FibromyalgiaNCT03016585
Effectiveness of Tai Chi on Cardiac Autonomic Function and Symptomatology in Women With Fibromyalgia: a Randomized Controlled Trial
A study testing Tai Chi Training in people with Fibromyalgia, run by Pusan National University.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Tai Chi Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fibromyalgia
- Sedentary
Who cannot join
- 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
About this study
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.
Read more
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
- Conditions
- Fibromyalgia
- Being tested
- Tai Chi Training
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi Training | Experimental | Tai Chi exercises 3 times per wk for 12 weeks Receives: Other: Tai Chi Training |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Autonomic Function
Heart Rate Variability was assessed from electrocardiogram
Measured: 12 weeks
Secondary outcomes (3)
Fibromyalgia Symptomatology
Subjects filled visual analog scales (VAS) to evaluate symptom severity before and after 12 weeks.
Measured: 12 weeks
Flexibilty
Flexibility was measured using the Sit and Reach Test
Measured: 12 weeks
Muscle Strength
one repetition maximum (1RM) was performed using a leg extension machine
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University
- Sponsor type
- University, hospital or other
- Collaborators
- Marymount University
- Responsible party
- Principal investigator, Won-mok son, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016585
- Sponsor's protocol ID
- PusanNU
- Status last verified
- Oct 2020
- First submitted
- 8 Jan 2017
- Last updated
- 3 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tai Chi on Cardiac Autonomic Function and Symptomatology in Women With Fibromyalgia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03016585
- Acronym / sponsor ID
- PusanNU
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Pusan National UniversityUniversity, hospital or other
- Collaborators
- Marymount University
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi Training | Experimental | Other: Tai Chi TrainingTai Chi exercises 3 times per wk for 12 weeks |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fibromyalgia
- Sedentary
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi TrainingParticipants 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. | Other | Tai Chi Training |
Primary outcome
Autonomic Function
Time frame: 12 weeks
Heart Rate Variability was assessed from electrocardiogram
3 secondary outcomes
Fibromyalgia Symptomatology
Time frame: 12 weeks
Flexibilty
Time frame: 12 weeks
Muscle Strength
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi Training in people with Fibromyalgia, run by Pusan National University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomic Function (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.