Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Quantitative Sensory Test (QST), and
研究概览
简要总结
This study aims to evaluate the effect of therapeutic exercise on the gut microbiome in chronic widespread pain patients. Our investigation purpose is to improve the quality of life of participants, reduce their disability and optimize their functionality.
The intervention will last 6 weeks, with 2 face-to-face therapeutic exercise sessions guided by a professional and a 6-week post-intervention follow-up.
The participation will require:
- Attend the 12 therapeutic exercise sessions
- Attend the 3 evaluations: at the beginning (A0), post intervention (A1) and +6 weeks after finishing the exercise program (A3).
The items to be evaluated will be the following:
- The Ronald Morris Disability Questionnaire (RMDQ)
- Anxiety (State-Trait Anxiety Inventory (STAI))
- Depression: Beck Depression Inventory (BDI)
- Quality of Life: SF-12
- Pain: numerical scale (0-100) and The Brief Pain Inventory (BPI)
- Sensory tests: heat pain threshold (HPT), pressure pain threshold (PPT) and pain modulation (CPM)
- Perform a pre blood test on interleukins IL-18 and IL-1β
This study involves the processing of personal data, so the researchers will guarantee confidentiality in their treatment at all times, complying with the personal data protection regulations, in particular, European Regulation 679/2016. , of April 27, general data protection, as well as Organic Law 3/2018, of December 5, Protection of Personal Data and Guarantee of Digital Rights.
In order to maintain your privacy and anonymity during the research, only one person on the research team will know how names were assigned to a participation number.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be at least 18 years old
- •Must be diagnosed with: osteoarthritis, osteoarthritis, Sudeck or fibromyalgia.
排除标准
- •Suffering or having suffered from cancer, psychiatric disorders, or another ongoing major illness (irritable bowel syndrome, hepatitis, Lyme disease or diabetes).
- •Patients will be excluded if they have more than 6 points on the Beck Depression Inventory, more than 30 points on the "State Trait Anxiety Inventory" or suffer from dementia.
结局指标
主要结局
Quantitative Sensory Test (QST), and
时间窗: From enrollment to the end of the intervention at 6 weeks
Conditioned Pain Modulation (CPM) and pain threshold will be assesed as measured of QST.
Psychological and PainTest
时间窗: From enrollment to the end of the intervention at 6 weeks
Furthermore,Beck Depression Inventory and State-Trait Anxiety Inventory (STAI) will be perform as a psychological test. The Brief Pain Inventory (BPI) and a numerical rate scale will be perform as a pain tests.
Descriptive parameters
时间窗: From enrollment to the end of the intervention at 6 weeks
Descriptive parameters of the sample will be explain in a table
次要结局
- Interleukin analysis(From enrollment to the end of the intervention at 6 weeks)
研究者
María Elena González Álvarez
Principal Investigator
Universidad Rey Juan Carlos