COPD
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTAstaxanthin
Two capsules of astaxanthin formula supplement daily for 8 weeks.
BEHAVIORALPulmonary rehabilitation training
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.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 * 3 or self-reported decline in physical function.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6MWD change from baseline of two groups | Baseline and 8 weeks | The minimal clinically important difference of 6-minute walking distance of two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life of two groups | Baseline and 8 weeks | 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). |
| Psychological status of two groups | Baseline and 8 weeks | 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). |
| Degree of dyspnea of two groups | Baseline and 8 weeks | 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). |
Contacts
CONTACTMingming Deng
Outcome results
None listed