An interventional study of Mind-body exercise and Light mobility exercises in Fibromyalgia, sponsored by University of Kansas Medical Center. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-04.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment
The purpose of this study is to compare two different exercise programs to see if there are differences after exercise in fibromyalgia (FM) symptoms and responses from the immune system.
Inclusion Criteria for FM Patients:
Exclusion Criteria for all Participants:
Inclusion Criteria for Healthy Controls:
Exclusion Criteria for Healthy Controls:
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.
Other: Mind-body exercise
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.
Other: Light mobility exercises
Healthy females will be asked to make one visit to complete aerobic exercise test, questionnaires, and provide blood samples.
Exercise program.
Modified mind-body program.
Change in anti-inflammatory cytokine (IL-6, IL-8, and IL-10)
Changes will be measured during a bout of exhaustive exercise using a recumbent bicycle machine
Time frame: At three time points: before exercise, at the maximum exertion, and 30 minutes after maximum exertion. This procedure will be conducted at baseline and after 8 weeks of qigong/sham-qigong practice.
Change in Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSIQ), which was designed to differentiate between good and poor sleepers. The PSIQ covers subjective sleep quality, sleep latency, sleep disturbances, sleep duration, daytime dysfunction and use of sleep medications. It consists of 19 self-rated questions. The PSIQ has been vastly employed in clinical trials, and it has been reported to be reliable and valid
Time frame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
Change in Pressure Pain Threshold (PPT)
Pressure pain threshold is defined as the minimum force applied which induces pain. Mechanical pressure, determined as a kilogram (kg) per 1 cm2 of skin on the sensitive areas, is applied by a Fisher's hand dolorimeter. The examiner places the rubber tip on the examination site and gradually increases the pressure at a rate of approximately 1 kg per second. Subjects are instructed to say ''yes'' when the sensation of pressure causes pain and the pain pressure threshold is recorded. Pain threshold is measured in the 18 points specified by the American College of Rheumatology.
Time frame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
Change in Fibromyalgia Impact Questionnaire (FIQR)
This questionnaire can capture the total spectrum of issues related to FM and the patient's response to therapies. It is one of the most used instrument in trials involving subjects with FM. Also, it has been proven to show consistent response to clinical changes
Time frame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
Change in Quality of Life evaluated by the Quality of Life Scale (QOLS)
This scale is one of the most used instrument to measure quality of life in patients with chronic disease. The QOLS is a 15-item questionnaire that accesses five conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, and recreation. This scale has been shown to be reliable and validated by previous studies
Time frame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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University of Kansas Medical Center