Fibromyalgia
Conditions
Keywords
exercise, low intensity exercise, pain, fatigue, sleep problems
Brief summary
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.
Interventions
OTHERMind-body exercise
Exercise program.
OTHERLight mobility exercises
Modified mind-body program.
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
for FM Patients: * Patients with a diagnosis of FM * 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.
Exclusion criteria
for all Participants: * Diagnosis of severe psychiatric illness * 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 Inclusion Criteria for Healthy Controls: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in anti-inflammatory cytokine (IL-6, IL-8, and IL-10) | 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. | Changes will be measured during a bout of exhaustive exercise using a recumbent bicycle machine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pittsburgh Sleep Quality Index (PSQI) | At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention | 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 |
| Change in Pressure Pain Threshold (PPT) | At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention | 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. |
| Change in Fibromyalgia Impact Questionnaire (FIQR) | At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention | 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 |
| Change in Quality of Life evaluated by the Quality of Life Scale (QOLS) | At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention | 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 |
Countries
United States
Contacts
Primary ContactCaio Sarmento, PT
Backup ContactTaylor Pfeifer
Outcome results
None listed