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CompletedNCT03016585Updated Nov 3, 2020

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

An interventional study of Tai Chi Training in Fibromyalgia, sponsored by Pusan National University. Completed. Open to female participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-11-03.

Sponsored by Pusan National University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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
02

Conditions studied

03

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Fibromyalgia
  • Sedentary

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    Tai Chi Training

    Tai Chi exercises 3 times per wk for 12 weeks

    Other: Tai Chi Training

  • 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.

Interventions

  • OtherTai 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.

05

What researchers measure

Primary outcomes

  1. Autonomic Function

    Heart Rate Variability was assessed from electrocardiogram

    Time frame: 12 weeks

Secondary outcomes

  1. Fibromyalgia Symptomatology

    Subjects filled visual analog scales (VAS) to evaluate symptom severity before and after 12 weeks.

    Time frame: 12 weeks

  2. Flexibilty

    Flexibility was measured using the Sit and Reach Test

    Time frame: 12 weeks

  3. Muscle Strength

    one repetition maximum (1RM) was performed using a leg extension machine

    Time frame: 12 weeks

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03016585
Lead sponsor
Pusan National University
Collaborators
Marymount University
Responsible party
Won-mok son (Ph.D, Pusan National University) — Principal investigator
First posted
Jan 10, 2017
Start date
Jan 2016
Primary completion
May 2016
Completion
May 2016
Last update
Nov 3, 2020
View the source record on ClinicalTrials.gov ↗

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