- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04870632
Telerehabilitation Improves QoL, Physical Functions and Compliance in Patients With COPD
Personalized Video-delivered Telerehabilitation Improves QoL, Muscle Strengths, Cardiopulmonary Functions and Compliance in Patients With COPD
Study Overview
Status
Conditions
Intervention / Treatment
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 randomized controlled trial with 6-week follow-up. Participants were medically stable COPD patients and able to use LINE and YOUTUBE in cellphone. In the process of recruitment, they were all assessed by time-up-and-go test. The performance of time-up-and-go test should be lower than 12 seconds to rule out the participants with high risks of falling. They were randomly assigned to control group or intervention group to conduct 6-week home-based PR program. Patients in control group received the education booklet with words and pictures. 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. 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
SHAM_COMPARATOR: Control group
Patients in control group received the education booklet with words and pictures.
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COPD patients conduct pulmonary rehabilitation for 6 weeks by read an education booklet with words and pictures which is made by the physiotherapist.
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EXPERIMENTAL: Video group
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.
|
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.
|
EXPERIMENTAL: Booklet group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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From 1st week to 6th week
|
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)
|
From 1st week to 12th week
|
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)
|
From 6th week to 12th week
|
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)
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From 1st week to 6th week
|
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)
|
From 1st week to 12th week
|
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)
|
From 6th week to 12th week
|
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)
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From 1st week to 6th week
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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)
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From 1st week to 12th week
|
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)
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From 6th week to 12th week
|
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)
|
From 1st week to 6th week
|
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)
|
From 1st week to 12th week
|
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)
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From 6th week to 12th week
|
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)
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From 1st week to 6th week
|
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)
|
From 1st week to 12th week
|
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)
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From 6th week to 12th week
|
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.
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From 1st week to 6th week
|
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.
|
From 1st week to 12th week
|
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.
|
From 6th week to 12th week
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Attendance rate in video group or booklet group
Time Frame: From 1st week to 6th week
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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.
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From 1st week to 6th week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FEV1
Time Frame: Baseline, 6 weeks later, and 12 weeks later
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Use spirometry to measure the values of FEV1 (%) for 3 times.The highest result will be recored.
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Baseline, 6 weeks later, and 12 weeks later
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FEV1/FVC
Time Frame: Baseline, 6 weeks later, and 12 weeks later
|
Use spirometry to measure the values of FEV1/FVC for 3 times.The highest result will be recored.
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Baseline, 6 weeks later, and 12 weeks later
|
Modified Medical Research Council (mMRC)
Time Frame: Baseline, 6 weeks later, and 12 weeks later
|
Level of Modified Medical Research Council (mMRC)
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Baseline, 6 weeks later, and 12 weeks later
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COPD Assessment Test (CAT)
Time Frame: Baseline, 6 weeks later, and 12 weeks later
|
Total score of COPD Assessment Test (CAT)
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Baseline, 6 weeks later, and 12 weeks later
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EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Time Frame: Baseline, 6 weeks later, and 12 weeks later
|
Score of EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
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Baseline, 6 weeks later, and 12 weeks later
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Clinical COPD Questionnaires (CCQ)
Time Frame: Baseline, 6 weeks later, and 12 weeks later
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Score of Clinical COPD Questionnaires (CCQ)
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Baseline, 6 weeks later, and 12 weeks later
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- B-BR-108-038-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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