Ignite Creation Date:
2024-05-06 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03016585
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2017-01-08
Brief Title:
Effectiveness of Tai Chi on Cardiac Autonomic Function and Symptomatology in Women With Fibromyalgia a Randomized Controlled Trial
Sponsor:
Pusan National University
Organization:
Pusan National University
Study Overview
Official Title:
Effectiveness of Tai Chi on Cardiac Autonomic Function and Symptomatology in Women With Fibromyalgia a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 symptomsThus 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 symptomsHowever 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
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 symptomsThus 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 symptomsHowever 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
- To evaluate the effects of 12 weeks of TC training on autonomic function arterial function by assessing heart rate variability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None