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

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка Astaxanthin
  Two capsules of astaxanthin formula supplement daily for 8 weeks.
• Поведенческое 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

Первичные конечные точки

• 6MWD change from baseline of two groups [Срок оценки: Baseline and 8 weeks]

Вторичные конечные точки (3)

• Health-related quality of life of two groups [Срок оценки: Baseline and 8 weeks]
• Psychological status of two groups [Срок оценки: Baseline and 8 weeks]
• Degree of dyspnea of two groups [Срок оценки: Baseline and 8 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07684391 · ZRJY2021-BJ08-01-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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