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CompletedNCT00550641Updated Apr 6, 2010

Pool-based Exercise in Fibromyalgia Management

A Phase 4 interventional study of physical therapy and physical therapy in Fibromyalgia, sponsored by Universidad de Granada. Completed at 1 site in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-04-06.

Sponsored by Universidad de Granada · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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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).

02

Conditions studied

  • Fibromyalgia

Keywords

  • fibromyalgia
  • pool-based exercise
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In context

Fibromyalgia

1,335 studies on the registry are indexed under Fibromyalgia; 265 are open to participants now.

This study's enrollment of 90 is above the median of 60 across 1,034 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Universidad de Granada is the lead sponsor of 241 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    1

    Other: physical therapy

  • Experimental
    2

    Other: physical therapy

Interventions

  • Otherphysical therapy

    physical therapy in warm pool performing stretching

  • Otherphysical therapy

    physical therapy in warm pool performing Ai Chi

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What researchers measure

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

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Study locations

1 site
  • Hospital Universitario "Virgen de las Nieves"
    Granada, 18012, Spain
08

References and documents

Publications

  • 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. PubMed 20074435 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00550641
Lead sponsor
Universidad de Granada
First posted
Oct 30, 2007
Start date
Mar 2006
Completion
Dec 2006
Last update
Apr 6, 2010

Study contacts

Elena P. Calandre
study director · Professor of Clinical Pharmacology
Mª Luz Rodriguez-Claro
principal investigator · physiotherapist

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.

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