Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03432117
• Other study ID #: C2016-00568
• 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
• 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

Related Conditions & MeSH terms

• COPD
• Lung Cancer
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

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