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Clinical Trials/NCT00600574
NCT00600574
Completed
Phase 4

A Randomized Controlled Trial Comparing the Efficay and Tolerability of Ai Chi Versus Stretching in Fibromyalgia Management: a Six Months Study

Universidad de Granada1 site in 1 country94 target enrollmentJanuary 2007
ConditionsFibromyalgia

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Universidad de Granada
Enrollment
94
Locations
1
Primary Endpoint
Fibromialgya Impact Questionnaire
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The purpose of the study is to compare the efficacy and tolerability of Ai Chi, an adaptation of Tai Chi exercise to water, with stretching on fibromyalgia symtomatology.

Detailed Description

Physical therapies have shown to be effective in the treatment of fibromyalgia and It is generally assumed that a multidisciplinary approach, combining both pharmacologic and non-pharmacologic measures, is probably the optimal treatment approach for most fibromyalgia patients. As these patients are usually physically deconditioned, low-intensity exercise has been recommended at least as initial treatment. At this respect, exercise in warm water is considered a good option as both temperature and water buoyancy minimize body weight's stress and help patients to minimize pain. In a previous study comparing short term physiotherapy with stretching and Ai Chi we found that Ai Chi was at least as effective as stretching and induced a significant reduction in fibromyalgia core symptomatology and in sleep parameters. The objective of the present randomized controlled study is to compare both physiotherapy techniques in a long term basis.

Registry
clinicaltrials.gov
Start Date
January 2007
End Date
February 2008
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elena Pita Calandre

Professor of Pharmacology

Universidad de Granada

Eligibility 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

Outcomes

Primary Outcomes

Fibromialgya Impact Questionnaire

Time Frame: baseline, 6 months, 1 year

Secondary Outcomes

  • Brief Pain Inventory(baseline, 6 months, 12 months)
  • SF-36 Health Survey(baseline, 6 months, 12 months)
  • Pittsbugh Sleep Quality Index(baseline, 6 months, 12 months)
  • Hospital Anxiety and Depression Scale(baseline, 6 months, 12 months)
  • Adverse reaction recording(baseline, 6 months, 12 months)

Study Sites (1)

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