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NCT Number: NCT07684391

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

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Astaxanthin

Dietary Supplement

Two capsules of astaxanthin formula supplement daily for 8 weeks.

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.

Primary outcomes

  1. 6MWD change from baseline of two groups

    Time frame: Baseline and 8 weeks

    The minimal clinically important difference of 6-minute walking distance of two groups.

Secondary outcomes

  1. Health-related quality of life of two groups

    Time frame: 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).

  2. Psychological status of two groups

    Time frame: 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).

  3. Degree of dyspnea of two groups

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Mingming Deng

CONTACT

[email protected]

86 18801336854

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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