Ai Chi Versus Stretching in Fibromyalgia Management

December 1, 2014 updated by: Elena Pita Calandre, Universidad de Granada

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

94

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18014
        • Hospital Universitario "Virgen de las Nieves"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: S
physiotherapy in warm pool by means of stretching
Other: physical therapy
weekly pool physiotherapy with muscle stretching
Other Names:
  • physiotherapy
Other: physical therapy
weekly pool physiotherapy with Ai Chi movements during a 6 months period
Other Names:
  • physiotherapy
Experimental: AI
physiotherapy in warm pool by means of Ai Chi
Other: physical therapy
weekly pool physiotherapy with muscle stretching
Other Names:
  • physiotherapy
Other: physical therapy
weekly pool physiotherapy with Ai Chi movements during a 6 months period
Other Names:
  • physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fibromialgya Impact Questionnaire
Time Frame: baseline, 6 months, 1 year
baseline, 6 months, 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Granada

Investigators

  • Study Director: Elena P. Calandre, M.D., Universidad de Granada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

January 14, 2008

First Submitted That Met QC Criteria

January 14, 2008

First Posted (Estimate)

January 25, 2008

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML-2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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