search
Back to results

Ai Chi Versus Stretching in Fibromyalgia Management

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
physical therapy
physical therapy
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, physical therapies, stretching, Ai Chi

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario "Virgen de las Nieves"

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

S

AI

Arm Description

physiotherapy in warm pool by means of stretching

physiotherapy in warm pool by means of Ai Chi

Outcomes

Primary Outcome Measures

Fibromialgya Impact Questionnaire

Secondary Outcome Measures

Pittsbugh Sleep Quality Index
Hospital Anxiety and Depression Scale
SF-36 Health Survey
Brief Pain Inventory
Adverse reaction recording

Full Information

First Posted
January 14, 2008
Last Updated
December 1, 2014
Sponsor
Universidad de Granada
search

1. Study Identification

Unique Protocol Identification Number
NCT00600574
Brief Title
Ai Chi Versus Stretching in Fibromyalgia Management
Official Title
A Randomized Controlled Trial Comparing the Efficay and Tolerability of Ai Chi Versus Stretching in Fibromyalgia Management: a Six Months Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, physical therapies, stretching, Ai Chi

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S
Arm Type
Active Comparator
Arm Description
physiotherapy in warm pool by means of stretching
Arm Title
AI
Arm Type
Experimental
Arm Description
physiotherapy in warm pool by means of Ai Chi
Intervention Type
Other
Intervention Name(s)
physical therapy
Other Intervention Name(s)
physiotherapy
Intervention Description
weekly pool physiotherapy with muscle stretching
Intervention Type
Other
Intervention Name(s)
physical therapy
Other Intervention Name(s)
physiotherapy
Intervention Description
weekly pool physiotherapy with Ai Chi movements during a 6 months period
Primary Outcome Measure Information:
Title
Fibromialgya Impact Questionnaire
Time Frame
baseline, 6 months, 1 year
Secondary Outcome Measure Information:
Title
Pittsbugh Sleep Quality Index
Time Frame
baseline, 6 months, 12 months
Title
Hospital Anxiety and Depression Scale
Time Frame
baseline, 6 months, 12 months
Title
SF-36 Health Survey
Time Frame
baseline, 6 months, 12 months
Title
Brief Pain Inventory
Time Frame
baseline, 6 months, 12 months
Title
Adverse reaction recording
Time Frame
baseline, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena P. Calandre, M.D.
Organizational Affiliation
Universidad de Granada
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario "Virgen de las Nieves"
City
Granada
ZIP/Postal Code
18014
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
17278933
Citation
Gowans SE, deHueck A. Pool exercise for individuals with fibromyalgia. Curr Opin Rheumatol. 2007 Mar;19(2):168-73. doi: 10.1097/BOR.0b013e3280327944.
Results Reference
background

Learn more about this trial

Ai Chi Versus Stretching in Fibromyalgia Management

We'll reach out to this number within 24 hrs