Ai Chi Versus Stretching in Fibromyalgia Management

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: physical therapy
* Other: physical therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: S<br>physiotherapy in warm pool by means of stretching | Other: physical therapy<br>* weekly pool physiotherapy with muscle stretching<br>* Other names: physiotherapy;|
| Experimental: AI<br>physiotherapy in warm pool by means of Ai Chi | Other: physical therapy<br>* weekly pool physiotherapy with Ai Chi movements during a 6 months period<br>* Other names: physiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromialgya Impact Questionnaire |  | baseline, 6 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsbugh Sleep Quality Index |  | baseline, 6 months, 12 months | 
| Hospital Anxiety and Depression Scale |  | baseline, 6 months, 12 months | 
| SF-36 Health Survey |  | baseline, 6 months, 12 months | 
| Brief Pain Inventory |  | baseline, 6 months, 12 months | 
| Adverse reaction recording |  | baseline, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibromyalgia, physical therapies, stretching, Ai Chi