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NCT Number: NCT07185659

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

"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).

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Tzu Chi Hospital

New Taipei City, Xindian Dist., 23142, Taiwan

Location status: Recruiting

Location contact

Pei-Ching Hung, Hand nurse

CONTACT

[email protected]

886-2-66289779 ext. 8613

Pei-Ching Hung, Hand nurse

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Elastic band

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

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

Behavioral

Walking exercise plan

Primary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

  2. modified Medical Research Council (mMRC)

    Time frame: 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.

  3. COPD Assessment Test (CAT)

    Time frame: 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.

  4. Chinese Version of the Pittsburgh Sleep Quality Index (CPSQI)

    Time frame: 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.

  5. Six-Minute Walk Test ( 6MWT )

    Time frame: 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.

Secondary outcomes

  1. Daily walking activity:(1)total steps

    Time frame: Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.

    The Xiaomi Mi Band 4 wearable device will be used to measure daily walking activity, including total steps. Data will be collected to compare differences between two groups over time. By analyzing changes in walking activity over a 12-week period, the effectiveness of the therapeutic intervention will be evaluated.

  2. Daily walking activity:(2)total walking distance

    Time frame: Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.

    The Xiaomi Mi Band 4 wearable device will be used to measure daily walking activity, including total walking distance. Data will be collected to compare differences between two groups over time. By analyzing changes in walking activity over a 12-week period, the effectiveness of the therapeutic intervention will be evaluated.

  3. Sleep status : (1)daily total sleep duration

    Time frame: Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.

    Daily total sleep duration (in hours) was measured using the Xiaomi Mi Band 4 wearable device. The data were collected to evaluate between-group differences and temporal changes. The effectiveness of the therapeutic intervention was investigated by comparing differences in sleep status over 12 weeks.

  4. Sleep status : (2)daily light sleep duration

    Time frame: Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.

    Daily light sleep duration (hours) was measured using the Xiaomi Mi Band 4 wearable device. Data were collected to assess between-group differences and temporal changes. The effectiveness of the therapeutic intervention was evaluated by examining changes in sleep status over 12 weeks.

  5. Sleep status : (3) Daily deep sleep duration

    Time frame: Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.

    Daily deep sleep duration (hours) was measured using the Xiaomi Mi Band 4 wearable device. Data were collected to assess between-group differences and temporal changes. The effectiveness of the therapeutic intervention was evaluated by examining changes in sleep status over 12 weeks.

  6. Sleep status : (4) the number of awakenings during sleep

    Time frame: Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.

    The number of awakenings during sleep was measured using the Xiaomi Mi Band 4 wearable device. Data were collected to assess between-group differences and temporal changes. The effectiveness of the therapeutic intervention was evaluated by examining changes in sleep status over 12 weeks.

  7. Sleep status : (5) total wake time during sleep

    Time frame: Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.

    Total wake time during sleep was measured using the Xiaomi Mi Band 4 wearable device. Data were collected to assess between-group differences and temporal changes. The effectiveness of the therapeutic intervention was evaluated by analyzing longitudinal changes in sleep status over 12 weeks."

Study contacts

Contact information is provided by the study sponsor or research team.

Pei-Ching Hung, Head nurse

CONTACT

[email protected]

+886-2-66289779 ext. 8613

Sponsors and collaborators

Lead sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Other

Registry information

Official study title

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

Acronym: COPD

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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