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Effectiveness of Tai Chi on Cardiac Autonomic Function and Symptomatology in Women With Fibromyalgia: a Randomized Controlled Trial

P

Pusan National University

Status

Completed

Conditions

Fibromyalgia

Treatments

Other: Tai Chi Training

Study type

Interventional

Funder types

Other

Identifiers

NCT03016585
PusanNU

Details and patient eligibility

About

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.

Full 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

Enrollment

37 patients

Sex

Female

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

37 participants in 2 patient groups

Tai Chi Training
Experimental group
Description:
Tai Chi exercises 3 times per wk for 12 weeks
Treatment:
Other: Tai Chi Training
Control
No Intervention group
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.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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