Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-13 @ 7:51 AM
Study NCT ID:
NCT05616858
Status:
UNKNOWN
Last Update Posted:
2023-08-15
First Post:
2022-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complex Exercise Program for Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, open-label, case-control study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-13', 'studyFirstSubmitDate': '2022-10-31', 'studyFirstSubmitQcDate': '2022-11-07', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak VO2', 'timeFrame': 'Baseline evaluation', 'description': 'Maximal VO2 from cardiopulmonary exercise test'}, {'measure': 'Peak VO2', 'timeFrame': 'Follow-up evaluation (through study completion, an average of 6 weeks)', 'description': 'Maximal VO2 from cardiopulmonary exercise test'}], 'secondaryOutcomes': [{'measure': 'Functional ambulation category (0-5, the higher the better)', 'timeFrame': 'Baseline evaluation', 'description': '6-point functional walking test that evaluates ambulation ability'}, {'measure': 'Functional ambulation category (0-5, the higher the better)', 'timeFrame': 'Follow-up evaluation (through study completion, an average of 6 weeks)', 'description': '6-point functional walking test that evaluates ambulation ability'}, {'measure': 'Berg balance scale (0-56, the higher the better)', 'timeFrame': 'Baseline evaluation', 'description': "Objectively determine a patient's ability to safely balance during a series of predetermined tasks"}, {'measure': 'Berg balance scale (0-56, the higher the better)', 'timeFrame': 'Follow-up evaluation (through study completion, an average of 6 weeks)', 'description': "Objectively determine a patient's ability to safely balance during a series of predetermined tasks"}, {'measure': 'Timed up and go', 'timeFrame': 'Baseline evaluation', 'description': 'To determine fall risk and measure the progress of balance'}, {'measure': 'Timed up and go', 'timeFrame': 'Follow-up evaluation (through study completion, an average of 6 weeks)', 'description': 'To determine fall risk and measure the progress of balance'}, {'measure': 'Grip strength', 'timeFrame': 'Baseline evaluation', 'description': "measure of muscular strength or the maximum force/tension generated by one's forearm muscles"}, {'measure': 'Grip strength', 'timeFrame': 'Follow-up evaluation (through study completion, an average of 6 weeks)', 'description': "measure of muscular strength or the maximum force/tension generated by one's forearm muscles"}, {'measure': '6-minute walk test', 'timeFrame': 'Baseline evaluation', 'description': 'practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians'}, {'measure': '6-minute walk test', 'timeFrame': 'Follow-up evaluation (through study completion, an average of 6 weeks)', 'description': 'practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians'}, {'measure': 'Figure-of-eight walk test', 'timeFrame': 'Baseline evaluation', 'description': 'Measurement tool that assesses the ability to walk on a curved path'}, {'measure': 'Figure-of-eight walk test', 'timeFrame': 'Follow-up evaluation (through study completion, an average of 6 weeks)', 'description': 'Measurement tool that assesses the ability to walk on a curved path'}, {'measure': 'Sit-and-reach test', 'timeFrame': 'Baseline evaluation', 'description': 'Measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles'}, {'measure': 'Sit-and-reach test', 'timeFrame': 'Follow-up evaluation (through study completion, an average of 6 weeks)', 'description': 'Measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles'}, {'measure': 'Chair sit-to-stand test', 'timeFrame': 'Baseline evaluation', 'description': 'Testing leg strength and endurance in older adults'}, {'measure': 'Chair sit-to-stand test', 'timeFrame': 'Follow-up evaluation (through study completion, an average of 6 weeks)', 'description': 'Testing leg strength and endurance in older adults'}, {'measure': 'Fugl-Meyer assessment (0-226, the higher the better)', 'timeFrame': 'Baseline evaluation', 'description': 'Stroke-specific, performance-based impairment index'}, {'measure': 'Fugl-Meyer assessment (0-226, the higher the better)', 'timeFrame': 'Follow-up evaluation (through study completion, an average of 6 weeks)', 'description': 'Stroke-specific, performance-based impairment index'}, {'measure': 'Manual function test (0-32, the higher the better)', 'timeFrame': 'Baseline evaluation', 'description': 'Evaluate unilateral manual performance in hemiparetic patients after stroke'}, {'measure': 'Manual function test (0-32, the higher the better)', 'timeFrame': 'Follow-up evaluation (through study completion, an average of 6 weeks)', 'description': 'Evaluate unilateral manual performance in hemiparetic patients after stroke'}, {'measure': 'Modified Barthel Index (Korean version) (0-100, the higher the better)', 'timeFrame': 'Baseline evaluation', 'description': 'Measure of physical disability used widely to assess behaviour relating to activities of daily living'}, {'measure': 'Modified Barthel Index (Korean