Back to resultsThe Effect of Tai Chi in Treating Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Taichi
Dance
Sponsored by
About this trial
This is an interventional supportive care trial for Fibromyalgia
Eligibility Criteria
Inclusion Criteria:
- 40 years of age or older
- meeting the classification of FM per the 1990 ACR criteria
- approval by a healthcare provider for participation
Exclusion Criteria:
- had practiced Tai chi within the past 6 months
- had exercised >30 min three times weekly for past 3 months
- could not independently ambulate without assistive devices
- had BPI pain severity or interference scores less than 5
- had planned elective surgery during study period
- were actively involved in health-related litigation
- were unwilling to keep all treatments/medications steady throughout the study period
Sites / Locations
- General Hospital of Chengdu Military Area Command PLA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Taichi
Control
Arm Description
patients exercise with Tai chi
patients under exercise of dance
Outcomes
Primary Outcome Measures
Fibromyalgia Impact Questionnaire (FIQ)
Secondary Outcome Measures
Full Information
NCT ID
NCT02257034
First Posted
October 2, 2014
Last Updated
March 31, 2017
Sponsor
Chengdu PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02257034
Brief Title
The Effect of Tai Chi in Treating Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chengdu PLA General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the effect of Tai chi on Fibromyalgia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Taichi
Arm Type
Experimental
Arm Description
patients exercise with Tai chi
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
patients under exercise of dance
Intervention Type
Other
Intervention Name(s)
Taichi
Intervention Type
Other
Intervention Name(s)
Dance
Primary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire (FIQ)
Time Frame
up to 48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
40 years of age or older
meeting the classification of FM per the 1990 ACR criteria
approval by a healthcare provider for participation
Exclusion Criteria:
had practiced Tai chi within the past 6 months
had exercised >30 min three times weekly for past 3 months
could not independently ambulate without assistive devices
had BPI pain severity or interference scores less than 5
had planned elective surgery during study period
were actively involved in health-related litigation
were unwilling to keep all treatments/medications steady throughout the study period
Facility Information:
Facility Name
General Hospital of Chengdu Military Area Command PLA
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610083
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Effect of Tai Chi in Treating Fibromyalgia
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