The Effect of Walking Exercise on Anxiety, Depression, Dyspnea, Life and Sleep Quality in Patients With Chronic Obstructive Pulmonary Disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
"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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants were recruited according to the following criteria.
- •Inclusion Criteria:
- •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.
排除标准
- •Panic disorder.
- •Presence of delirium with inability to cooperate.
- •Currently receiving cancer treatment.
- •Angina pectoris or myocardial infarction within the past 3 months.
- •Currently undergoing high-intensity rehabilitation exercises.
研究组 & 干预措施
walking exercise and resistance exercise with elastic band
From weeks 1 to 12, participants' daily walking steps were monitored using a wearable device (smart bracelet).
Participants performed walking exercises 5 days per week, twice daily (morning and evening sessions). In weeks 1-4, the prescribed dose was 100 minutes per week (10 minutes per session); in weeks 5-8, 150 minutes per week (15 minutes per session); and in weeks 9-12, 150 to 300 minutes per week (20 to 30 minutes per session).
Leg resistance extension exercises were also performed with progressively stronger elastic bands: red (weeks 1-4), green (weeks 5-8), and blue (weeks 9-12). During weeks 1-2 and 5-6, exercises were performed 3 times per week with 2 sets per session, which increased to 3 sets per session during weeks 3-4, 7-8, and 11-12.
干预措施: Elastic band (Device)
walking exercise and resistance exercise with elastic band
From weeks 1 to 12, participants' daily walking steps were monitored using a wearable device (smart bracelet).
Participants performed walking exercises 5 days per week, twice daily (morning and evening sessions). In weeks 1-4, the prescribed dose was 100 minutes per week (10 minutes per session); in weeks 5-8, 150 minutes per week (15 minutes per session); and in weeks 9-12, 150 to 300 minutes per week (20 to 30 minutes per session).
Leg resistance extension exercises were also performed with progressively stronger elastic bands: red (weeks 1-4), green (weeks 5-8), and blue (weeks 9-12). During weeks 1-2 and 5-6, exercises were performed 3 times per week with 2 sets per session, which increased to 3 sets per session during weeks 3-4, 7-8, and 11-12.
干预措施: Xiaomi Mi Band 4 wearable device (Device)
walking exercise and resistance exercise with elastic band
From weeks 1 to 12, participants' daily walking steps were monitored using a wearable device (smart bracelet).
Participants performed walking exercises 5 days per week, twice daily (morning and evening sessions). In weeks 1-4, the prescribed dose was 100 minutes per week (10 minutes per session); in weeks 5-8, 150 minutes per week (15 minutes per session); and in weeks 9-12, 150 to 300 minutes per week (20 to 30 minutes per session).
Leg resistance extension exercises were also performed with progressively stronger elastic bands: red (weeks 1-4), green (weeks 5-8), and blue (weeks 9-12). During weeks 1-2 and 5-6, exercises were performed 3 times per week with 2 sets per session, which increased to 3 sets per session during weeks 3-4, 7-8, and 11-12.
干预措施: Walking (Behavioral)
routine nursing care and health education
Participants received routine nursing care and health education. From weeks 1 to 12, their daily walking steps were monitored using a wearable device (smart bracelet)
干预措施: Xiaomi Mi Band 4 wearable device (Device)
结局指标
主要结局
Hospital Anxiety and Depression Scale (HADS)
时间窗: Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.
HADS was used to assess differences between groups and over time. The questionnaire consists of 14 items: 7 for anxiety and 7 for depression. Scores range from 0 to 21 for each subscale, with higher scores indicating greater levels of anxiety and depression.
modified Medical Research Council (mMRC)
时间窗: Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.
The mMRC scale was used to assess differences in dyspnea severity between groups over time. The mMRC is a five-point scale ranging from 0 (least severe) to 4 (most severe), with higher scores indicating greater dyspnea severity.
COPD Assessment Test (CAT)
时间窗: Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.
The COPD Assessment Test (CAT) was used to assess differences between groups over time. The CAT consists of 8 items scored from 0 to 5, yielding a total score of 0 to 40, with higher scores indicating a greater impact of COPD on quality of life.
Chinese Version of the Pittsburgh Sleep Quality Index (CPSQI)
时间窗: Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.
CPSQI was used to assess differences between groups over time. Scores range from 0 to 21, with higher scores indicating poorer sleep quality. A score greater than 5 denotes poor sleep quality.
Six-Minute Walk Test ( 6MWT )
时间窗: Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.
The six-minute walk test (6MWT) was used to assess differences between groups and over time. It is an important measure of patients' functional exercise capacity.
次要结局
- Daily walking activity:(1)total steps(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(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(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(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(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(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(Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.)
研究者
Pei-Ching Hung
HEAD NURSE
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation