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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Participants in this group will only receive an 8-week pulmonary rehabilitation training program and two placebo capsules daily for 8 weeks. |
|
| Interventional group | Experimental | Participants in this group will receive an 8-week pulmonary rehabilitation training program combined with an astaxanthin dietary supplement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Astaxanthin | Dietary Supplement | Two capsules of astaxanthin formula supplement daily for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6MWD change from baseline of two groups | The minimal clinically important difference of 6-minute walking distance of two groups. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life of two groups | Using the COPD Assessment Test (CAT) to assess health-related quality of life. The CAT score ranges from 0 to 40, with higher scores indicating a worse outcome (a more severe impact of COPD on a patient's life). | Baseline and 8 weeks |
| Psychological status of two groups |
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Inclusion Criteria:
Patients who met the GOLD diagnostic criteria for stage II-IV COPD
Patients who met the indications for pulmonary rehabilitation training: mMRC score
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingming Deng | Contact | 86 18801336854 | isdeng1017@163.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C005948 | astaxanthine |
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| Pulmonary rehabilitation training | Behavioral | A total of 8 weeks, 2-3 times per week. 1) Patient education: once a week, including disease explanation, chronic disease self-management awareness, and medication guidance. 2) Exercise training: 60 minutes each time, including 10 minutes of warm-up exercise, 40 minutes of aerobic exercise, and 10 minutes of stretching and relaxation (monitoring participants' working frequency, SpO2, heart rate, dyspnea score, and leg fatigue during exercise). 3) 20-min lower extremity endurance training (treadmill walking or treadmill exercise at 60% of 6MWT speed). 4) 20 minutes of lower limb strength training: squats, jump rope, straight leg raising exercises, etc. |
|
Using the Hospital Anxiety and Depression Scale (HADS) to evaluate psychological status. The HADS consists of two subscales (Anxiety and Depression), each ranging from 0 to 21, for a maximum total score of 42. Higher scores indicate a worse outcome (higher levels of anxiety and depression). |
| Baseline and 8 weeks |
| Degree of dyspnea of two groups | Degree of dyspnea was assessed using the Modified Medical Research Council (mMRC) dyspnea scale. The mMRC scale ranges from 0 to 4, with higher scores indicating a worse outcome (more severe breathlessness). | Baseline and 8 weeks |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |