Respiratory DiseaseNCT03432117
Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases
A study testing Fixed respiratory rehabilitation and Responsive respiratory rehabilitation in people with Respiratory Disease and Lung Cancer, run by Asan Medical Center at 5 sites in South Korea.
Trial summary
This trial is multicenter prospective study to evaluate clinical efficacy of respiratory rehabilitation personalized mobile services for respiratory disease. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Respiratory Disease, Lung Cancer, COPD
- What is being tested?
- Fixed respiratory rehabilitation and Responsive respiratory rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 15 May 2017to 6 Jan 2018
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Lung cancer or COPD
- Patients with FEV1<80% or FVC<80% in Pulmonary function test
- In case of COPD, post-bronchodilator FEV1 or FVC will be used.
- Exceptionally Lung Cancer patients with operation, FEV1>80% or FVC>80% will be permitted
- The distance walked for 6 minutes in 6-minute walk test ≥ 150 m
- Patients with android phone
- Patients who voluntarily agree to study participation and provide written informed consent form
Who cannot join
- Patients with diseases which could be cause of death or significant disability for 1 year after study enrollment.
- Patients with diseases that are difficult to walk or improve walking at screening
- Patients with significant diseases which are difficult to include in this study in accordance with the investigator's judgment
- Patients who are illiterate or have communication limitations
- Patients who have a difficulty to complete a questionnaire or are uncooperative due to deterioration of recognition function
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 11923
KyungHee University Medical Center
Seoul, 02447
Asan Medical Center
Seoul, 05505
Smg-Snu Boramae Medical Center
Seoul, 07061
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
About this study
Official title: Multicenter Prospective Clinical Trial to Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases
This trial is multicenter prospective study to evaluate clinical efficacy of respiratory rehabilitation personalized mobile services for respiratory disease.
Read the detailed description
Patients with Lung Cancer or COPD who need respiratory rehabilitation were enrolled in this trial. The subjets were randomized to 3 group(A: Fixed respiratory rehabilitation program group, B: Mixed respiratory rehabilitation program group(Fixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks) and C: Control group(Ordinary rehabilitation service of the site)).
Patients in Group A\&B were provided with mobile application and wearable O2 saturation machine and mobile application monitors physical activity and provides
- how to do stretching, weight training with The-ra Band
- daily and weekly target of exercise
- alarm algorithms depending on patient's respiratory status(purse rate and O2 saturation)
- Conditions
- Respiratory Disease, Lung Cancer, COPD
- Being tested
- Fixed respiratory rehabilitation, Responsive respiratory rehabilitation
- Keywords
- respiratory rehabilitation, personalized mobile services
- Medical subject headings
- Respiration Disorders, Lung Neoplasms, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed respiratory rehabilitationOther
There are 6 step-exercise presented in the application and initial target of exercise will be set according to subject condition. After subject completes targeted exercise, next step will be started.
Responsive respiratory rehabilitationOther
The application provide responsive exercise program by changing type and numbers of exercise according to subject condition and exercise ability (This will be assessed with monitored O2 saturation, symptom of dyspnea and pulse rate during exercise)
| Study group | Role | What they receive |
|---|---|---|
| Fixed respiratory rehabilitation program(A) | Experimental | respiratory rehabilitation program for 12 weeks Receives: Other: Fixed respiratory rehabilitation |
| Mixed respiratory rehabilitation program(B) | Experimental | Fixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks Receives: Other: Fixed respiratory rehabilitation; Other: Responsive respiratory rehabilitation |
| Control(C) | No intervention | Ordinary rehabilitation service of the site for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in Modified Medical Research Council dyspnea score
The MMRC dyspnea scale is a five-option grading system. The scale measures a person's limitation base on a scale of 0-4 and uses the final value to determine how much disability is caused by shortness of breath.
Measured: 12 weeks
change from baseline in COPD Assessment Test(CAT) score
The CAT is a validated, short and simple subject completed questionnaire which has been developed for use in routine clinical practice to measure the health status of subjects with COPD. Subjects are scored on eight items (cough, phlegm, chest tightness, breathlessness, activity limitation, confidence, sleep and energy) on a scale of 0-5 depending on their impact. The sum of scores for each item gives the subject's impact score ranging from 0 (no impact) to 40 (worst possible impact).
Measured: 12 weeks
change from baseline in real distance walked for 6 minutes
Measured: 12 weeks
Secondary outcomes (6)
change from baseline in Physical activity
Physical activity will be assessed with the daily walking distance monitored by the application and wearable device.
Measured: 12 weeks
subject satisfaction with health status
changed from baseline in EQ-5D-5L
Measured: 12 weeks
subject satisfaction with service
Assessment tool: Patient's Global Assessment - Subjects are scored on four items (general, easy-to-follow, helpful in exercise and Physical fitness ) on a scale of 1-5 depending on their satisfaction level. The sum of scores for each item will be used for assessement of the subject's satisfaction in the trial.
Measured: 12 weeks
change in Healthcare resource utilisation(the number of hospitalization) in COPD(chronic obstructive pulmonary disease) Patients
Comparison with the number of hospitalization during the same period last year
Measured: 12 weeks
change in Healthcare resource utilisation(hospitalization period) in COPD(chronic obstructive pulmonary disease) Patients
Comparison with hospitalization period during the same period last year
Measured: 12 weeks
change in Healthcare resource utilisation(the number of visiting emergency room) in COPD(chronic obstructive pulmonary disease) Patients
Comparison with the number of visiting emergency room during the same period last year
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start15 May 2017
- Primary completion28 Dec 2017
- Study completion6 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The subjets were randomized(1:1:1) to 3 group(A: Fixed respiratory rehabilitation program group, B: Mixed respiratory rehabilitation program group( Fixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks) and C: Control group(Ordinary rehabilitation service of the site).
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Trade, Industry and Energy, Lifesemantics Corp.
- Responsible party
- Principal investigator, Chang-Min Choi, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432117
- Sponsor's protocol ID
- C2016-00568
- Status last verified
- Feb 2018
- First submitted
- 22 Jan 2018
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
PubMed 33511633Kwon H, Lee S, Jung EJ, Kim S, Lee JK, Kim DK, Kim TH, Lee SH, Lee MK, Song S, Shin K. An mHealth Management Platform for Patients with Chronic Obstructive Pulmonary Disease (efil breath): Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Aug 24;6(8):e10502. doi: 10.2196/10502.
PubMed 30143475
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Clinical Trial to Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases
- ClinicalTrials.gov ID
- NCT03432117
- Acronym / sponsor ID
- C2016-00568
- Conditions
- Respiratory Disease, Lung Cancer, COPD
- Keywords
- respiratory rehabilitation, personalized mobile services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Trade, Industry and Energy, Lifesemantics Corp.
- Study start
- 15 May 2017 (actual)
- Primary completion
- 28 Dec 2017 (actual)
- Study completion
- 6 Jan 2018 (actual)
- First posted
- 14 Feb 2018 (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.
This trial is multicenter prospective study to evaluate clinical efficacy of respiratory rehabilitation personalized mobile services for respiratory disease.
Detailed description
Patients with Lung Cancer or COPD who need respiratory rehabilitation were enrolled in this trial. The subjets were randomized to 3 group(A: Fixed respiratory rehabilitation program group, B: Mixed respiratory rehabilitation program group(Fixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks) and C: Control group(Ordinary rehabilitation service of the site)).
