Pool-based Exercise in Fibromyalgia Management

NCT00550641 | Completed Phase 4

• 1 other identifier: ML-2006
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

fibromyalgia; pool-based exercise

Outcome Measures

Primary Outcomes (1)

• Improvement in fibromyalgia symptomatology

  18 weeks

Secondary Outcomes (1)

• Improvement in sleep, depressive and anxiety symptomatology and quality of life

  18 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Other: physical therapy

2

EXPERIMENTAL

Other: physical therapy

Interventions

physical therapy OTHER

physical therapy in warm pool performing stretching

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Hospital Universitario "Virgen de las Nieves"

Granada, Granada, 18012, Spain

Location

Related 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 Rheumatol. 2009 Sep-Oct;27(5 Suppl 56):S21-8.

  PMID: 20074435 RESULT

MeSH Terms

Conditions

Fibromyalgia

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Elena P. Calandre

  Professor of Clinical Pharmacology

  STUDY DIRECTOR

• Mª Luz Rodriguez-Claro

  physiotherapist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 26, 2007
• First Posted: October 30, 2007
• Study Start: March 1, 2006
• Study Completion: December 1, 2006
• Last Updated: April 6, 2010

Record last verified: 2007-09

Locations

ES (1)