Идёт набор NCT07185659

The Effect of Walking Exercise in Patients With Chronic Obstructive Pulmonary Disease

Без фазы С лечением Chronic Obstructive Pulmonary Disease (COPD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Elastic band, Xiaomi Mi Band 4 wearable device, Walking.
Кому может быть актуально: Состояния в реестре: Chronic Obstructive Pulmonary Disease (COPD). Базовые параметры: 40 лет — 100 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Тайвань
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Effect of Walking Exercise on Anxiety, Depression, Dyspnea, Life and Sleep Quality in Patients With Chronic Obstructive Pulmonary Disease.

Обзор

"Patients were divided into two groups: the experimental group (E group) and the control group (C group). The E group received standard care, walking exercise, and elastic band exercise, and wore a smart bracelet to record walking steps and sleep for three months. During the first month, participants performed walking exercise for 100 minutes per week and used a red elastic band for resistance training. In the second month, walking exercise increased to 150 minutes per week with a green elastic band. In the third month, walking exercise increased to 150-300 minutes per week with a blue elastic band. The C group wore the smart bracelet to record walking steps and sleep for three months. Each group included 34 participants. The study was conducted from September 9, 2021, to December 31, 2025. Exclusion criteria included panic disorder, cognitive impairment, current cancer treatment, angina pectoris or myocardial infarction within the past 3 months, participation in high-intensity rehabilitation exercise, and walking dysfunction. Participants were required to follow the study protocol. * Assessments\*\*: * Anxiety and Depression\*\*:Measured using the Chinese version of the Hospital Anxiety and Depression Scale (HADS). * Dyspnea\*\*:Measured using the Modified Medical Research Council (mMRC) scale. * Life and Sleep quality\*\*:Measured using the COPD Assessment Test (CAT) and Chinese Version of the Pittsburgh Sleep Quality Index (CPSQI).

Подробное описание

Patients will be divided into two groups: the experimental group (E group) and the control group (C group).

The E group will receive standard care, walking exercise, and elastic band exercise, and will wear a smart bracelet to record walking steps and sleep for three months. During the first month, participants will perform walking exercise for 100 minutes per week and use a red elastic band for resistance training. In the second month, walking exercise will increase to 150 minutes per week with a green elastic band. In the third month, walking exercise will increase to 150-300 minutes per week with a blue elastic band.

The C group will wear a smart bracelet to record walking steps and sleep for three months.

Each group will enroll 34 participants. The study period is from September 9, 2021, to December 31, 2025. Participants with contraindications such as panic disorder, cognitive impairment, ongoing cancer treatment, angina pectoris or myocardial infarction within the past 3 months, participation in high-intensity rehabilitation exercise, or walking dysfunction will be excluded at enrollment based on the exclusion criteria. Participants are required to follow the study protocol.

Вмешательства

Устройство Elastic band
Thera-Band® elastic band exercise protocol: First stage (weeks 1-4): Participants performed leg resistance stretching exercises with a red elastic band. In weeks 1-2, exercises were performed 3 times per week, with 2 sets per session; in weeks 3-4, 3 times per week, with 3 sets per session. Second stage (weeks 5-8): Participants performed leg resistance stretching exercises with a green elastic band. In weeks 5-6, exercises were performed 3 times per week, with 2 sets per session; in weeks 7-8
Устройство Xiaomi Mi Band 4 wearable device
The Xiaomi Mi Band 4 wearable device has been certified by the National Communications Commission (Certification No. CCAG19LP0080T6). From weeks 1 to 12, participants' daily walking steps were monitored using the Xiaomi Mi Band 4 wearable device.
Поведенческое Walking
Walking exercise plan

Первичные конечные точки

Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.]
modified Medical Research Council (mMRC) [Срок оценки: Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.]
COPD Assessment Test (CAT) [Срок оценки: Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.]
Chinese Version of the Pittsburgh Sleep Quality Index (CPSQI) [Срок оценки: Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.]
Six-Minute Walk Test ( 6MWT ) [Срок оценки: Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.]

Вторичные конечные точки (7)

Daily walking activity:(1)total steps [Срок оценки: Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.]
Daily walking activity:(2)total walking distance [Срок оценки: Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.]
Sleep status : (1)daily total sleep duration [Срок оценки: Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.]
Sleep status : (2)daily light sleep duration [Срок оценки: Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.]
Sleep status : (3) Daily deep sleep duration [Срок оценки: Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.]
Sleep status : (4) the number of awakenings during sleep [Срок оценки: Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.]
Sleep status : (5) total wake time during sleep [Срок оценки: Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.]

Критерии участия

Participants were recruited according to the following criteria.

Критерии включения

Inpatients diagnosed with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
Age ≥ 40 years.
Post-bronchodilator FEV₁/FVC ratio < 70%.
History of smoking.
Ability to perform walking exercises.
Willingness of the patient or a family member to provide written informed consent.