Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-28 @ 4:35 AM
Study NCT ID:
NCT04299061
Status:
WITHDRAWN
Last Update Posted:
2022-03-24
First Post:
2020-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the Physical Activity Courses on the Physical Activity Level at University Students
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': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Due to the pandemic, sufficient number of participants could not be received.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2020-03-05', 'studyFirstSubmitQcDate': '2020-03-05', 'lastUpdatePostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Physical Activity Questionnaire', 'timeFrame': 'Baseline of the study', 'description': 'This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. Walking = 3.3 METs Moderate Intensity = 4.0 METs Vigorous Intensity = 8.0 METs Total MET-minutes/week = Walk (METs\\*min\\*days) + Mod (METs\\*min\\*days) + Vig (METs\\*min\\*days). 1. Low: • No activity is reported OR • Some activity is reported but not enough to meet Categories 2 or 3. 2. Moderate: • 3 or more days of vigorous activity of at least 20 minutes per day OR • 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR • 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-minutes/week. 3. High: • Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week'}, {'measure': 'Physical Activity Awareness Questionnaire - prepared by the researcher', 'timeFrame': 'Baseline of the study', 'description': 'It consists of 13 questions to assess the physical activity level awareness of students. The questionnaire was prepared by the researchers so it does not have a validation. Questions are about determined the difference between meanings of exercise and physical activity. For example:\n\nMark it as yes, no or not know.\n\n1. Physical activity and exercise mean the same thing.\n2. Physical activity is a subcategory of exercise.'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': 'Baseline of the study', 'description': 'The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.'}, {'measure': 'Perceived Stress Scale', 'timeFrame': 'Baseline of the study', 'description': 'The Perceived Stress Scale (PSS) is a 14-item self-report measure designed to assess "the degree to which situations in one\'s life are appraised as stressful. Each item is rated on a 5-point scale (0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, 4 = Very Often) and summed to create a total score. PSS-14 has strong internal consistency (α = .84 to .86) and good test-retest reliability (r = .85 over a 2-day period, r = .55 over a 6-week period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physical Activity Level', 'Physical Activity Awareness']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to evaluate the level of physical activity and awareness of physical activity among university students studying in a department other than health sciences and who have taken courses on "physical activity, exercise, healthy life".\n\nAccording to the results of the study, the perceptions of students from different departments on physical activity and exercise will be compared and the effects of the courses they have taken on students\' attitudes of daily physical activity will be examined.\n\nOur hypothesizes are:\n\n1 . A course such as an exercise, physical activity or wellness increases the awareness and physical activity level of students studying in different branches.\n\n2\\. Stress and sleep problems are less common among students who do regular physical activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '27 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteer to participate in the study\n* Being a student in departments of lawyer, engineering and architecture in university\n* Participation in courses is compulsory\n* For the study group; having taken physical activity, exercise, wellness classes as compulsory or optional in their university\n* For the control group; not taking physical activity, exercise, wellness lessons in their university\n\nExclusion Criteria:\n\n* Being a student in other departments'}, 'identificationModule': {'nctId': 'NCT04299061', 'briefTitle': 'Effect of the Physical Activity Courses on the Physical Activity Level at University Students', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Kültür University'}, 'officialTitle': 'The Effect of the Physical Activity and Healthy Living Elective Courses on Physical Activity Level and Awareness Among University Students Educating in Different Departments', 'orgStudyIdInfo': {'id': 'FASYD-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'interventionNames': ['Diagnostic Test: International Physical Activity Questionnaire', 'Diagnostic Test: Pittsburgh Sleep Quality Index', 'Other: Physical Activity Awareness Questionnaire - prepared by the researchers', 'Diagnostic Test: Perceived Stress Scale']}], 'interventions': [{'name': 'International Physical Activity Questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. Walking = 3.3 METs Moderate Intensity = 4.0 METs Vigorous Intensity = 8.0 METs Total MET-minutes/week = Walk (METs\\*min\\*days) + Mod (METs\\*min\\*days) + Vig (METs\\*min\\*days)\n\n1\\. Low: • No activity is reported OR • Some activity is reported but not enough to meet Categories 2 or 3. 2. Moderate: • 3 or more days of vigorous activity of at least 20 minutes per day OR • 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR • 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-minutes/week. 3. High: • Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week', 'armGroupLabels': ['Study Group']}, {'name': 'Pittsburgh Sleep Quality Index', 'type': 'DIAGNOSTIC_TEST', 'description': 'The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month.The client self rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5"or greater indicates a "poor" sleeper.', 'armGroupLabels': ['Study Group']}, {'name': 'Physical Activity Awareness Questionnaire - prepared by the researchers', 'type': 'OTHER', 'description': 'It consists of 13 questions to assess the physical activity level awareness of students. The questionnaire was prepared by the researchers therefore it does not have a validation.', 'armGroupLabels': ['Study Group']}, {'name': 'Perceived Stress Scale', 'type': 'DIAGNOSTIC_TEST', 'description': 'The Perceived Stress Scale (PSS) is a classic stress assessment instrument that helps understand how different situations affect feelings and perceived stress. The questions in this scale ask about feelings and thoughts during the last month. It consists of 14 questions.', 'armGroupLabels': ['Study Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Kültür University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Gamze Ertürk', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}