Effectiveness of Tai Chi on Cardiac Autonomic Function and Symptomatology in Women With Fibromyalgia: a Randomized Controlled Trial
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tai Chi Training
Sponsored by
About this trial
This is an interventional health services research trial for Fibromyalgia
Eligibility Criteria
Inclusion Criteria:
- Fibromyalgia
- Sedentary
Exclusion Criteria:
- Known pulmonary, cardiovascular, renal, adrenal, pituitary, severe psychiatric or thyroid diseases.
- Use of hormone replacement therapy during the 6 months prior to the study.
- Any medication changes in the previous 12 months.
- Current participation in psychological or physical therapy
- History of steady exercise or received exercise training in the last year
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Tai Chi Training
Control
Arm Description
Tai Chi exercises 3 times per wk for 12 weeks
This arm involves not making any change to the subject's lifestyle at the moment of the start of the intervention and for 12 weeks.
Outcomes
Primary Outcome Measures
Autonomic Function
Heart Rate Variability was assessed from electrocardiogram
Secondary Outcome Measures
Fibromyalgia Symptomatology
Subjects filled visual analog scales (VAS) to evaluate symptom severity before and after 12 weeks.
Flexibilty
Flexibility was measured using the Sit and Reach Test
Muscle Strength
one repetition maximum (1RM) was performed using a leg extension machine
Full Information
NCT ID
NCT03016585
First Posted
January 8, 2017
Last Updated
October 30, 2020
Sponsor
Pusan National University
Collaborators
Marymount University
1. Study Identification
Unique Protocol Identification Number
NCT03016585
Brief Title
Effectiveness of Tai Chi on Cardiac Autonomic Function and Symptomatology in Women With Fibromyalgia: a Randomized Controlled Trial
Official Title
Effectiveness of Tai Chi on Cardiac Autonomic Function and Symptomatology in Women With Fibromyalgia: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University
Collaborators
Marymount University
4. Oversight
5. Study Description
Brief Summary
Fibromyalgia (FM) is an idiopathic disease affecting approximately 3% of the world population, primarily diagnosed in middle-aged women. Although FM is mainly characterized by chronic pain and fatigue, reduced muscular strength and flexibility are common symptoms associated with the presentation of the disorder. Interestingly, the etiology and underlying mechanism of FM are not completely understood, but previous findings suggest that autonomic dysfunction may explain some of the FM symptoms.
Compared to age-matched healthy individuals, patients with FM have an attenuated autonomic function which is associated with a reduction in vagal tone and increase in sympathetic activity. Therefore, autonomic function is a worthwhile target intervention in individuals with FM. Although traditional exercise ( both aerobic and resistance) has been shown to effectively improve HRV parameters and FM symptoms, most FM patients display a decline in adherence to traditional exercise and continue to experience considerable pain and fatigue years after the original diagnosis ultimately requiring medication to control their symptoms.Thus, new approaches are needed to improve autonomic function and clinical symptoms in patients with FM, which will ultimately improve their physical and emotional functioning leading to a better quality of life.
Tai Chi (TC) is a form of ancient Chinese martial art which integrates slow movements, controlled breathing and mental concentration. TC training is safe for special populations and has previously shown to decrease pain, fatigue as well as other FM related symptoms.However, the potential role of TC training on autonomic function is largely unexplored.
The investigators hypothesis is that 12 weeks of TC training would improve our primary outcome of autonomic function through improvements in sympathovagal balance, and the secondary outcomes measures of FM symptoms (pain, fatigue and sleep quality), strength and flexibility.
Detailed Description
The purpose of this study is to examine the effects of 12 weeks of TC training on on cardiac autonomic function, FM symptoms (pain, fatigue and sleep quality), strength and flexibility. The specific aim of the study is:
- To evaluate the effects of 12 weeks of TC training on autonomic function arterial function by assessing heart rate variability
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
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tai Chi Training
Arm Type
Experimental
Arm Description
Tai Chi exercises 3 times per wk for 12 weeks
Arm Title
Control
Arm Type
No Intervention
Arm Description
This arm involves not making any change to the subject's lifestyle at the moment of the start of the intervention and for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Tai Chi Training
Intervention Description
Participants practiced, under supervised instruction, 10 forms from the classic Yang style of Tai Chi 3 times per wk for 12 weeks.The Tai Chi sessions lasted approximately 55 minutes and included a 10-minute warm up, 40 minutes of practice and exercise finalizing with a 5-minute cooldown period.
Primary Outcome Measure Information:
Title
Autonomic Function
Description
Heart Rate Variability was assessed from electrocardiogram
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Fibromyalgia Symptomatology
Description
Subjects filled visual analog scales (VAS) to evaluate symptom severity before and after 12 weeks.
Time Frame
12 weeks
Title
Flexibilty
Description
Flexibility was measured using the Sit and Reach Test
Time Frame
12 weeks
Title
Muscle Strength
Description
one repetition maximum (1RM) was performed using a leg extension machine
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fibromyalgia
Sedentary
Exclusion Criteria:
Known pulmonary, cardiovascular, renal, adrenal, pituitary, severe psychiatric or thyroid diseases.
Use of hormone replacement therapy during the 6 months prior to the study.
Any medication changes in the previous 12 months.
Current participation in psychological or physical therapy
History of steady exercise or received exercise training in the last year
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Tai Chi on Cardiac Autonomic Function and Symptomatology in Women With Fibromyalgia: a Randomized Controlled Trial
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