTIGATOR

physiotherapist

Locations

Hospital Universitario "Virgen de las Nieves"

Granada, Granada, Spain

Countries

Spain

References

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.

Reference Type: RESULT

PMID: 20074435 (View on PubMed)

Other Identifiers

ML-2006

Identifier Type: -

Identifier Source: org_study_id