Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-05 @ 2:36 AM
Study NCT ID:
NCT05383950
Status:
UNKNOWN
Last Update Posted:
2022-05-26
First Post:
2022-05-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitation of Chronic Diseases and Smart Health Management System Service
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-20', 'studyFirstSubmitDate': '2022-05-01', 'studyFirstSubmitQcDate': '2022-05-18', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of 6 minutes walk distance at 12 weeks (Chronic respiratory disease group)', 'timeFrame': '12 weeks', 'description': 'The distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.'}, {'measure': 'change of maximal oxygen consumption (VO2max) at 12 weeks (Chronic respiratory disease group, Chronic cardiac disease group)', 'timeFrame': '12 weeks', 'description': 'The maximum rate of oxygen consumption measured during incremental exercise test (cardiopulmonary exercise test).'}, {'measure': 'change of frailty index at 12 weeks (Chronic geriatric disease group)', 'timeFrame': '12 weeks', 'description': 'The frailty index is defined as the proportion of deficits present in an individual out of the total number of age-related health variables considered.\n\nFrailty Index (FI) = (number of health deficits present) ÷ (number of health deficits measured)\n\nFor example, a person with 20 of 40 deficits collected has an FI score of 20/40 = 0.5\n\nThe frailty index ranges 0 (best performance) to 1 (worst performance).'}], 'secondaryOutcomes': [{'measure': 'change from dyspnea symptom at 12 weeks (Chronic respiratory disease group, Chronic geriatric disease group)', 'timeFrame': '12 weeks', 'description': 'Dyspnea symptom is measured according to the Modified Medical Research Council (mMRC) Dyspnea Scale.\n\nThe mMRC scale is from 0 to 4:\n\n0, no breathlessness except on strenuous exercise\n\n1. shortness of breath when hurrying on the level or walking up a slight hill\n2. walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level\n3. stops for breath after walking ∼100 m or after few minutes on the level\n4. too breathless to leave the house, or breathless when dressing or undressing'}, {'measure': 'change from dyspnea symptom at 12 weeks (Chronic cardiac disease group, Chronic geriatric disease group)', 'timeFrame': '12 weeks', 'description': 'Dyspnea symptom is measured according to the New York Heart Association Functional Classification (NYHA class).\n\nThe NYHA class is from I to IV:\n\nClass I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation (feeling heart beats), or dyspnea (shortness of breath).\n\nClass II(Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.\n\nClass III(Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.\n\nClass IV(Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.'}, {'measure': 'Change of EuroQol 5-dimension 5-level (EQ-5D-5L) score at 12 weeks (all groups)', 'timeFrame': '12 weeks', 'description': 'A questionnaire assessing health related quality of life on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each item is scored 1-5, yielding a total between 5 and 25.\n\nThe scores range from 5 (best performance) to 25 (worst performance).'}, {'measure': 'change of Korean Health-related Quality of Life Instrument with 8 Items (HINT-8) score at 12 weeks (all groups)', 'timeFrame': '12 weeks', 'description': 'A questionnaire assessing health related quality of life on 4 health dimensions (physical, mental, social, positive health dimension). Each item is scored 1-4, yielding a total between 8 and 40.\n\nThe scores range from 8 (best performance) to 40 (worst performance).'}, {'measure': 'change of muscle strength at 12 weeks (all groups)', 'timeFrame': '12 weeks', 'description': 'The muscle strength measures hand grip strength. The cut-off value for sarcopenia is \\< 30 kg'}, {'measure': 'change of Short physical performance battery (SPPB) at 12 weeks (all groups)', 'timeFrame': '12 weeks', 'description': 'The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons.\n\nThe scores range from 0 (worst performance) to 12 (best performance). The cut off value for sarcopenia is ≤ 8.'}, {'measure': 'change of muscle mass at 12 weeks (all groups)', 'timeFrame': '12 weeks', 'description': 'The muscle mass is measured using the Bioelectrical Impedance Analysis. The cut off value for sarcopenia is \\< 7.26 kg/m\\^2.'}, {'measure': 'change of forced expiratory volume in one second (FEV1) at 12 weeks (Chronic respiratory disease group)', 'timeFrame': '12 weeks', 'description': 'The forced expiratory volume in one second (FEV1) is measured using spirometry. The value will be presented in % predicted value.'}, {'measure': 'change of forced vital capacity (FVC) at 12 weeks (Chronic respiratory disease group)', 'timeFrame': '12 weeks', 'description': 'The forced vital capacity (FVC) is measured using spirometry. The value will be presented in % predicted value.'}, {'measure': 'change of diffusing capacity of the lung for carbon monoxide (DLCO) at 12 weeks (Chronic respiratory disease group)', 'timeFrame': '12 weeks', 'description': 'The diffusing capacity of the lung for carbon monoxide (DLCO) is measured using single breath holding method.\n\nThe value will be presented in % predicted value.'}, {'measure': 'Change of chest pain symptom at 12 weeks (Chronic cardiac disease group)', 'timeFrame': '12 weeks', 'description': 'Chest pain symptom is measured according to the Canadian Cardiovascular Society grading of angina pectoris (CCS angina grade).\n\nThe CCS angina grade is from I to IV:\n\nGrade I: Angina with strenuous/rapid/prolonged exertion at work or recreation only; no angina with ordinary physical activity, e.g. walking, climbing stairs Grade II: Ordinary activity slightly limited: angina with walking/climbing stairs rapidly, walking uphill, walking or stair climbing after meals, in cold/wind, under emotional stress, during few hours after awakening, walking \\>2 blocks on level ground, or climbing \\>1 flight of stairs at normal pace and normal conditions Grade III: Marked limitation of ordinary physical activity: angina with walking 1-2 blocks on level ground or climbing 1 flight of stairs at normal pace and normal conditions Grade IV: Inability to carry on any physical activity without discomfort; anginal syndrome may be present at rest'}, {'measure': 'change of exercise duration in cardiopulmonary exercise test at 12 weeks (Chronic cardiac disease group)', 'timeFrame': '12 weeks', 'description': 'This test measures total exercise duration.'}, {'measure': 'change of exercise capacity in cardiopulmonary exercise test at 12 weeks (Chronic cardiac disease group)', 'timeFrame': '12 weeks', 'description': 'This test measures metabolic equivalents (METs).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Rehabilitation', 'Cardiac Rehabilitation']}, 'referencesModule': {'references': [{'pmid': '38321153', 'type': 'DERIVED', 'citation': 'Chung C, Kim AR, Kim D, Kwon H, Lee SH, Jang IY, Jo MW, Kang DY, Lee SW. Smartphone application-based rehabilitation in patients with chronic respiratory and cardiovascular diseases. Sci Rep. 2024 Feb 6;14(1):3018. doi: 10.1038/s41598-024-53583-2.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dyspnea symptom \\>= mMRC 1 or NYHA I\n* adults between 20 years and 80 or years\n\nChronic respiratory disease\n\n* FEV1/FVC \\< 0.7 in pulmonary function test\n* bronchiectasis in more than one lobe on chest computed tomography\n* FVC of DLCO \\< 0.8 of predicted value in pulmonary function test\n\nChronic cardiac disease\n\n* Reperfusion Therapy for angina pectoris or myocardial infarction\n* Heart failure with reduced ejection fraction (LVEF \\< 50%)\n\nChronic geriatric disease\n\n* Ages between 60 and 80 years\n* Clinical frailty scale between 1 and 4\n\nExclusion Criteria:\n\n* history of acute exacerbation within 4 weeks\n* unable to comply rehabilitation program\n* not suitable for study on decision by duty physician\n* no consent'}, 'identificationModule': {'nctId': 'NCT05383950', 'briefTitle': 'Rehabilitation of Chronic Diseases and Smart Health Management System Service', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Rehabilitation of Chronic Diseases and Smart Health Management System Service Provided by Hospital and Community Association', 'orgStudyIdInfo': {'id': '2022-0562'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'smartphone application based 12-week pulmonary or cardiac rehabilitation', 'interventionNames': ['Device: smartphone application']}], 'interventions': [{'name': 'smartphone application', 'type': 'DEVICE', 'description': 'In this study, the investigators will provide smartphone application based 12-week pulmonary or cardiac rehabilitation program to patients with chronic respiratory, cardiac, or geriatric diseases.', 'armGroupLabels': ['smartphone application based 12-week pulmonary or cardiac rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05505', 'city': 'Seoul', 'state': 'Songpa', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sei Won Lee, MD PhD', 'role': 'CONTACT', 'email': 'iseiwon@gmail.com', 'phone': '+82-2-3010-3990'}], 'facility': 'Asan Medical Center, University of Ulsan College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Sei Won Lee', 'investigatorAffiliation': 'Asan Medical Center'}}}}