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

NCT ID: NCT07185659

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-09
• Study Completion Date: 2025-12-31

Brief Summary

"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).

Detailed 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Elastic band

Intervention Type: DEVICE

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, 3 times per week, with 3 sets per session.

Third stage (weeks 9-12): Participants performed leg resistance stretching exercises with a blue elastic band. In weeks 9-10, exercises were performed 3 times per week, with 2 sets per session; in weeks 11-12, 3 times per week, with 3 sets per session.

Xiaomi Mi Band 4 wearable device

Intervention Type: 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.

Walking

Intervention Type: BEHAVIORAL

Walking exercise plan

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)

Group Type: PLACEBO_COMPARATOR

Xiaomi Mi Band 4 wearable device

Intervention Type: 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.

Interventions

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, 3 times per week, with 3 sets per session.

Third stage (weeks 9-12): Participants performed leg resistance stretching exercises with a blue elastic band. In weeks 9-10, exercises were performed 3 times per week, with 2 sets per session; in weeks 11-12, 3 times per week, with 3 sets per session.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Walking

Walking exercise plan

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

Pei-Ching Hung

HEAD NURSE

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pei-Ching Hung, Hand nurse

Role: PRINCIPAL_INVESTIGATOR

Taipei Tzuchi hospital

Locations

Taipei Tzu Chi Hospital

New Taipei City, Xindian Dist., Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Pei-Ching Hung, Head nurse

Role: CONTACT

linda8123@hotmail.com

+886-2-66289779 ext. 8613

Facility Contacts

Pei-Ching Hung, Hand nurse

Role: primary

linda8123@hotmail.com

886-2-66289779 ext. 8613

Other Identifiers

09-XD-098

Identifier Type: -

Identifier Source: org_study_id