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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Tai Chi Training

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

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tai Chi Training; Tai Chi exercises 3 times per wk for 12 weeks	Other: Tai Chi Training; 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.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autonomic Function	Heart Rate Variability was assessed from electrocardiogram	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fibromyalgia Symptomatology	Subjects filled visual analog scales (VAS) to evaluate symptom severity before and after 12 weeks.	12 weeks
Flexibilty	Flexibility was measured using the Sit and Reach Test	12 weeks
Muscle Strength	one repetition maximum (1RM) was performed using a leg extension machine	12 weeks

Collaborators and Investigators

• Sponsor: Pusan National University
• Collaborators: Marymount University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: January 8, 2017
• First Submitted That Met QC Criteria: January 8, 2017
• First Posted (Estimate): January 10, 2017

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: PusanNU