The Altered Immune Response to Exercise in Patients With Fibromyalgia Before and After a Mind-body Intervention
NCT ID: NCT03441997
Last Updated: 2019-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2018-02-01
2019-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Full mind-body exercises
Participants will be trained to perform a type of mind-body exercise that involves low intensity exercise and body movements similar to Tai Chi. Participants will be asked to exercise 2 times per day for 8 weeks.
Mind-body exercise
Exercise program.
Light mobility exercises: Control Group
The Light mobility exercises group will perform a similar exercise as the experimental group. However without a few components. Participants will be asked to exercise two times per day for 8 weeks.
Light mobility exercises
Modified mind-body program.
Healthy Controls
Healthy females will be asked to make one visit to complete aerobic exercise test, questionnaires, and provide blood samples.
No interventions assigned to this group
Interventions
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Mind-body exercise
Exercise program.
Light mobility exercises
Modified mind-body program.
Eligibility Criteria
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Inclusion Criteria
* Clearance from patient's physician to participate in a clinical trial
* Not participating or willing to discontinue FM treatment with trans-cutaneous electrical nerve stimulation, biofeedback, tender-point injections, acupuncture, Yoga, and Tai Chi.
* Female
* No apparent medical condition that will interfere with participation in the study
* Not on any medication that will interfere with participation in this study
Exclusion Criteria
* Abuse of alcohol, benzodiazepines, or other drugs
* Active cardiovascular, pulmonary, hepatic, renal, gastrointestinal, or autoimmune disease (except Hashimoto's or Graves' disease that has been stable for 3 months before screening)
* Current systemic infection
* Active cancer (except basal cell carcinoma);
* Unstable endocrine disease
* Severe sleep apnea
* Prostate enlargement or other genitourinary disorder (male patients)
* Pregnancy or breastfeeding
* Medical or surgical conditions including medication that preclude participation in the study
* Presence of motor or neuromuscular deficits that may preclude participating in fatigue exercise
18 Years
70 Years
FEMALE
Yes
Sponsors
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University of Kansas Medical Center
OTHER
Responsible Party
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Principal Investigators
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Wen Liu, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Sarmento CVM, Moon S, Pfeifer T, Smirnova IV, Colgrove Y, Lai SM, Liu W. The therapeutic efficacy of Qigong exercise on the main symptoms of fibromyalgia: A pilot randomized clinical trial. Integr Med Res. 2020 Dec;9(4):100416. doi: 10.1016/j.imr.2020.100416. Epub 2020 Apr 25.
Other Identifiers
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STUDY00141263
Identifier Type: -
Identifier Source: org_study_id
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