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Pool-based Exercise in Fibromyalgia Management

NCT00550641 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2010-04-06

No results posted yet for this study

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

Interventions

OTHER

physical therapy

physical therapy in warm pool performing stretching

OTHER

physical therapy

physical therapy in warm pool performing Ai Chi

Sponsors & Collaborators

  • Universidad de Granada

    lead OTHER

Principal Investigators

  • Elena P. Calandre · Professor of Clinical Pharmacology

  • Mª Luz Rodriguez-Claro · physiotherapist

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Completion
2006-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00550641 on ClinicalTrials.gov