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

Buddhist Tzu Chi Medical Foundation

Status: Enrolling

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Device: Xiaomi Mi Band 4 wearable device; Behavioral: Walking; Device: Elastic band

Study type: Interventional

Funder types: Other

Identifiers

NCT07185659

09-XD-098

Details and patient eligibility

About

"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).

Full description

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 40 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Exclusion Criteria:

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups, including a placebo group

walking exercise and resistance exercise with elastic band

Experimental group

Description:

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.

Treatment:

Device: Elastic band

Behavioral: Walking

Device: Xiaomi Mi Band 4 wearable device

routine nursing care and health education

Placebo Comparator group

Description:

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)

Treatment:

Device: Xiaomi Mi Band 4 wearable device