Pool-Based Exercise in Fibromyalgia Management - Full Text View

Sponsored by:	Universidad de Granada
Information provided by:	Universidad de Granada
ClinicalTrials.gov Identifier:	NCT00550641

Purpose

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	Intervention	Phase
Fibromyalgia	Other: physical therapy	Phase IV

MedlinePlus related topics: Exercise and Physical Fitness Fibromyalgia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Pool-Based Exercise in Fibromyalgia Management: a Prospective Randomized Comparison Between Stretching and Ai Chi

Further study details as provided by Universidad de Granada:

Primary Outcome Measures:

Improvement in fibromyalgia symptomatology [ Time Frame: 18 weeks ]

Secondary Outcome Measures:

Improvement in sleep, depressive and anxiety symptomatology and quality of life [ Time Frame: 18 weeks ]

Enrollment:	90
Study Start Date:	March 2006
Study Completion Date:	December 2006

Arms	Assigned Interventions
1: Active Comparator	Other: physical therapy physical therapy in warm pool performing stretching
2: Experimental	Other: physical therapy physical therapy in warm pool performing Ai Chi

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550641

Locations

Spain
Hospital Universitario "Virgen de las Nieves"
Granada, Spain, 18012

Sponsors and Collaborators

Universidad de Granada

Investigators

Study Director:	Elena P. Calandre	Professor of Clinical Pharmacology
Principal Investigator:	Mª Luz Rodriguez-Claro	physiotherapist

More Information

Study ID Numbers:	ML-2006
Study First Received:	October 26, 2007
Last Updated:	October 26, 2007
ClinicalTrials.gov Identifier:	NCT00550641
Health Authority:	Spain: Ministry of Health

Keywords provided by Universidad de Granada:

fibromyalgia, pool-based exercise

Study placed in the following topic categories:

Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes

Fibromyalgia
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009