Clinical trial NCT03432117: Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases
Official title: Multicenter Prospective Clinical Trial to Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Disease
Lung Cancer
COPD
Keywords: respiratory rehabilitation
personalized mobile services
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Ministry of Trade, Industry and Energy
name: Lifesemantics Corp.
First posted: 2018-02-14
Enrollment: 179
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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)

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

Primary outcomes:
measure: change from baseline in Modified Medical Research Council dyspnea score
timeFrame: 12 weeks
measure: change from baseline in COPD Assessment Test(CAT) score
timeFrame: 12 weeks
measure: change from baseline in real distance walked for 6 minutes
timeFrame: 12 weeks
Secondary outcomes:
measure: change from baseline in Physical activity
timeFrame: 12 weeks
measure: subject satisfaction with health status
timeFrame: 12 weeks
measure: subject satisfaction with service
timeFrame: 12 weeks
measure: change in Healthcare resource utilisation(the number of hospitalization) in COPD(chronic obstructive pulmonary disease) Patients
timeFrame: 12 weeks
measure: change in Healthcare resource utilisation(hospitalization period) in COPD(chronic obstructive pulmonary disease) Patients
timeFrame: 12 weeks
measure: change in Healthcare resource utilisation(the number of visiting emergency room) in COPD(chronic obstructive pulmonary disease) Patients
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon-do
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: KyungHee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Smg-Snu Boramae Medical Center
Study officials:
References:
citation: 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.
citation: 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.