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Ai Chi Versus Stretching in Fibromyalgia Management

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00600574
First Posted: January 25, 2008
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Elena Pita Calandre, Universidad de Granada
  Purpose
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.

Condition Intervention Phase
Fibromyalgia Other: physical therapy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing the Efficay and Tolerability of Ai Chi Versus Stretching in Fibromyalgia Management: a Six Months Study

Resource links provided by NLM:


Further study details as provided by Elena Pita Calandre, Universidad de Granada:

Primary Outcome Measures:
  • Fibromialgya Impact Questionnaire [ Time Frame: baseline, 6 months, 1 year ]

Secondary Outcome Measures:
  • Pittsbugh Sleep Quality Index [ Time Frame: baseline, 6 months, 12 months ]
  • Hospital Anxiety and Depression Scale [ Time Frame: baseline, 6 months, 12 months ]
  • SF-36 Health Survey [ Time Frame: baseline, 6 months, 12 months ]
  • Brief Pain Inventory [ Time Frame: baseline, 6 months, 12 months ]
  • Adverse reaction recording [ Time Frame: baseline, 6 months, 12 months ]

Enrollment: 94
Study Start Date: January 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: S
physiotherapy in warm pool by means of stretching
Other: physical therapy
weekly pool physiotherapy with muscle stretching
Other Name: physiotherapy
Experimental: AI
physiotherapy in warm pool by means of Ai Chi
Other: physical therapy
weekly pool physiotherapy with Ai Chi movements during a 6 months period
Other Name: physiotherapy

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600574


Locations
Spain
Hospital Universitario "Virgen de las Nieves"
Granada, Spain, 18014
Sponsors and Collaborators
Universidad de Granada
Investigators
Study Director: Elena P. Calandre, M.D. Universidad de Granada
  More Information

Publications:
Responsible Party: Elena Pita Calandre, Professor of Pharmacology, Universidad de Granada
ClinicalTrials.gov Identifier: NCT00600574     History of Changes
Other Study ID Numbers: ML-2007
First Submitted: January 14, 2008
First Posted: January 25, 2008
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Elena Pita Calandre, Universidad de Granada:
fibromyalgia
physical therapies
stretching
Ai Chi

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases