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Not yet recruiting NCT07684391

Effect of Oral Astaxanthin Formula on Pulmonary Rehabilitation in Patients With COPD

No phase Interventional COPD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Astaxanthin, Pulmonary rehabilitation training.
Who it may be relevant to
Registry conditions: COPD. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of Oral Astaxanthin Formula Supplement on Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease: a Multicenter, Randomized Controlled Study

Overview

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 supplement Astaxanthin
    Two capsules of astaxanthin formula supplement daily for 8 weeks.
  • Behavioral Pulmonary 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 (treadm

Primary outcome measures

  • 6MWD change from baseline of two groups [Time frame: Baseline and 8 weeks]
Secondary outcome measures (3)
  • Health-related quality of life of two groups [Time frame: Baseline and 8 weeks]
  • Psychological status of two groups [Time frame: Baseline and 8 weeks]
  • Degree of dyspnea of two groups [Time frame: Baseline and 8 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07684391 · ZRJY2021-BJ08-01-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