version) (0-100, the higher the better)', 'timeFrame': 'Follow-up evaluation (through study completion, an average of 6 weeks)', 'description': 'Measure of physical disability used widely to assess behaviour relating to activities of daily living'}, {'measure': 'Body composition analysis', 'timeFrame': 'Baseline evaluation', 'description': 'Percentage of fat, bone, and muscle in the body'}, {'measure': 'Body composition analysis', 'timeFrame': 'Follow-up evaluation (through study completion, an average of 6 weeks)', 'description': 'Percentage of fat, bone, and muscle in the body'}, {'measure': 'Korean Mini-Mental Status Examination (K-MMSE) (0-30, the higher the better)', 'timeFrame': 'Baseline evaluation', 'description': 'Screening of dementia and to investigate the possible changes of optimal cutoff scores'}, {'measure': 'Korean Mini-Mental Status Examination (K-MMSE) (0-30, the higher the better)', 'timeFrame': 'Follow-up evaluation (through study completion, an average of 6 weeks)', 'description': 'Screening of dementia and to investigate the possible changes of optimal cutoff scores'}, {'measure': 'Euro-Quality of Life-5 Dimension (EQ-5D) (5-25, the higher the better)', 'timeFrame': 'Baseline evaluation', 'description': 'A brief and simple instrument measuring health related quality of life'}, {'measure': 'Euro-Quality of Life-5 Dimension (EQ-5D) (5-25, the higher the better)', 'timeFrame': 'Follow-up evaluation (through study completion, an average of 6 weeks)', 'description': 'A brief and simple instrument measuring health related quality of life'}, {'measure': 'Getriatic depression scale (0-15, the higher the more depressive)', 'timeFrame': 'Baseline evaluation', 'description': 'Assessment of depression in the elderly'}, {'measure': 'Getriatic depression scale (0-15, the higher the more depressive)', 'timeFrame': 'Follow-up evaluation (through study completion, an average of 6 weeks)', 'description': 'Assessment of depression in the elderly'}, {'measure': 'International Physical Activity Questionnaire (No scores)', 'timeFrame': 'Baseline evaluation', 'description': '27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old'}, {'measure': 'International Physical Activity Questionnaire (No scores)', 'timeFrame': 'Follow-up evaluation (through study completion, an average of 6 weeks)', 'description': '27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Sports Physical Therapy', 'Program, Communication']}, 'descriptionModule': {'briefSummary': 'The physical and social effects of exercise programs and daily exercise have already been demonstrated in stroke. However, stroke survivors have shown a passive attitude towards the exercise program and there was little guideline and experience of the stroke exercise program in the community. Therefore, the study provides patients with an adequate guide to a complex exercise program after discharge based on the medical records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Community indwelling stroke patients discharged from Pusan National University Yangsan Hospital\n* Independent ambulator (FAC over 4)\n* Independent daily activities (Modified Rankin Scale less than 2)\n* No apparent spasticity on hemiplegic side (Modified Ashworth scale less than 1)\n* Hemiplegic side motor grades (Manual muscle testing, MMT) more than 3\n\nExclusion Criteria:\n\n* MMSE less than 18\n* BBS less than 41\n* Severe aphagia who cannot communicate\n* Severe cardiovascular conditions inhibiting exercise programs\n* Musculoskeletal problems inhibiting exercise programs\n* Other medical conditions considered by physiatrists'}, 'identificationModule': {'nctId': 'NCT05616858', 'acronym': 'CEPS', 'briefTitle': 'Complex Exercise Program for Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Pusan National University Yangsan Hospital'}, 'officialTitle': 'Safety and Cardiopulmonary Efficacy of Complex Exercise Program for Stroke Patients in the Community', 'orgStudyIdInfo': {'id': 'PNUYH_ETRI_2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Group with exercise program', 'interventionNames': ['Behavioral: Complex exercise program']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Group without exercise program'}], 'interventions': [{'name': 'Complex exercise program', 'type': 'BEHAVIORAL', 'description': 'Stretching exercise, aerobic exercise, strengthening and balancing exercise', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50612', 'city': 'Yangsan', 'state': 'Gyeongsangnam-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung-Hwa Ko, PhD', 'role': 'CONTACT', 'email': 'ijsh6679@gmail.com', 'phone': '+82-10-9344-4117'}], 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'centralContacts': [{'name': 'Sung-Hwa Ko, PhD', 'role': 'CONTACT', 'email': 'ijsh6679@gmail.com', 'phone': '+82-10-9344-4117'}, {'name': 'Sungchul Huh', 'role': 'CONTACT', 'email': 'dr.huhsc@gmail.com', 'phone': '+82-1093542177'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Sung-Hwa Ko', 'investigatorAffiliation': 'Pusan National University Yangsan Hospital'}}}}