Patients in Group A\&B were provided with mobile application and wearable O2 saturation machine and mobile application monitors physical activity and provides
- how to do stretching, weight training with The-ra Band
- daily and weekly target of exercise
- alarm algorithms depending on patient's respiratory status(purse rate and O2 saturation)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The subjets were randomized(1:1:1) to 3 group(A: Fixed respiratory rehabilitation program group, B: Mixed respiratory rehabilitation program group( Fixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks) and C: Control group(Ordinary rehabilitation service of the site).
| Arm | Type | Receives |
|---|---|---|
| Fixed respiratory rehabilitation program(A) | Experimental | Other: Fixed respiratory rehabilitationrespiratory rehabilitation program for 12 weeks |
| Mixed respiratory rehabilitation program(B) | Experimental | Other: Fixed respiratory rehabilitation, Other: Responsive respiratory rehabilitationFixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks |
| Control(C) | No intervention | –Ordinary rehabilitation service of the site for 12 weeks |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with Lung cancer or COPD
- Patients with FEV1<80% or FVC<80% in Pulmonary function test
- The distance walked for 6 minutes in 6-minute walk test ≥ 150 m
- Patients with android phone
- Patients who voluntarily agree to study participation and provide written informed consent form
Key exclusion criteria (5 listed)
- Patients with diseases which could be cause of death or significant disability for 1 year after study enrollment.
- Patients with diseases that are difficult to walk or improve walking at screening
- Patients with significant diseases which are difficult to include in this study in accordance with the investigator's judgment
- Patients who are illiterate or have communication limitations
- Patients who have a difficulty to complete a questionnaire or are uncooperative due to deterioration of recognition function
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 |
|---|---|---|
| Fixed respiratory rehabilitationThere are 6 step-exercise presented in the application and initial target of exercise will be set according to subject condition. After subject completes targeted exercise, next step will be started. | Other | Fixed respiratory rehabilitation program(A), Mixed respiratory rehabilitation program(B) |
| Responsive respiratory rehabilitationThe application provide responsive exercise program by changing type and numbers of exercise according to subject condition and exercise ability (This will be assessed with monitored O2 saturation, symptom of dyspnea and pulse rate during exercise) | Other | Mixed respiratory rehabilitation program(B) |
Primary outcome
change from baseline in Modified Medical Research Council dyspnea score
Time frame: 12 weeks
The MMRC dyspnea scale is a five-option grading system. The scale measures a person's limitation base on a scale of 0-4 and uses the final value to determine how much disability is caused by shortness of breath.
change from baseline in COPD Assessment Test(CAT) score
Time frame: 12 weeks
The CAT is a validated, short and simple subject completed questionnaire which has been developed for use in routine clinical practice to measure the health status of subjects with COPD. Subjects are scored on eight items (cough, phlegm, chest tightness, breathlessness, activity limitation, confidence, sleep and energy) on a scale of 0-5 depending on their impact. The sum of scores for each item gives the subject's impact score ranging from 0 (no impact) to 40 (worst possible impact).
change from baseline in real distance walked for 6 minutes
Time frame: 12 weeks
6 secondary outcomes
change from baseline in Physical activity
Time frame: 12 weeks
subject satisfaction with health status
Time frame: 12 weeks
subject satisfaction with service
Time frame: 12 weeks
change in Healthcare resource utilisation(the number of hospitalization) in COPD(chronic obstructive pulmonary disease) Patients
Time frame: 12 weeks
change in Healthcare resource utilisation(hospitalization period) in COPD(chronic obstructive pulmonary disease) Patients
Time frame: 12 weeks
change in Healthcare resource utilisation(the number of visiting emergency room) in COPD(chronic obstructive pulmonary disease) Patients
Time frame: 12 weeks
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 28 Feb 2018.
- Derived from this study: PubMed 33511633Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
- Derived from this study: PubMed 30143475Kwon H, Lee S, Jung EJ, Kim S, Lee JK, Kim DK, Kim TH, Lee SH, Lee MK, Song S, Shin K. An mHealth Management Platform for Patients with Chronic Obstructive Pulmonary Disease (efil breath): Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Aug 24;6(8):e10502. doi: 10.2196/10502.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed respiratory rehabilitation and Responsive respiratory rehabilitation in people with Respiratory Disease and Lung Cancer, run by Asan Medical Center at 5 sites in South Korea.
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 7 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: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. 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. 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?
change from baseline in Modified Medical Research Council dyspnea score (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03432117, which also lists 2 linked publications.
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 28 Feb 2018.