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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-100
SponsorTaipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

About this trial

"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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Panic disorder.

Presence of delirium with inability to cooperate.

Currently receiving cancer treatment.

Angina pectoris or myocardial infarction within the past 3 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: walking exercise and resistance exercise with elastic bandExperimental treatment 3 interventions
Group B: routine nursing care and health educationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hospital Anxiety and Depression Scale (HADS)

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.

Time frame
Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.
2

modified Medical Research Council (mMRC)

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.

Time frame
Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.
3

COPD Assessment Test (CAT)

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.

Time frame
Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.
4

Chinese Version of the Pittsburgh Sleep Quality Index (CPSQI)

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.

Time frame
Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.

Secondary outcomes

1

Daily walking activity:(1)total steps

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.

Time frame
Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.
2

Daily walking activity:(2)total walking distance

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.

Time frame
Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.
3

Sleep status : (1)daily total sleep duration

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.

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

Sleep status : (2)daily light sleep duration

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.

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

Other outcomes

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