Effect of Oral Astaxanthin Formula Supplement on Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease: a Multicenter, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 主要终点
- 6MWD change from baseline of two groups
研究概览
简要总结
The goal of this clinical trial is to investigate whether an astaxanthin-based dietary supplement combined with a pulmonary rehabilitation training program could improve exercise capacity in patients with COPD. The main questions it aims to answer are:
• whether an astaxanthin-based dietary supplement combined with a pulmonary rehabilitation training program could improve 6MWD in patients with COPD.
The drug administration group will receive:
- Two capsules of astaxanthin formula supplement daily for 8 weeks.
- Pulmonary rehabilitation training: a total of 8 weeks, 2-3 times a week.
The control group will receive a total of 8-week pulmonary rehabilitation training, 2-3 times a week.
The investigators will compare the drug administration group and the control group to see if the difference between the 2 groups reaches a minimal clinically important difference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who met the GOLD diagnostic criteria for stage II-IV COPD
- •Patients who met the indications for pulmonary rehabilitation training: mMRC score
- •3 or self-reported decline in physical function.
排除标准
- •Hypoxemia (resting partial pressure of oxygen < 60mmHg or oxygen saturation < 88%) or patients requiring continuous oxygen therapy or with any contraindications to exercise testing (refer to the American Society of Thoracic Surgeons/American College of Chest Physicians exercise testing guidelines).
- •Using oral glucocorticoids
- •Long-term oxygen therapy
- •Participated in a supervised exercise program within the past 12 months
- •History of other pulmonary diseases, including pneumoconiosis, bronchiectasis, tuberculosis, primary pulmonary hypertension, pulmonary embolism, interstitial lung disease
- •Skeletal, neuromuscular, cardiovascular, or metabolic disorders that limit the participant's ability to exercise actively or that involve muscle activity, such as cancer, diabetes, muscle weakness, etc.
结局指标
主要结局
6MWD change from baseline of two groups
时间窗: Baseline and 8 weeks
The minimal clinically important difference of 6-minute walking distance of two groups.
次要结局
- Health-related quality of life of two groups(Baseline and 8 weeks)
- Psychological status of two groups(Baseline and 8 weeks)
- Degree of dyspnea of two groups(Baseline and 8 weeks)
研究者
Gang Hou
Principal Investigator
China-Japan Friendship Hospital