COPD, Lung Cancer, Respiratory Disease
Conditions
Keywords
respiratory rehabilitation, personalized mobile services
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)
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)
Sponsors
Ministry of Trade, Industry and Energy
Lifesemantics Corp.
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline in Modified Medical Research Council dyspnea score | 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 | 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 | 12 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in Healthcare resource utilisation(the number of hospitalization) in COPD(chronic obstructive pulmonary disease) Patients | 12 weeks | Comparison with the number of hospitalization during the same period last year |
| change from baseline in Physical activity | 12 weeks | Physical activity will be assessed with the daily walking distance monitored by the application and wearable device. |
| change in Healthcare resource utilisation(the number of visiting emergency room) in COPD(chronic obstructive pulmonary disease) Patients | 12 weeks | Comparison with the number of visiting emergency room during the same period last year |
| change in Healthcare resource utilisation(hospitalization period) in COPD(chronic obstructive pulmonary disease) Patients | 12 weeks | Comparison with hospitalization period during the same period last year |
| subject satisfaction with health status | 12 weeks | changed from baseline in EQ-5D-5L |
| subject satisfaction with service | 12 weeks | 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. |
Countries
South Korea
Outcome results
None listed