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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03432117
Other study ID # C2016-00568
Secondary ID
Status Completed
Phase N/A
First received January 22, 2018
Last updated February 27, 2018
Start date May 15, 2017
Est. completion date January 6, 2018

Study information

Verified date February 2018
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is multicenter prospective study to evaluate clinical efficacy of respiratory rehabilitation personalized mobile services for respiratory disease.


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)


Recruitment information / eligibility

Status Completed
Enrollment 179
Est. completion date January 6, 2018
Est. primary completion date December 28, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- 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

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

Study Design


Intervention

Other:
Fixed 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.
Responsive 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)

Locations

Country Name City State
Korea, Republic of Hanyang University Guri Hospital Guri-si Gyeonggi-do
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of KyungHee University Medical Center Seoul
Korea, Republic of Smg-Snu Boramae Medical Center Seoul
Korea, Republic of Wonju Severance Christian Hospital Wonju Gangwon-do

Sponsors (3)

Lead Sponsor Collaborator
Asan Medical Center LifeSemantics Corp., Ministry of Trade, Industry and Energy

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 weeks
Primary 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). 12 weeks
Primary change from baseline in real distance walked for 6 minutes 12 weeks
Secondary change from baseline in Physical activity Physical activity will be assessed with the daily walking distance monitored by the application and wearable device. 12 weeks
Secondary subject satisfaction with health status changed from baseline in EQ-5D-5L 12 weeks
Secondary 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. 12 weeks
Secondary 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 12 weeks
Secondary change in Healthcare resource utilisation(hospitalization period) in COPD(chronic obstructive pulmonary disease) Patients Comparison with hospitalization period during the same period last year 12 weeks
Secondary 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 12 weeks
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