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

Sponsor
China-Japan Friendship Hospital
Study ID
NCT07684391
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jul 6, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Placebo Comparator: Control group
    Participants in this group will only receive an 8-week pulmonary rehabilitation training program and two placebo capsules daily for 8 weeks.
  • Experimental: Interventional group
    Participants in this group will receive an 8-week pulmonary rehabilitation training program combined with an astaxanthin dietary supplement.

Primary Outcome Measure

6MWD change from baseline of two groups [ Time Frame: Baseline and 8 weeks ]

Central Contacts

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