Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-01-06 @ 6:13 AM
Study NCT ID:
NCT03704493
Status:
COMPLETED
Last Update Posted:
2018-10-12
First Post:
2018-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Group Motivation in Exercise Treadmill Testing
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The intervention consists of a video shown to the patient while exercising on the treadmill. It shows 5 amateur runners running across woods and fields. The group is film form behind giving the patient the impression of running within the group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2014-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2018-09-10', 'studyFirstSubmitQcDate': '2018-10-10', 'lastUpdatePostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patients' performance", 'timeFrame': 'Day of Exercise Testing', 'description': "Patients' performance in metabolic equivalents percentage of age predicted maximum"}, {'measure': "Patients' comfort", 'timeFrame': 'Day of Exercise Testing', 'description': 'Subjective level of comfort of patient during the exercise test rated on a 10 point scale. Scale ranges from 1 to 10. 10 indicates that the patient felt absolutely comfortable during the test, 1 indicates that the patient did not feel comfortable at all.'}], 'secondaryOutcomes': [{'measure': 'Exercise test duration', 'timeFrame': 'Day of Exercise Testing', 'description': 'Exercise test duration in min:sec'}, {'measure': 'Age predicted heart rate', 'timeFrame': 'Day of Exercise Testing', 'description': 'achieved percentage of age predicted heart rate'}, {'measure': 'physical limits', 'timeFrame': 'Day of Exercise Testing', 'description': 'Achieved subjective level of physical limit rated on a 10 point scale. Scale ranges from 1 to 10, 10 indicates that the patient subjectively reached his physical Limit, 1 indicates that the patient did not reach his physical limit at all. The higher the value the more did the patient reach his physical limit (the better the outcome).'}, {'measure': 'rate pressure product increase', 'timeFrame': 'Day of Exercise Testing', 'description': 'increase of the rate pressure product during the test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise testing', 'coronary artery disease', 'virtual group motivation'], 'conditions': ['Exercise Test']}, 'referencesModule': {'references': [{'pmid': '32725609', 'type': 'DERIVED', 'citation': 'Wilzeck VC, Hufschmid J, Bischof L, Hansi C, Nagele MP, Beer JH, Hufschmid U. A significant increase in exercise test performance with virtual group motivation: a randomised open-label controlled trial. Swiss Med Wkly. 2020 Jul 15;150:w20287. doi: 10.4414/smw.2020.20287. eCollection 2020 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'Exercise stress testing is the most frequently used clinical tool for assessment of coronary artery disease. To ensure a high validity of the results, a good Patient compliance is crucial. The aim of this study is to examine the effects of a virtually presented exercise group on the perceived comfort and the exercise capacity of patients during classical treadmill exercise testing. The investigators hypothesis is, that a virtually presented running group will increase the comfort of patients and their exercise capacity.', 'detailedDescription': '108 Patients were randomized in an open label trial 1:1 to either exercise treadmill testing while watching a static image of a flower (image group) or to exercise treadmill testing while watching a video of 5 amateur runners, running across and fields, giving the patient the impression of running within the group (video group). After the exercise test patients were asked to score their perceived comfort level and achieved level of their subjective physical limit on a 10 point scale.\n\nStandard exercise treadmill parameters, as well as baseline demographic data were recorded of each patient. Patients with missing data was excluded of the analysis.\n\nStatistic analysis was performed with t-test for normally distributed data and Wilcoxon-Mann-Whitney-Test for non-normal data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indication for exercise stress testing\n\nExclusion Criteria:\n\n* any contraindication for exercise stress testing\n* unability of performing an exercise treadmill test\n* recent surgery'}, 'identificationModule': {'nctId': 'NCT03704493', 'briefTitle': 'Virtual Group Motivation in Exercise Treadmill Testing', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Baden'}, 'officialTitle': 'The Impact of Virtual Group Motivation on the Performance and Comfort of Patients in Exercise Treadmill Testing: A Randomized, Open Label Trial', 'orgStudyIdInfo': {'id': 'ErgoTrial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Image Group', 'description': 'The patients were looking at a static image of a lavender flower while exercising on the treadmill.'}, {'type': 'EXPERIMENTAL', 'label': 'Video Group', 'description': 'The patients were watching a video of a group of amateur runners while exercising on the treadmill.', 'interventionNames': ['Diagnostic Test: Video Group']}], 'interventions': [{'name': 'Video Group', 'type': 'DIAGNOSTIC_TEST', 'description': 'A video of a group of five amateur runners running along woods and fields. The group was filmed from behind to give the patient the impression of running within the group.', 'armGroupLabels': ['Video Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jürg Hans Beer, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of the Department of Internal Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Baden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Cardiology, Principal Investigator', 'investigatorFullName': 'Urs Hufschmid', 'investigatorAffiliation': 'Kantonsspital Baden'}}}}