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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
Pusan National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Fibromyalgia

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

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

    First Posted
    January 8, 2017
    Last Updated
    October 30, 2020
    Sponsor
    Pusan National University
    Collaborators
    Marymount University
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    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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