Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases

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

Detailed Description
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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)

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

Conditions
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Respiratory Disease, Lung Cancer, COPD

Intervention / Treatment
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* Other: Fixed respiratory rehabilitation
* Other: Responsive respiratory rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixed respiratory rehabilitation program(A)<br>respiratory rehabilitation program for 12 weeks | Other: Fixed respiratory rehabilitation<br>* 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.<br>|
| Experimental: Mixed respiratory rehabilitation program(B)<br>Fixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks | Other: Fixed respiratory rehabilitation<br>* 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.<br>Other: Responsive respiratory rehabilitation<br>* 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)<br>|
| No Intervention: Control(C)<br>Ordinary rehabilitation service of the site for 12 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| change from baseline in real distance walked for 6 minutes |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| subject satisfaction with health status | changed from baseline in EQ-5D-5L | 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. | 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 | 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 | 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 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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respiratory rehabilitation, personalized mobile services