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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full mind-body exercises | Experimental | 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. |
|
| Light mobility exercises: Control Group | Active Comparator | 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. |
|
| Healthy Controls | No Intervention | Healthy females will be asked to make one visit to complete aerobic exercise test, questionnaires, and provide blood samples. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind-body exercise | Other | Exercise program. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria for FM Patients:
Exclusion Criteria for all Participants:
Inclusion Criteria for Healthy Controls:
Exclusion Criteria for Healthy Controls:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caio Sarmento, PT | Contact | (913) 588-4565 | cmessiassarmento@kumc.edu | |
| Taylor Pfeifer | Contact | (913) 588-4565 | t009p412@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Wen Liu, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32455108 | Derived | 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. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D009043 | Motor Activity |
| D010146 | Pain |
| D005221 | Fatigue |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Light mobility exercises |
| Other |
Modified mind-body program. |
|
| 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. | 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 | 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 | At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention |
| D009422 |
| Nervous System Diseases |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |