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

NCT07684391 | Not Yet Recruiting

• 1 other identifier: ZRJY2021-BJ08-01-03
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• 6MWD change from baseline of two groups

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

  Baseline and 8 weeks

Secondary Outcomes (3)

• Health-related quality of life of two groups

  Baseline and 8 weeks

• Psychological status of two groups

  Baseline and 8 weeks

• Degree of dyspnea of two groups

  Baseline and 8 weeks

Study Arms (2)

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.

Behavioral: Pulmonary rehabilitation training

Interventional group

EXPERIMENTAL

Participants in this group will receive an 8-week pulmonary rehabilitation training program combined with an astaxanthin dietary supplement.

Dietary Supplement: Astaxanthin; Behavioral: Pulmonary rehabilitation training

Interventions

Astaxanthin DIETARY_SUPPLEMENT

Two capsules of astaxanthin formula supplement daily for 8 weeks.

Interventional group

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.

Control group; Interventional group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who met the GOLD diagnostic criteria for stage II-IV COPD
• Patients who met the indications for pulmonary rehabilitation training: mMRC score
• or self-reported decline in physical function.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

astaxanthine

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mingming Deng

CONTACT

86 18801336854; isdeng1017@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-06