The Effect of Walking Exercise in Patients With Chronic Obstructive Pulmonary Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Elastic band, Xiaomi Mi Band 4 wearable device, Walking.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: 40 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Walking Exercise on Anxiety, Depression, Dyspnea, Life and Sleep Quality in Patients With Chronic Obstructive Pulmonary Disease.
Overview
"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.
Interventions
- Device 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 - 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. - Behavioral Walking
Walking exercise plan
Primary outcome measures
- 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.]
- 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.]
- COPD Assessment Test (CAT) [Time frame: Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.]
- 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.]
- 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.]
Secondary outcome measures (7)
- 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.]
- 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.]
- 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.]
- 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.]
- 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.]
- 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.]
- 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.]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Taipei Tzu Chi Hospital — New Taipei City
Identifiers
NCT: NCT07185659 · 09-XD-098