The Altered Immune Response to Exercise in Patients With Fibromyalgia Before and After a Mind-body Intervention
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in anti-inflammatory cytokine (IL-6, IL-8, and IL-10)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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:
- •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 for Healthy Controls:
- •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
研究组 & 干预措施
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.
干预措施: Mind-body exercise (Other)
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.
干预措施: Light mobility exercises (Other)
Healthy Controls
Healthy females will be asked to make one visit to complete aerobic exercise test, questionnaires, and provide blood samples.
结局指标
主要结局
Change in anti-inflammatory cytokine (IL-6, IL-8, and IL-10)
时间窗: 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
次要结局
- Change in Pittsburgh Sleep Quality Index (PSQI)(At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention)
- Change in Pressure Pain Threshold (PPT)(At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention)
- Change in Fibromyalgia Impact Questionnaire (FIQR)(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)(At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention)