Effect of Oral Astaxanthin Formula on Pulmonary Rehabilitation in Patients With COPD
ConditionCOPD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChina-Japan Friendship Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Astaxanthin
Dietary supplementTwo capsules of astaxanthin formula supplement daily for 8 weeks.
Pulmonary rehabilitation training
BehavioralA 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Control groupPlacebo comparator 1 intervention
Group B: Interventional groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
6MWD change from baseline of two groups
The minimal clinically important difference of 6-minute walking distance of two groups.
Time frame
Baseline and 8 weeksSecondary outcomes
1
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).
Time frame
Baseline and 8 weeks2
Psychological status of two groups
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).
Time frame
Baseline and 8 weeks3
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).
Time frame
Baseline and 8 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: