COPDNCT04870632
Tele-based Resisted Exercise for COPD
A study testing Education, Video-based pulmonary rehabilitation and Booklet-based pulmonary rehabilitation in people with COPD and Pulmonary Rehabilitation, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The present study aims to investigate the effect of six weeks tele-based resisted exercises on cardiopulmonary function, quality of life, muscle strength and functioanl performance among patients with chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Pulmonary Rehabilitation, Telerehabilitation
- What is being tested?
- Education, Video-based pulmonary rehabilitation and Booklet-based pulmonary rehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Mar 2020to 10 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD
- Be medically stable
- Ability to use a smartphone and applications (LINE and Youtube)
- Access to the internet
- Have visual and auditory impairments corrected with assistive devices
Who cannot join
- Other respiratory disease as main complaint other than COPD
- Exacerbations within 4 weeks
- Had enrolled PR programs within the last 6 months
- Unable to follow verbal instructions, suffer from cognitive impairment, or have language difficulties
- Unstable medical conditions
- Any comorbidities which precluded exercise training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Six Weeks Tele-based Resistance Exercise Improves the Respiratory Muscle Strength and Biceps Strength Among Patients With Chronic Obstructive Pulmonary Disease
The present study aims to investigate the effect of six weeks tele-based resisted exercises on cardiopulmonary function, quality of life, muscle strength and functioanl performance among patients with chronic obstructive pulmonary disease. In addition, the effect of different forms of exercise instruction (i.e., booklet and video) was also investigated.
Read the detailed description
Background and Purpose: Chronic obstructive pulmonary disease (COPD) is the 3rd global cause of deaths. Pulmonary rehabilitation (PR) is the standard treatment for this disease. However, the dropout rate remains high (33-50%) because of traffic issues and patients' low mobility. Therefore, telerehabilitation seems to be a better way to deliver PR. Using videos to deliver PR is not only easy to manipulate on the cellphone or ipad, but also improve patients' attention and compliance. Thus, the aim of this study is to assess whether tailor-made PR video rehabilitation program improves patients' quality of life (QoL), muscle strengths, cardiopulmonary functions, and compliance.
Methods: This is a quasi-experimental study. Participants were medically stable COPD patients and able to use LINE and YOUTUBE in cellphone. They voluntarily choose to participate in control group, booklet group or video groups to conduct 6-week tele-based resisted exercise program. Patients in control group received conventional intervention and exercise instruction booklet. Participants in booklet and video groups additionally received a COPD exercise package with 2 elastic bands in different weight (4 ponds and 8 ponds). Participants in booklet group received the exercise instructed in education booklet with words and pictures. Patients in video group received exercise instructed using YouTube videos. Both participants in booklet and video groups were asked to record their rating of perceived exertion (RPE) scores. A physical therapist would weekly contact them to monitor and modify the exercise intensity using their RPE scores. The videos included 5-minute breathing reeducation, 20-minute interval strengthening exercise and 5-minute education animation. All patients were assessed the performance of spirometry, cardiopulmonary exercise test (CPET), questionnaires about symptoms, QoL, muscle strengths and distances of 6-minute walk test (6MWT) before intervention, after intervention and after 6-week follow-up.
- Conditions
- COPD, Pulmonary Rehabilitation, Telerehabilitation, Cardiopulmonary Exercise Test, Compliance, Patient
- Being tested
- Education, Video-based pulmonary rehabilitation, Booklet-based pulmonary rehabilitation
- Keywords
- COPD, Pulmonary Rehabilitation, Telerehabilitation, Video-based telerehabilitation, Youtube, LINE, Booklet-based telerehabilitation, Cardiopulmonary exercise test, Interval strengthening exercises, Cellphone
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
COPD patients conduct pulmonary rehabilitation for 6 weeks by read an education booklet with words and pictures which is made by the physiotherapist.
Video-based pulmonary rehabilitationOther
COPD patients conduct pulmonary rehabilitation for 6 weeks by watching Youtube videos which were made by the physiotherapist.The patients are monitored by the physiotherapist by weekly phone call and asked to record RPE scores at the RPE form.
Booklet-based pulmonary rehabilitationOther
COPD patients conduct pulmonary rehabilitation for 6 weeks by read an education booklet with words and pictures which is made by the physiotherapist.The patients are monitored by the physiotherapist by weekly phone call and asked to record RPE scores at the RPE form.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Patients in control group received the education booklet with words and pictures. Receives: Other: Education |
| Video group | Experimental | Patients in intervention group watched YOUTUBE videos to rehab and recorded the intensity after the exercise by RPE scores. During the intervention, a physical therapist would have weekly telephone calls or LINE calls for 6 times to monitor and modify the intensity of exercise. Receives: Other: Video-based pulmonary rehabilitation |
| Booklet group | Experimental | Patients in intervention group read education booklet with words and pictures to rehab and recorded the intensity after the exercise by RPE scores. During the intervention, a physical therapist would have weekly telephone calls or LINE calls for 6 times to monitor and modify the intensity of exercise. Receives: Other: Booklet-based pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time point difference of AT from 1st week to 6th week
Use cardiopulmonary exercise test (CPET) to get the change of time point difference of AT from 1st week(intervention starts) to 6th week(intervention ends)
Measured: From 1st week to 6th week
Time point difference of AT from 1st week to 12th week
Use cardiopulmonary exercise test (CPET) to get the change of time point difference of AT from 1st week(intervention starts) to 12th week(follow up ends)
Measured: From 1st week to 12th week
Time point difference of AT from 6th week to 12th week
Use cardiopulmonary exercise test (CPET) to get the change of time point of AT from 6th week(intervention ends) to 12th week(follow up ends)
Measured: From 6th week to 12th week
Change of maximal exercise work from 1st week to 6th week
Use cardiopulmonary exercise test (CPET) to get the change of values of the pateint's total work (watt) from 1st week(intervention starts) to 6th week(intervention ends)
Measured: From 1st week to 6th week
Change of maximal exercise work from 1st week to 12th week
Use cardiopulmonary exercise test (CPET) to get the change of values of the pateint's total work (watt) from 1st week(intervention starts) to to 12th week(follow up ends)
Measured: From 1st week to 12th week
Change of maximal exercise work from 6th week to 12th week
Use cardiopulmonary exercise test (CPET) to get the change of values of the pateint's total work (watt) from 6th week(intervention ends) to 12th week(follow up ends)
Measured: From 6th week to 12th week
Change of VO2max from 1st week to 6th week
Use cardiopulmonary exercise test (CPET) to get the change of values of VO2max (mL/min/kg) from 1st week(intervention starts) to 6th week(intervention ends)
Measured: From 1st week to 6th week
Change of VO2max from 1st week to 12th week
Use cardiopulmonary exercise test (CPET) to get the change of values of VO2max (mL/min/kg) from 1st week(intervention starts) to 12th week(follow up ends)
Measured: From 1st week to 12th week
Change of VO2max from 6th week to 12th week
Use cardiopulmonary exercise test (CPET) to get the change of values of VO2max (mL/min/kg) from 6th week(intervention ends) to 12th week(follow up ends)
Measured: From 6th week to 12th week
Change of VE/VCO2 from 1st week to 6th week
Use cardiopulmonary exercise test (CPET) to get the change of values of VE/VCO2 from 1st week(intervention starts) to 6th week(intervention ends)
Measured: From 1st week to 6th week
Change of VE/VCO2 from 1st week to 12th week
Use cardiopulmonary exercise test (CPET) to get the change of values of VE/VCO2 from 1st week(intervention starts) to 12th week(follow up ends)
Measured: From 1st week to 12th week
Change of VE/VCO2 from 6th week to 12th week
Use cardiopulmonary exercise test (CPET) to get the change of values of VE/VCO2 from 6th week(intervention ends) to 12th week(follow up ends)
Measured: From 6th week to 12th week
Change of muscle strength from 1st week to 6th week
Use dynamometer to measure the changes of muscle strength(kg) from 1st week(intervention starts) to 6th week(intervention ends), including bilateral handgrip, elbow flexors (biceps) and knee extensors (quadriceps) for 3 times separately.The patient need to increase the strength to the highest level in 6 seconds and rest for 30 seconds.The highest value will be divided by the patient's body weight (kg/kg)
Measured: From 1st week to 6th week
Change of muscle strength from 1st week to 12th week
Use dynamometer to measure the changes of muscle strength(kg) from 1st week(intervention starts) to 12th week(follow up ends), including bilateral handgrip, elbow flexors (biceps) and knee extensors (quadriceps) for 3 times separately.The patient need to increase the strength to the highest level in 6 seconds and rest for 30 seconds.The highest value will be divided by the patient's body weight (kg/kg)
Measured: From 1st week to 12th week
Change of muscle strength from 6th week to 12th week
Use dynamometer to measure the changes of muscle strength(kg) from 6th week(intervention ends) to 12th week(follow up ends), including bilateral handgrip, elbow flexors (biceps) and knee extensors (quadriceps) for 3 times separately.The patient need to increase the strength to the highest level in 6 seconds and rest for 30 seconds.The highest value will be divided by the patient's body weight (kg/kg)
Measured: From 6th week to 12th week
Change of 6-minute walk test from 1st week to 6th week
Measure the change of 6-minute walk test from 1st(intervention starts) week to 6th week(intervention ends).The patient walks in his/her own pace, as far as he/she can in 6 minutes at the 20-meter long straight path and the we will record the distance in meter.Stop when time's up or patient develops clinical symptoms.
Measured: From 1st week to 6th week
Change of 6-minute walk test from 1st week to 12th week
Measure the change of 6-minute walk test from 1st(intervention starts) week to 12th week(follow up ends).The patient walks in his/her own pace, as far as he/she can in 6 minutes at the 20-meter long straight path and the we will record the distance in meter.Stop when time's up or patient develops clinical symptoms.
Measured: From 1st week to 12th week
Change of 6-minute walk test from 6th week to 12th week
Measure the change of 6-minute walk test from 6th(intervention ends) week to 12th week(follow up ends).The patient walks in his/her own pace, as far as he/she can in 6 minutes at the 20-meter long straight path and the we will record the distance in meter.Stop when time's up or patient develops clinical symptoms.
Measured: From 6th week to 12th week
Attendance rate in video group or booklet group
If the patient completes 70% or more of the intervention program by being analyzed from the record of RPE form, he/she will be recognize as being completed the intervention.Finally, we will count the number of the patients who completed the intervention to be divided by the number of totally patients in video/booklet group at 6th week.
Measured: From 1st week to 6th week
Secondary outcomes (6)
FEV1
Use spirometry to measure the values of FEV1 (%) for 3 times.The highest result will be recored.
Measured: Baseline, 6 weeks later, and 12 weeks later
FEV1/FVC
Use spirometry to measure the values of FEV1/FVC for 3 times.The highest result will be recored.
Measured: Baseline, 6 weeks later, and 12 weeks later
Modified Medical Research Council (mMRC)
Level of Modified Medical Research Council (mMRC)
Measured: Baseline, 6 weeks later, and 12 weeks later
COPD Assessment Test (CAT)
Total score of COPD Assessment Test (CAT)
Measured: Baseline, 6 weeks later, and 12 weeks later
EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Score of EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Measured: Baseline, 6 weeks later, and 12 weeks later
Clinical COPD Questionnaires (CCQ)
Score of Clinical COPD Questionnaires (CCQ)
Measured: Baseline, 6 weeks later, and 12 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start2 Mar 2020
- Primary completion31 May 2021
- Study completion10 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ching-Hsia Hung, National Cheng-Kung University Hospital
- Investigators
- Ching-Hsia Hung, Ph.D, Study chair, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870632
- Sponsor's protocol ID
- B-BR-108-038-2
- Status last verified
- Jul 2024
- First submitted
- 14 Apr 2021
- Last updated
- 22 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Six Weeks Tele-based Resistance Exercise Improves the Respiratory Muscle Strength and Biceps Strength Among Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04870632
- Acronym / sponsor ID
- B-BR-108-038-2
- Conditions
- COPD, Pulmonary Rehabilitation, Telerehabilitation, Cardiopulmonary Exercise Test, Compliance, Patient
- Keywords
- COPD, Pulmonary Rehabilitation, Telerehabilitation, Video-based telerehabilitation, Youtube, LINE, Booklet-based telerehabilitation, Cardiopulmonary exercise test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 10 Jul 2021 (actual)
- First posted
- 3 May 2021 (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.
The present study aims to investigate the effect of six weeks tele-based resisted exercises on cardiopulmonary function, quality of life, muscle strength and functioanl performance among patients with chronic obstructive pulmonary disease. In addition, the effect of different forms of exercise instruction (i.e., booklet and video) was also investigated.
Detailed description
Background and Purpose: Chronic obstructive pulmonary disease (COPD) is the 3rd global cause of deaths. Pulmonary rehabilitation (PR) is the standard treatment for this disease. However, the dropout rate remains high (33-50%) because of traffic issues and patients' low mobility. Therefore, telerehabilitation seems to be a better way to deliver PR. Using videos to deliver PR is not only easy to manipulate on the cellphone or ipad, but also improve patients' attention and compliance. Thus, the aim of this study is to assess whether tailor-made PR video rehabilitation program improves patients' quality of life (QoL), muscle strengths, cardiopulmonary functions, and compliance.
Methods: This is a quasi-experimental study. Participants were medically stable COPD patients and able to use LINE and YOUTUBE in cellphone. They voluntarily choose to participate in control group, booklet group or video groups to conduct 6-week tele-based resisted exercise program. Patients in control group received conventional intervention and exercise instruction booklet. Participants in booklet and video groups additionally received a COPD exercise package with 2 elastic bands in different weight (4 ponds and 8 ponds). Participants in booklet group received the exercise instructed in education booklet with words and pictures. Patients in video group received exercise instructed using YouTube videos. Both participants in booklet and video groups were asked to record their rating of perceived exertion (RPE) scores. A physical therapist would weekly contact them to monitor and modify the exercise intensity using their RPE scores. The videos included 5-minute breathing reeducation, 20-minute interval strengthening exercise and 5-minute education animation. All patients were assessed the performance of spirometry, cardiopulmonary exercise test (CPET), questionnaires about symptoms, QoL, muscle strengths and distances of 6-minute walk test (6MWT) before intervention, after intervention and after 6-week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Other: EducationPatients in control group received the education booklet with words and pictures. |
| Video group | Experimental | Other: Video-based pulmonary rehabilitationPatients in intervention group watched YOUTUBE videos to rehab and recorded the intensity after the exercise by RPE scores. During the intervention, a physical therapist would have weekly telephone calls or LINE calls for 6 times to monitor and modify the intensity of exercise. |
| Booklet group | Experimental | Other: Booklet-based pulmonary rehabilitationPatients in intervention group read education booklet with words and pictures to rehab and recorded the intensity after the exercise by RPE scores. During the intervention, a physical therapist would have weekly telephone calls or LINE calls for 6 times to monitor and modify the intensity of exercise. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- COPD
- Be medically stable
- Ability to use a smartphone and applications (LINE and Youtube)
- Access to the internet
- Have visual and auditory impairments corrected with assistive devices
Key exclusion criteria (6 listed)
- Other respiratory disease as main complaint other than COPD
- Exacerbations within 4 weeks
- Had enrolled PR programs within the last 6 months
- Unable to follow verbal instructions, suffer from cognitive impairment, or have language difficulties
- Unstable medical conditions
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 |
|---|---|---|
| EducationCOPD patients conduct pulmonary rehabilitation for 6 weeks by read an education booklet with words and pictures which is made by the physiotherapist. | Other | Control group |
| Video-based pulmonary rehabilitationCOPD patients conduct pulmonary rehabilitation for 6 weeks by watching Youtube videos which were made by the physiotherapist.The patients are monitored by the physiotherapist by weekly phone call and asked to record RPE scores at the RPE form. | Other | Video group |
| Booklet-based pulmonary rehabilitationCOPD patients conduct pulmonary rehabilitation for 6 weeks by read an education booklet with words and pictures which is made by the physiotherapist.The patients are monitored by the physiotherapist by weekly phone call and asked to record RPE scores at the RPE form. | Other | Booklet group |
Primary outcome
Time point difference of AT from 1st week to 6th week
Time frame: From 1st week to 6th week
Use cardiopulmonary exercise test (CPET) to get the change of time point difference of AT from 1st week(intervention starts) to 6th week(intervention ends)
Time point difference of AT from 1st week to 12th week
Time frame: From 1st week to 12th week
Use cardiopulmonary exercise test (CPET) to get the change of time point difference of AT from 1st week(intervention starts) to 12th week(follow up ends)
Time point difference of AT from 6th week to 12th week
Time frame: From 6th week to 12th week
Use cardiopulmonary exercise test (CPET) to get the change of time point of AT from 6th week(intervention ends) to 12th week(follow up ends)
Change of maximal exercise work from 1st week to 6th week
Time frame: From 1st week to 6th week
Use cardiopulmonary exercise test (CPET) to get the change of values of the pateint's total work (watt) from 1st week(intervention starts) to 6th week(intervention ends)
Change of maximal exercise work from 1st week to 12th week
Time frame: From 1st week to 12th week
Use cardiopulmonary exercise test (CPET) to get the change of values of the pateint's total work (watt) from 1st week(intervention starts) to to 12th week(follow up ends)
Change of maximal exercise work from 6th week to 12th week
Time frame: From 6th week to 12th week
Use cardiopulmonary exercise test (CPET) to get the change of values of the pateint's total work (watt) from 6th week(intervention ends) to 12th week(follow up ends)
Change of VO2max from 1st week to 6th week
Time frame: From 1st week to 6th week
Use cardiopulmonary exercise test (CPET) to get the change of values of VO2max (mL/min/kg) from 1st week(intervention starts) to 6th week(intervention ends)
Change of VO2max from 1st week to 12th week
Time frame: From 1st week to 12th week
Use cardiopulmonary exercise test (CPET) to get the change of values of VO2max (mL/min/kg) from 1st week(intervention starts) to 12th week(follow up ends)
Change of VO2max from 6th week to 12th week
Time frame: From 6th week to 12th week
Use cardiopulmonary exercise test (CPET) to get the change of values of VO2max (mL/min/kg) from 6th week(intervention ends) to 12th week(follow up ends)
Change of VE/VCO2 from 1st week to 6th week
Time frame: From 1st week to 6th week
Use cardiopulmonary exercise test (CPET) to get the change of values of VE/VCO2 from 1st week(intervention starts) to 6th week(intervention ends)
Change of VE/VCO2 from 1st week to 12th week
Time frame: From 1st week to 12th week
Use cardiopulmonary exercise test (CPET) to get the change of values of VE/VCO2 from 1st week(intervention starts) to 12th week(follow up ends)
Change of VE/VCO2 from 6th week to 12th week
Time frame: From 6th week to 12th week
Use cardiopulmonary exercise test (CPET) to get the change of values of VE/VCO2 from 6th week(intervention ends) to 12th week(follow up ends)
Change of muscle strength from 1st week to 6th week
Time frame: From 1st week to 6th week
Use dynamometer to measure the changes of muscle strength(kg) from 1st week(intervention starts) to 6th week(intervention ends), including bilateral handgrip, elbow flexors (biceps) and knee extensors (quadriceps) for 3 times separately.The patient need to increase the strength to the highest level in 6 seconds and rest for 30 seconds.The highest value will be divided by the patient's body weight (kg/kg)
Change of muscle strength from 1st week to 12th week
Time frame: From 1st week to 12th week
Use dynamometer to measure the changes of muscle strength(kg) from 1st week(intervention starts) to 12th week(follow up ends), including bilateral handgrip, elbow flexors (biceps) and knee extensors (quadriceps) for 3 times separately.The patient need to increase the strength to the highest level in 6 seconds and rest for 30 seconds.The highest value will be divided by the patient's body weight (kg/kg)
Change of muscle strength from 6th week to 12th week
Time frame: From 6th week to 12th week
Use dynamometer to measure the changes of muscle strength(kg) from 6th week(intervention ends) to 12th week(follow up ends), including bilateral handgrip, elbow flexors (biceps) and knee extensors (quadriceps) for 3 times separately.The patient need to increase the strength to the highest level in 6 seconds and rest for 30 seconds.The highest value will be divided by the patient's body weight (kg/kg)
Change of 6-minute walk test from 1st week to 6th week
Time frame: From 1st week to 6th week
Measure the change of 6-minute walk test from 1st(intervention starts) week to 6th week(intervention ends).The patient walks in his/her own pace, as far as he/she can in 6 minutes at the 20-meter long straight path and the we will record the distance in meter.Stop when time's up or patient develops clinical symptoms.
Change of 6-minute walk test from 1st week to 12th week
Time frame: From 1st week to 12th week
Measure the change of 6-minute walk test from 1st(intervention starts) week to 12th week(follow up ends).The patient walks in his/her own pace, as far as he/she can in 6 minutes at the 20-meter long straight path and the we will record the distance in meter.Stop when time's up or patient develops clinical symptoms.
Change of 6-minute walk test from 6th week to 12th week
Time frame: From 6th week to 12th week
Measure the change of 6-minute walk test from 6th(intervention ends) week to 12th week(follow up ends).The patient walks in his/her own pace, as far as he/she can in 6 minutes at the 20-meter long straight path and the we will record the distance in meter.Stop when time's up or patient develops clinical symptoms.
Attendance rate in video group or booklet group
Time frame: From 1st week to 6th week
If the patient completes 70% or more of the intervention program by being analyzed from the record of RPE form, he/she will be recognize as being completed the intervention.Finally, we will count the number of the patients who completed the intervention to be divided by the number of totally patients in video/booklet group at 6th week.
6 secondary outcomes
FEV1
Time frame: Baseline, 6 weeks later, and 12 weeks later
FEV1/FVC
Time frame: Baseline, 6 weeks later, and 12 weeks later
Modified Medical Research Council (mMRC)
Time frame: Baseline, 6 weeks later, and 12 weeks later
COPD Assessment Test (CAT)
Time frame: Baseline, 6 weeks later, and 12 weeks later
EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Time frame: Baseline, 6 weeks later, and 12 weeks later
Clinical COPD Questionnaires (CCQ)
Time frame: Baseline, 6 weeks later, and 12 weeks later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ching-Hsia Hung, Ph.D study chair
National Cheng-Kung University 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 Education, Video-based pulmonary rehabilitation and Booklet-based pulmonary rehabilitation in people with COPD and Pulmonary Rehabilitation, run by National Cheng-Kung University Hospital 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 22 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time point difference of AT from 1st week to 6th week (time frame: From 1st week to 6th week). The study lists 19 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 Jul 2024; AzTrials last refreshed its copy on 26 Oct 2026.