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Ai Chi Versus Stretching in Fibromyalgia Management

This study has been completed.
Sponsor:
Information provided by:
Universidad de Granada
ClinicalTrials.gov Identifier:
NCT00600574
First received: January 14, 2008
Last updated: July 7, 2008
Last verified: July 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • Fibromialgya Impact Questionnaire [ Time Frame: baseline, 6 months, 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pittsbugh Sleep Quality Index [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • SF-36 Health Survey [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Brief Pain Inventory [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Adverse reaction recording [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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, Universidad de Granada
ClinicalTrials.gov Identifier: NCT00600574     History of Changes
Other Study ID Numbers: ML-2007
Study First Received: January 14, 2008
Last Updated: July 7, 2008
Health Authority: Spain: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on May 19, 2013