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OpenTrials
Completed

NCT Number: NCT00550641

Pool-based Exercise in Fibromyalgia Management

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario "Virgen de las Nieves"

Granada, 18012, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Therapy

Other

physical therapy in warm pool performing stretching

Primary outcomes

  1. Improvement in fibromyalgia symptomatology

    Time frame: 18 weeks

Secondary outcomes

  1. Improvement in sleep, depressive and anxiety symptomatology and quality of life

    Time frame: 18 weeks

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2006
First posted
Oct 30, 2007
Registry last updated
Apr 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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