ClinicalTrials.gg
CompletedNCT03432117Updated Feb 28, 2018

Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases

An interventional study of Fixed respiratory rehabilitation and Responsive respiratory rehabilitation in Respiratory Disease, Lung Cancer and COPD, sponsored by Asan Medical Center. Completed at 5 sites in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-02-28.

Sponsored by Asan Medical Center · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled May 2017, registered Jan 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
179
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Respiration Disorders with a site in Korea, Republic of — 1 open to participants now, 3 under way, 1 of them phase 3. Respiration Disorders · Korea, Republic of.

Enrollment
8th of 10
179 · median 232
Started
2017
with 3 others
No phase
2 of 13
none open now
Registered
5th of 13
by date
Lead sponsor
1 of 13
Asan Medical Center

Among the 13 studies in Respiration Disorders with a site in Korea, Republic of, this one is the 8th largest by enrollment of the 10 interventional ones that give a count, is one of 4 that started in 2017, is one of 2 with no phase, and was the 5th registered.

Respiration Disorders

359 studies on the registry are indexed under Respiration Disorders; 64 are open to participants now.

Browse Respiration Disorders studies →

Open to participants now

1 of the 13 studies in Respiration Disorders with a site in Korea, Republic of is open now. Recruiting first, the newest first:

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 45 Respiration Disorders studies recruiting now, 27 (60%) set no upper age limit and 13 (29%) stop at 75 or younger; 15 take children under 18; 21 take healthy volunteers.

This study: 20 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Respiration Disorders with a site in Korea, Republic of, or all of them as a file.
02

Study summary

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

  1. how to do stretching, weight training with The-ra Band
  2. daily and weekly target of exercise
  3. alarm algorithms depending on patient's respiratory status(purse rate and O2 saturation)
03

Conditions studied

  • Respiratory Disease
  • Lung Cancer
  • COPD

Keywords

  • respiratory rehabilitation
  • personalized mobile services
04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with Lung cancer or
  • Patients with \<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 form

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
179 participants (actual)

Study arms

  • Experimental
    Fixed respiratory rehabilitation program(A)

    respiratory rehabilitation program for 12 weeks

    Other: Fixed respiratory rehabilitation

  • Experimental
    Mixed respiratory rehabilitation program(B)

    Fixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks

    Other: Fixed respiratory rehabilitation · Other: Responsive respiratory rehabilitation

  • No intervention
    Control(C)

    Ordinary rehabilitation service of the site for 12 weeks

Interventions

  • OtherFixed respiratory rehabilitation

    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.

  • OtherResponsive respiratory rehabilitation

    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)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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).

    Time frame: 12 weeks

  3. change from baseline in real distance walked for 6 minutes

    Time frame: 12 weeks

Secondary outcomes

  1. change from baseline in Physical activity

    Physical activity will be assessed with the daily walking distance monitored by the application and wearable device.

    Time frame: 12 weeks

  2. subject satisfaction with health status

    changed from baseline in EQ-5D-5L

    Time frame: 12 weeks

  3. 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.

    Time frame: 12 weeks

  4. 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

    Time frame: 12 weeks

  5. change in Healthcare resource utilisation(hospitalization period) in COPD(chronic obstructive pulmonary disease) Patients

    Comparison with hospitalization period during the same period last year

    Time frame: 12 weeks

  6. 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

    Time frame: 12 weeks

07

Study locations

5 sites
  • Wonju Severance Christian Hospital
    Wonju, Gangwon-do 26426, Korea, Republic of
  • Hanyang University Guri Hospital
    Guri-si, Gyeonggi-do 11923, Korea, Republic of
  • KyungHee University Medical Center
    Seoul, 02447, Korea, Republic of
  • Asan Medical Center
    Seoul, 05505, Korea, Republic of
  • Smg-Snu Boramae Medical Center
    Seoul, 07061, Korea, Republic of
08

References and documents

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 33511633 ↗
  • Kwon 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2017 to primary completion in Dec 2017, 7 months.

Of 91 non-industry interventional studies with no phase under Respiration Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's 7 months is below that.

Counting every sponsor, half of 111 studies reached it within 18 months; a quarter within 7 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2018
First posted
Feb 14, 2018
StartActual
May 15, 2017
Primary completionActual
Dec 28, 2017
CompletionActual
Jan 6, 2018
Last update
Feb 28, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03432117
Collaborators
Ministry of Trade, Industry and Energy, Lifesemantics Corp.
Responsible party
Chang-Min Choi (associate professor, Asan Medical Center) — Principal investigator
First posted
Feb 14, 2018
Start date
May 15, 2017
Primary completion
Dec 28, 2017
Completion
Jan 6, 2018
Last update
Feb 28, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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