Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases

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

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

Study Overview

• Status: Completed
• Conditions: Lung Cancer; COPD; Respiratory Disease
• Intervention / Treatment: Other: Fixed respiratory rehabilitation; Other: Responsive respiratory rehabilitation

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)

• Study Type: Interventional
• Enrollment (Actual): 179
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 07061
    • SMG-SNU Boramae Medical Center
  • Seoul, Korea, Republic of, 02447
    • Kyunghee University Medical Center
  • Gangwon-do
    • Wonju, Gangwon-do, Korea, Republic of, 26426
      • Wonju Severance Christian Hospital
  • Gyeonggi-do
    • Guri-si, Gyeonggi-do, Korea, Republic of, 11923
      • Hanyang University Guri Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Ministry of Trade, Industry and Energy; Lifesemantics Corp.

Publications and helpful links

General Publications

• Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
• Kwon H, Lee S, Jung EJ, Kim S, Lee JK, Kim DK, Kim TH, Lee SH, Lee MK, Song S, Shin K. An mHealth Management Platform for Patients with Chronic Obstructive Pulmonary Disease (efil breath): Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Aug 24;6(8):e10502. doi: 10.2196/10502.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Actual): December 28, 2017
• Study Completion (Actual): January 6, 2018

Study Registration Dates

• First Submitted: January 22, 2018
• First Submitted That Met QC Criteria: February 7, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: respiratory rehabilitation; personalized mobile services
• Additional Relevant MeSH Terms: Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: C2016-00568

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No