Clinical trial NCT05383950: Rehabilitation of Chronic Diseases and Smart Health Management System Service
Official title: Rehabilitation of Chronic Diseases and Smart Health Management System Service Provided by Hospital and Community Association
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Rehabilitation
Cardiac Rehabilitation
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: In Republic of Korea, it is not easy to practice standard pulmonary rehabilitation (PR) or cardiac rehabilitation (CR). In this study, the investigators will provide newly developed smartphone application to patients with chronic respiratory, cardiac, or geriatric diseases. The investigators want to confirm whether participants, who perform smartphone application based 12-week PR or CR program, present improved exercise capacity, dyspnea symptom, muscle strength, or quality of life.


Eligibility criteria: Inclusion Criteria:

* Dyspnea symptom \>= mMRC 1 or NYHA I
* adults between 20 years and 80 or years

Chronic respiratory disease

* FEV1/FVC \< 0.7 in pulmonary function test
* bronchiectasis in more than one lobe on chest computed tomography
* FVC of DLCO \< 0.8 of predicted value in pulmonary function test

Chronic cardiac disease

* Reperfusion Therapy for angina pectoris or myocardial infarction
* Heart failure with reduced ejection fraction (LVEF \< 50%)

Chronic geriatric disease

* Ages between 60 and 80 years
* Clinical frailty scale between 1 and 4

Exclusion Criteria:

* history of acute exacerbation within 4 weeks
* unable to comply rehabilitation program
* not suitable for study on decision by duty physician
* no consent

Primary outcomes:
measure: change of 6 minutes walk distance at 12 weeks (Chronic respiratory disease group)
timeFrame: 12 weeks
measure: change of maximal oxygen consumption (VO2max) at 12 weeks (Chronic respiratory disease group, Chronic cardiac disease group)
timeFrame: 12 weeks
measure: change of frailty index at 12 weeks (Chronic geriatric disease group)
timeFrame: 12 weeks
Secondary outcomes:
measure: change from dyspnea symptom at 12 weeks (Chronic respiratory disease group, Chronic geriatric disease group)
timeFrame: 12 weeks
measure: change from dyspnea symptom at 12 weeks (Chronic cardiac disease group, Chronic geriatric disease group)
timeFrame: 12 weeks
measure: Change of EuroQol 5-dimension 5-level (EQ-5D-5L) score at 12 weeks (all groups)
timeFrame: 12 weeks
measure: change of Korean Health-related Quality of Life Instrument with 8 Items (HINT-8) score at 12 weeks (all groups)
timeFrame: 12 weeks
measure: change of muscle strength at 12 weeks (all groups)
timeFrame: 12 weeks
measure: change of Short physical performance battery (SPPB) at 12 weeks (all groups)
timeFrame: 12 weeks
measure: change of muscle mass at 12 weeks (all groups)
timeFrame: 12 weeks
measure: change of forced expiratory volume in one second (FEV1) at 12 weeks (Chronic respiratory disease group)
timeFrame: 12 weeks
measure: change of forced vital capacity (FVC) at 12 weeks (Chronic respiratory disease group)
timeFrame: 12 weeks
measure: change of diffusing capacity of the lung for carbon monoxide (DLCO) at 12 weeks (Chronic respiratory disease group)
timeFrame: 12 weeks
measure: Change of chest pain symptom at 12 weeks (Chronic cardiac disease group)
timeFrame: 12 weeks
measure: change of exercise duration in cardiopulmonary exercise test at 12 weeks (Chronic cardiac disease group)
timeFrame: 12 weeks
measure: change of exercise capacity in cardiopulmonary exercise test at 12 weeks (Chronic cardiac disease group)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, University of Ulsan College of Medicine
state: Songpa
Study officials:
References: