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Ai Chi Versus Stretching in Fibromyalgia Management

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.
ClinicalTrials.gov Identifier: NCT00600574
Recruitment Status : Completed
First Posted : January 25, 2008
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Elena Pita Calandre, Universidad de Granada

Tracking Information
First Submitted Date  ICMJE January 14, 2008
First Posted Date  ICMJE January 25, 2008
Last Update Posted Date December 3, 2014
Study Start Date  ICMJE January 2007
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2008)
Fibromialgya Impact Questionnaire [ Time Frame: baseline, 6 months, 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00600574 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Ai Chi Versus Stretching in Fibromyalgia Management
Official Title  ICMJE A Randomized Controlled Trial Comparing the Efficay and Tolerability of Ai Chi Versus Stretching in Fibromyalgia Management: a Six Months Study
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.
Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Other: physical therapy
    weekly pool physiotherapy with muscle stretching
    Other Name: physiotherapy
  • Other: physical therapy
    weekly pool physiotherapy with Ai Chi movements during a 6 months period
    Other Name: physiotherapy
Study Arms
  • Active Comparator: S
    physiotherapy in warm pool by means of stretching
    Intervention: Other: physical therapy
  • Experimental: AI
    physiotherapy in warm pool by means of Ai Chi
    Intervention: Other: physical therapy
Publications * Gowans SE, deHueck A. Pool exercise for individuals with fibromyalgia. Curr Opin Rheumatol. 2007 Mar;19(2):168-73. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2008)
94
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00600574
Other Study ID Numbers  ICMJE ML-2007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Elena Pita Calandre, Universidad de Granada
Study Sponsor  ICMJE Universidad de Granada
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Elena P. Calandre, M.D. Universidad de Granada
PRS Account Universidad de Granada
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP