Chronic Obstructive Pulmonary Disease (COPD)COPDNCT07185659
The Effect of Walking Exercise in Patients With Chronic Obstructive Pulmonary Disease
A study testing Elastic band, Xiaomi Mi Band 4 wearable device and Walking in people with Chronic Obstructive Pulmonary Disease (COPD), run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Elastic band, Xiaomi Mi Band 4 wearable device and Walking
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Sep 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Tzu Chi Hospital
New Taipei City, Xindian Dist., 23142
Pei-Ching Hung, Hand nurse, 886-2-66289779 ext. 8613, linda8123@hotmail.com
Pei-Ching Hung, Hand nurse
About this study
Official title: The Effect of Walking Exercise on Anxiety, Depression, Dyspnea, Life and Sleep Quality 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).
Read the 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.
- Being tested
- Elastic band, Xiaomi Mi Band 4 wearable device, Walking
- Keywords
- Chronic obstructive pulmonary disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic bandDevice
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 deviceDevice
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.
WalkingBehavioural
Walking exercise plan
| Study group | Role | What they receive |
|---|---|---|
| walking exercise and resistance exercise with elastic band | Experimental | 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. Receives: Device: Elastic band; Device: Xiaomi Mi Band 4 wearable device; Behavioral: Walking |
| routine nursing care and health education | Placebo comparator | 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) Receives: Device: Xiaomi Mi Band 4 wearable device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.
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.
Measured: Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.
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.
Measured: 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)
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.
Measured: Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.
Six-Minute Walk Test ( 6MWT )
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.
Measured: Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.
Secondary outcomes (7)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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."
Measured: Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start9 Sep 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly assigned to either the experimental group (E group) or the control group (C group). The experimental 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 control group wore a smart bracelet to record walking steps and sleep for three months but did not participate in the structured exercise program
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei-Ching Hung, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Investigators
- Pei-Ching Hung, Hand nurse, Principal investigator, Taipei Tzuchi hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185659
- Sponsor's protocol ID
- 09-XD-098
- Acronym
- COPD
- Status last verified
- Sep 2025
- First submitted
- 19 Feb 2023
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protecting participant privacy is the primary consideration, as sharing individual participant data (IPD) could expose sensitive information and create risks of re-identification, even after de-identification. Moreover, participants did not provide consent for data sharing, and obtaining re-consent would be difficult. Ensuring data security also requires substantial resources and technical safeguards that exceed our current infrastructure. In addition, compliance with complex legal and ethical regulations governing data sharing further complicates implementation. Finally, maintaining the quality and integrity of IPD prior to sharing demands additional effort and resources. Collectively, these factors inform our decision to prioritize participant protection and data security.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Walking Exercise on Anxiety, Depression, Dyspnea, Life and Sleep Quality in Patients With Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT07185659
- Acronym / sponsor ID
- COPD / 09-XD-098
- Keywords
- Chronic obstructive pulmonary disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients were randomly assigned to either the experimental group (E group) or the control group (C group). The experimental 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 control group wore a smart bracelet to record walking steps and sleep for three months but did not participate in the structured exercise program
| Arm | Type | Receives |
|---|---|---|
| walking exercise and resistance exercise with elastic band | Experimental | Device: Elastic band, Device: Xiaomi Mi Band 4 wearable device, Behavioral: WalkingFrom 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. |
| routine nursing care and health education | Placebo comparator | Device: Xiaomi Mi Band 4 wearable deviceParticipants received routine nursing care and health education. From weeks 1 to 12, their daily walking steps were monitored using a wearable device (smart bracelet) |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elastic bandThera-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. | Device | walking exercise and resistance exercise with elastic band |
| Xiaomi Mi Band 4 wearable deviceThe 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. | Device | routine nursing care and health education, walking exercise and resistance exercise with elastic band |
| WalkingWalking exercise plan | Behavioural | walking exercise and resistance exercise with elastic band |
Primary outcome
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.
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.
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.
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.
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.
7 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No. Protecting participant privacy is the primary consideration, as sharing individual participant data (IPD) could expose sensitive information and create risks of re-identification, even after de-identification. Moreover, participants did not provide consent for data sharing, and obtaining re-consent would be difficult. Ensuring data security also requires substantial resources and technical safeguards that exceed our current infrastructure. In addition, compliance with complex legal and ethical regulations governing data sharing further complicates implementation. Finally, maintaining the quality and integrity of IPD prior to sharing demands additional effort and resources. Collectively, these factors inform our decision to prioritize participant protection and data security.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pei-Ching Hung, Hand nurse principal investigator
Taipei Tzuchi hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastic band, Xiaomi Mi Band 4 wearable device and Walking in people with Chronic Obstructive Pulmonary Disease (COPD), run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pei-Ching Hung, Head nurse (+886-2-66289779 ext. 8613, linda8123@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.