COld Exposure With Controlled BReathing And Meditation in Patients With Multiple Sclerosis (COBRAMS)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- concentration of pro-inflammatory cytokines
研究概览
简要总结
The goal of this interventional study is to test the effect of the anti-inflammatory and neuroprotective effects of this supplementary training program that includes breathing exercises, cold exposure, and meditation in patients diagnosed with multiple sclerosis.
Researchers will compare the effect to control groups of MS patients without intervention.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •RRMS diagnosed according to the official 2020 McDonald's criteria,
- •age 18-55 years,
- •MS duration up to 10 years,
- •EDSS 1.0-5.5,
- •willingness to participate
排除标准
- •relapse or corticosteroid treatment within 3 months prior to study enrollment
- •severe/unstable comorbidity
研究组 & 干预措施
intervention group
干预措施: Wim Hoff method (Combination Product)
control group
结局指标
主要结局
concentration of pro-inflammatory cytokines
时间窗: 12 weeks
blood concentrations in pg/ml of • cytokines (interleukins - IL-1β, IL-6, IL-8, IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33, interferons IFN-α2 and IFN-γ, tumor necrosis factor TNF-α, monocyte chemoattractant protein MCP-1)
concentration of markers of oxidative stress
时间窗: 12 weeks
blood concentration in mmol/l of markers of oxidative stress (OS) - advanced glycation end products (AGEs), fructosamine, advanced oxidation protein products (AOPP), thiobarbituric acid reactive substances (TBARS), total antioxidant capacity (TAC), ferric reducing ability of plasma (FRAP),
concentration of NfL
时间窗: 12 weeks
neurofilamen light chains
concentration of GFAP
时间窗: 12 weeks
glial fibrillary acidic protein
concentration of ecDNA
时间窗: 12 weeks
cell-free extracellular DNA
次要结局
- Symbol Digit Modalities Test(12 weeks)
- General Anxiety Disorder-7(12 weeks)
- Patient Health Questionnaire-9(12 weeks)
- Expanded Disability Status Scale(12 weeks)
- Nine-Hole Peg Test(12 weeks)
- Timed 25-Foot Walk(12 weeks)
- Fatigue Scale for Motor and Cognitive Functions(12 weeks)