Viewing Study NCT06525233


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Study NCT ID: NCT06525233
Status: COMPLETED
Last Update Posted: 2024-07-29
First Post: 2019-08-17
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Interval Aerobic Training and Continious Training
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'targetDuration': '6 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-24', 'studyFirstSubmitDate': '2019-08-17', 'studyFirstSubmitQcDate': '2024-07-24', 'lastUpdatePostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the effect of intermittent and continuous aerobic exercise on exercise capacity', 'timeFrame': '30 minutes 3 times a week during 6 weeks', 'description': 'we used the symptom-limited exercise test and six minute walking test (6DYT). All evaluation tests are done before and after training. Participants were into randomised two groups: interval aerobic training (AAE) and continuous aerobic training (SAE). Training lasted three times a week during 6 weeks. In both groups, significant changes were found in evaluation tests scores after the rehabilitation program (p\\<0,05). But only AAE group have important statistical difference comparing to SAE group on test time and 6DYT scores.'}], 'secondaryOutcomes': [{'measure': 'the effect of intermittent and continuous aerobic exercise on life quality', 'timeFrame': '30 minutes 3 times a week during 6 weeks', 'description': "The participants have no mental and physical disability to join in research. The participants' demographic infos and clinical story were recorded.We evaluate the life quality by using Short Form-36 (SF-36). All evaluation tests are done before and after training. Participants were into randomised two groups: interval aerobic training (AAE) and continuous aerobic training (SAE).After training SAE group showed significant statistical change in every SF-36 parameter, while AAE group showing significant values except energy/fatigue. AAE group have statistically significant changes comparing to SAE group on that parameters; physical function, role limitations due to physical function, role limitations due to emotional function and general health (p\\<0,05). Consequently AAE is much more tolerable comparing to SAE and AAE is considered more effective in increasing some parameters. On the other hand, we observed that both training types can be used in cardiac rehabilitation safely."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['continious training', 'interval training'], 'conditions': ['Coronary Artery Disease', 'Exercise Addiction']}, 'descriptionModule': {'briefSummary': "This research is comparing the effects of interval and continuous training which are the two types of aerobic training on persons' life quality and exercise capacity on coronary artery disease patients.", 'detailedDescription': "The participants are diagnosed coronary artery disease aged between 40- 80 and have no mental and physical disability to take part in research. The participants' demographic infos and clinical story were recorded. To evaluate exercise capacity we used the symptom-limited exercise test (ETT) and six minute walking test (6DYT). We evaluate the life quality by using Short Form-36 (SF-36).\n\nAll those evaluation tests are done before and after training. Participants are randomly divided into two groups, the first group took part in interval aerobic training (AAE) while the other group was joining in continuous training (SAE) three times a week during 6 weeks. In both groups, significant changes were found in ETT, test time and 6 DYT scores after the rehabilitation program (p\\<0,05). But only AAE group have important statistical values comparing to SAE group on test time and 6DYT scores. After training SAE group showed significant statistical change in every SF-36 parameter, while AAE group showing significant values except energy/fatigue. AAE group have statistically significant changes comparing to SAE group on that parameters; physical function, role limitations due to physical function, role limitations due to emotional function and general health (p\\<0,05). Consequently AAE is much more tolerable comparing to SAE and AAE is considered more effective in increasing some parameters. On the other hand, we observed that both training types can be used in cardiac rehabilitation safely."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Name-Surname, age, sex, body-weight index, educational status, married/single/divorced, job and clinical background (If has any surgery and myocardial infarction)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed coronary artery disease\n* aged between 40-80\n* over %55 ejection fraction\n\nExclusion Criteria:\n\n* mental and physical disability\n* unstable angina pectoris\n* thrombophlebitis'}, 'identificationModule': {'nctId': 'NCT06525233', 'briefTitle': 'Interval Aerobic Training and Continious Training', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'Comparision the Effect of Interval Aerobic Training and Continious Training on Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'aerobicexercise'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment', 'description': 'humans that diagnosed as coronary artery disease, joined two aerobic exercise groups. One of this group includes interval exercise and the other one includes continuous exercise.', 'interventionNames': ['Other: Physiotherapy and rehabilitation']}], 'interventions': [{'name': 'Physiotherapy and rehabilitation', 'type': 'OTHER', 'description': "The aerobic exercise is very crucial part of cardiac rehabilitation. This study compares the effects of interval and continuous training which are the two types of aerobic training on persons' life quality and exercise capacity diagnosed coronary artery disease patients.", 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Physiotherapy and Rehabilitation Center', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'overallOfficials': [{'name': 'Fatma Mutluay', 'role': 'STUDY_DIRECTOR', 'affiliation': 'medipol univercity'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': '2 years', 'ipdSharing': 'YES', 'description': 'Cardiac rehabilitation is very popular at nowadays and which type exercise good on cardiac rehabilitation is not known exactly', 'accessCriteria': 'karacaoglugulay@gmail.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'gulay karacaoglu', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}