Clinical trial NCT05610358: Efficacy of Smartphone Application Based Rehabilitations in Patients With Chronic Respiratory or Cardiovascular Disease
Official title: Efficacy of Smartphone Application Based Rehabilitations in Patients With Chronic Respiratory or Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Rehabilitation
Cardiac Rehabilitation
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 162
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 or cardiovascular 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 II
* adults between 20 years and 80 or years

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

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

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 maximal oxygen consumption (VO2max)
timeFrame: 12 weeks
measure: Change of Chronic obstructive pulmonary disease (COPD) assessment Test (CAT) (Chronic respiratory disease group)
timeFrame: 12 weeks
measure: change of Korean Health-related Quality of Life Instrument with 8 Items (HINT-8) score (Chronic cardiovascular disease group)
timeFrame: 12 weeks
Secondary outcomes:
measure: change of dyspnea symptom (Chronic respiratory disease group)
timeFrame: 12 weeks
measure: change of dyspnea symptom (Chronic cardiovascular disease group)
timeFrame: 12 weeks
measure: Change of EuroQol 5-dimension 5-level (EQ-5D-5L) score
timeFrame: 12 weeks
measure: change of Korean Health-related Quality of Life Instrument with 8 Items (HINT-8) score (Chronic respiratory disease group)
timeFrame: 12 weeks
measure: change of hand grip strength
timeFrame: 12 weeks
measure: change of limb muscle mass
timeFrame: 12 weeks
measure: change of forced expiratory volume in one second (FEV1) (Chronic respiratory disease group)
timeFrame: 12 weeks
measure: change of forced vital capacity (FVC) (Chronic respiratory disease group)
timeFrame: 12 weeks
measure: change of diffusing capacity of the lung for carbon monoxide (DLCO) (Chronic respiratory disease group)
timeFrame: 12 weeks
measure: Change of chest pain symptom (Chronic cardiovascular disease group)
timeFrame: 12 weeks
measure: change of exercise duration in cardiopulmonary exercise test (Chronic cardiovascular disease group)
timeFrame: 12 weeks
measure: change of exercise capacity in cardiopulmonary exercise test (Chronic cardiovascular disease group)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: