Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 11:40 PM
Study NCT ID:
NCT04775433
Status:
UNKNOWN
Last Update Posted:
2021-05-05
First Post:
2021-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
'The Actual and Perceived Levels of Physical Fitness and Lifestyle Habits in University of Malta Students'
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 384}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-29', 'studyFirstSubmitDate': '2021-02-08', 'studyFirstSubmitQcDate': '2021-02-26', 'lastUpdatePostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol Consumption', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Alcohol Use Disorders Identification Test (AUDIT)'}, {'measure': 'Tobacco Smoking', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Fagerstrom Test for Nicotine Dependence'}, {'measure': 'Sleeping Pattern and Quality', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Pittsburgh Sleep Quality Index'}, {'measure': 'Perceived Physical Fitness', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Self-perceived fitness Questionnaire'}, {'measure': 'Physical Fitness- Body Composition', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Waist Circumference'}, {'measure': 'Physical Fitness- Body Composition', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Body Mass Index'}, {'measure': 'Physical Fitness- Flexibility', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Modified Sit and Reach Test'}, {'measure': 'Physical Fitness- Flexibility', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Back Scratch Test'}, {'measure': 'Physical Fitness- Muscular strength and endurance', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Squats until fatigue'}, {'measure': 'Physical Fitness- Muscular strength and endurance', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Push-Ups until fatigue'}, {'measure': 'Physical Fitness- Cardiovascular Endurance', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Resting Heart Rate (RHR)'}, {'measure': 'Physical Fitness- Cardiovascular Endurance', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Blood Pressure (BP)'}, {'measure': 'Physical Fitness- Cardiovascular Endurance', 'timeFrame': 'through study completion, an average of 1 year.', 'description': '3 Minute Step Test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['perceived,', 'physical fitness', 'lifestyle habits', 'alcohol consumption', 'sleep', 'tobacco smoking'], 'conditions': ['Physical Fitness', 'Lifestyle, Healthy']}, 'descriptionModule': {'briefSummary': 'The ultimate goal for every health-care system is to have a healthy population by maintaining good physical fitness levels and lifestyle habits, including regular physical activity, good sleep quality, smoking and alcohol abstinence. The main components of physical fitness include body composition, muscular strength and endurance, flexibility and cardiovascular endurance. National research based on actual and perceived physical fitness levels in University of Malta (UM) students where both physical and non-physical testing are included, is lacking.\n\nAlso, to the knowledge of the researcher, no such research investigated the relationship between the actual and perceived levels of physical fitness with lifestyle habits (smoking, alcohol consumption and sleep).\n\nThis study aims to investigate the correlation between the actual and perceived levels of physical fitness (body composition, cardiovascular endurance, muscular strength and endurance and flexibility) by physical and non-physical testing, the correlation between lifestyle patterns (smoking, alcohol consumption and sleep.', 'detailedDescription': 'The ultimate goal for every health-care system is to have a healthy population by maintaining good physical fitness levels and lifestyle habits, including regular physical activity, good sleep quality, smoking and alcohol abstinence. The main components of physical fitness include body composition, muscular strength and endurance, flexibility and cardiovascular endurance. A national research based on actual and perceived physical fitness levels in University of Malta (UM) students where both physical and non-physical testing are included, is lacking.\n\nAlso, to the knowledge of the researcher, no such research investigated the relationship between the actual and perceived levels of physical fitness with lifestyle habits (smoking, alcohol consumption and sleep).\n\nThis study aims to investigate the correlation between the actual and perceived levels of physical fitness (body composition, cardiovascular endurance, muscular strength and endurance and flexibility) by physical and non-physical testing, the correlation between lifestyle patterns (smoking, alcohol consumption and sleep.\n\nThis proposed research shall adopt a quantitative-based, correlational type of study design. Registrar and student organisations shall act as intermediary entities and send an information letter via electronic mail to all students aged between 18-30 years. All participants who respond to the call, on attendance to a pre-set date for a face-to-face information session by the researcher, will be asked to sign an informed consent form. Each participant will come for data collection only once at the Department of Physiotherapy laboratories, Faculty of Health Sciences, at the University of Malta and shall take around 20 minutes.\n\nEvery query will be answered, a detailed explanation and demonstration of each test will be given to each participant, and qualified physiotherapists will perform the testing.\n\nIn this proposed study, the aim of The Fagerstrom Test for Nicotine Dependence (FTND), Alcohol Use Disorders Identification Test (AUDIT) and Pittsburgh Sleep Quality Index (PSQI) is to quantitatively study various lifestyle habits in UM students including smoking, alcohol consumption and sleep quality respectively. The Self-Perceived Fitness questionnaire (SPF) shall be used to measure self-perceived physical fitness in University of Malta students. The Fagerstrom Test for Nicotine Dependence is open-access, and can be used for free for research purposes. On the other hand, permissions to use the Alcohol Use Disorders Identification Test, Pittsburgh Sleep Quality Index and Self-Perceived Fitness questionnaire were given by their respective authors.\n\nBody composition shall be measured by Body Mass Index and Waist Circumference, lower and upper limb flexibility shall be measured by Modified Sit and Reach Test and Back Scratch Test respectively. In addition, cardiovascular endurance shall be measured by Resting Heart Rate, Blood Pressure and 3 Min Step Test, while Squats and Push-ups until fatigue shall be used to measure lower and upper limb muscular strength and endurance. All data will then be analysed using statistical methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All university of Malta students, both males and females, and aged between 18-30 years, shall be invited to participate.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all students aged between 18-30 years, and enrolled within the University of Malta in 2021-2022\n\nExclusion Criteria:\n\n* Participants who underwent any orthopaedic surgery/trauma in the previous two years or who suffer from hereditary diseases that may lead to movement restrictions, compromised muscular strength, endurance or flexibility, since any of these may limit generalisability of results.\n* Participants who are taking medications that cause tachycardia, suffer from resting angina, uncontrolled respiratory conditions, diabetes and high blood pressure.'}, 'identificationModule': {'nctId': 'NCT04775433', 'briefTitle': "'The Actual and Perceived Levels of Physical Fitness and Lifestyle Habits in University of Malta Students'", 'organization': {'class': 'OTHER', 'fullName': 'University of Malta'}, 'officialTitle': "'The Actual and Perceived Levels of Physical Fitness and Lifestyle Habits in University of Malta Students'", 'orgStudyIdInfo': {'id': 'UniMalta'}}, 'contactsLocationsModule': {'locations': [{'city': 'Msida', 'status': 'RECRUITING', 'country': 'Malta', 'contacts': [{'name': 'Anthea Zammit', 'role': 'CONTACT', 'email': 'anthea.zammit@um.edu.mt', 'phone': '23401207'}], 'facility': 'Exercise Lab, Physiotherapy Department, Faculty of Health Sciences, Mater Dei Hospital', 'geoPoint': {'lat': 35.8925, 'lon': 14.48278}}], 'centralContacts': [{'name': 'MaryGrace Grima, B.Sc (Hons)', 'role': 'CONTACT', 'email': 'mary.g.grima.14@um.edu.mt', 'phone': '0035679095149'}, {'name': 'Tonio Agius, PhD', 'role': 'CONTACT', 'email': 'tonio.p.agius@um.edu.mt', 'phone': '0035623401821'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Physiotherapy Clinician', 'investigatorFullName': 'Mary Grace Grima', 'investigatorAffiliation': 'University of Malta'}}}}