Multicenter Prospective Clinical Trial to Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases

Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases

Sponsors

Lead sponsor: Asan Medical Center

Collaborator: Ministry of Trade, Industry and Energy
LifeSemantics Corp.

Source Asan Medical Center
Brief Summary

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

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)

Overall Status Completed
Start Date May 15, 2017
Completion Date January 6, 2018
Primary Completion Date December 28, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
change from baseline in Modified Medical Research Council dyspnea score 12 weeks
change from baseline in Modified Medical Research Council dyspnea score 12 weeks
change from baseline in Modified Medical Research Council dyspnea score 12 weeks
change from baseline in COPD Assessment Test(CAT) score 12 weeks
change from baseline in COPD Assessment Test(CAT) score 12 weeks
change from baseline in COPD Assessment Test(CAT) score 12 weeks
change from baseline in real distance walked for 6 minutes 12 weeks
change from baseline in real distance walked for 6 minutes 12 weeks
Secondary Outcome
Measure Time Frame
change from baseline in Physical activity 12 weeks
subject satisfaction with health status 12 weeks
subject satisfaction with service 12 weeks
change in Healthcare resource utilisation(the number of hospitalization) in COPD(chronic obstructive pulmonary disease) Patients 12 weeks
change in Healthcare resource utilisation(hospitalization period) in COPD(chronic obstructive pulmonary disease) Patients 12 weeks
change in Healthcare resource utilisation(the number of visiting emergency room) in COPD(chronic obstructive pulmonary disease) Patients 12 weeks
Enrollment 179
Condition
Intervention

Intervention type: Other

Intervention name: Fixed respiratory rehabilitation

Description: 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.

Intervention type: Other

Intervention name: Responsive respiratory rehabilitation

Description: 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)

Arm group label: Mixed respiratory rehabilitation program(B)

Eligibility

Criteria:

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

Gender: All

Minimum age: 20 Years

Maximum age: 80 Years

Healthy volunteers: No

Location
facility
Wonju Severance Christian Hospital
Hanyang University Guri Hospital
KyungHee University Medical Center
Asan Medical Center
Smg-Snu Boramae Medical Center
Location Countries

Korea, Republic of

Verification Date

February 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Asan Medical Center

Investigator full name: Chang-Min Choi

Investigator title: associate professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Fixed respiratory rehabilitation program(A)

Arm group type: Experimental

Description: respiratory rehabilitation program for 12 weeks

Arm group label: Mixed respiratory rehabilitation program(B)

Arm group type: Experimental

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

Arm group label: Control(C)

Arm group type: No Intervention

Description: Ordinary rehabilitation service of the site for 12 weeks

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention 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).

Primary purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov