Probiotics in the Management of Pulmonary Rehabilitation for COPD: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- interleukin-6
研究概览
简要总结
This study aims to investigate various aspects of patients with chronic respiratory diseases undergoing pulmonary rehabilitation supplemented with probiotics. The focus will be on clinical physiological responses, functional performance, respiratory status assessments, nutritional status evaluations, body composition analyses, and biochemical blood parameters, with a primary emphasis on the anti-inflammatory response.
详细描述
Background： Patients with chronic obstructive pulmonary disease (COPD) often suffer from malnutrition and weight loss, which negatively impact mortality rates. Research indicates that insufficient intake of fiber, vitamins, and folic acid is associated with airflow limitation in COPD. Malnutrition affects lung function and muscle strength, leading to difficulty in breathing and reduced exercise tolerance. Nutritional support interventions, such as probiotics, are valuable in improving the nutritional status, lung function, and pulmonary rehabilitation in COPD patients.
Study Design： This is a one-year, single-center, prospective randomized controlled trial.
Methods： This study is a randomized controlled trial targeting COPD patients undergoing pulmonary rehabilitation. The plan is to recruit 60 participants, randomly assigned to either the probiotic intervention group or the conventional pulmonary rehabilitation group. The study includes physiological parameters, functional tests, questionnaires, and blood biochemical analyses. Data will be analyzed using SPSS, with statistical significance set at p < 0.05.
Effect： The trial expects that COPD patients receiving probiotic supplementation will achieve significant muscle gain and fat loss, reduce inflammation, and exhibit changes in body composition and functional performance.
Key words： Chronic obstructive pulmonary disease; probiotics; nutritional supplementation; inflammation markers; body composition
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Willing to sign a written informed consent form.
- •Diagnosed with pre-COPD or COPD stage I-IV according to the 2023 GOLD guidelines.
- •Undergoing pulmonary rehabilitation therapy for more than three months.
排除标准
- •Under 18 years old.
- •Diagnosed with neuromuscular diseases.
- •Experienced respiratory disease exacerbation requiring emergency care or hospitalization in the past three months.
- •Unable to cooperate with cardiopulmonary exercise testing.
- •Has other diseases or behavioral restrictions preventing participation in exercise training for over one year.
- •Assessed by a physician to have severe malnutrition or a significantly low BMI.
研究组 & 干预措施
probiotic group
receive probiotics alongside standard pulmonary rehabilitation therapy
干预措施: probiotic supplementation intervention (Other)
pulmonary rehabilitation group
undergo only the standard pulmonary rehabilitation program
干预措施: standard pulmonnary rehabilitation (Other)
结局指标
主要结局
interleukin-6
时间窗: six weeks
inflammation evaluation
次要结局
- time up and go(six weeks)
- TMAO(six weeks)
- indirect calorimetry(six weeks)
- body composition analysis(six weeks)
- heart rate(six weeks)
- saturation(six weeks)
- systolic and diastolic pressure(six weeks)
- respiratory rate(six weeks)
- six minute walk test(six weeks)
- FEV1(six weeks)
- FVC(six weeks)
- FEV1/FVC(six weeks)
- CRP(six weeks)
- TNF-α(six weeks)
- The MDA of oxidative stress(six weeks)
- modified medical research council(six weeks)
- COPD assessment test(six weeks)
- Borg dyspnea scale(six weeks)
研究者
Ke-Yun, Chao
Assistant Professor
Fu Jen Catholic University