Physical FitnessNCT04775433
'The Actual and Perceived Levels of Physical Fitness and Lifestyle Habits in University of Malta Students'
An observational study of Physical Fitness and Lifestyle, Healthy, run by University of Malta at 1 site in Malta.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Physical Fitness, Lifestyle, Healthy
- How many people
- 384 participants
- Where
- 1 siteMalta
- Study dates
- 15 Mar 2021to 30 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Adult
Study population: All university of Malta students, both males and females, and aged between 18-30 years, shall be invited to participate.
Who may be able to join
- all students aged between 18-30 years, and enrolled within the University of Malta in 2021-2022
Who cannot join
- 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.
- Participants who are taking medications that cause tachycardia, suffer from resting angina, uncontrolled respiratory conditions, diabetes and high blood pressure.
Trial locations and contacts
1 site in 1 country.
Malta1 site, 1 recruiting
- Recruiting
Exercise Lab, Physiotherapy Department, Faculty of Health Sciences, Mater Dei Hospital
Msida
Anthea Zammit, 23401207, anthea.zammit@um.edu.mt
About this study
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.
Also, 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).
This 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.
Read the detailed description
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.
Also, 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).
This 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.
This 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.
Every 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.
In 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.
Body 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.
- Conditions
- Physical Fitness, Lifestyle, Healthy
- Keywords
- perceived,, physical fitness, lifestyle habits, alcohol consumption, sleep, tobacco smoking
- Medical subject headings
- Alcohol Drinking, Tobacco Smoking
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Consumption
Alcohol Use Disorders Identification Test (AUDIT)
Measured: through study completion, an average of 1 year.
Tobacco Smoking
Fagerstrom Test for Nicotine Dependence
Measured: through study completion, an average of 1 year.
Sleeping Pattern and Quality
Pittsburgh Sleep Quality Index
Measured: through study completion, an average of 1 year.
Perceived Physical Fitness
Self-perceived fitness Questionnaire
Measured: through study completion, an average of 1 year.
Physical Fitness- Body Composition
Waist Circumference
Measured: through study completion, an average of 1 year.
Physical Fitness- Body Composition
Body Mass Index
Measured: through study completion, an average of 1 year.
Physical Fitness- Flexibility
Modified Sit and Reach Test
Measured: through study completion, an average of 1 year.
Physical Fitness- Flexibility
Back Scratch Test
Measured: through study completion, an average of 1 year.
Physical Fitness- Muscular strength and endurance
Squats until fatigue
Measured: through study completion, an average of 1 year.
Physical Fitness- Muscular strength and endurance
Push-Ups until fatigue
Measured: through study completion, an average of 1 year.
Physical Fitness- Cardiovascular Endurance
Resting Heart Rate (RHR)
Measured: through study completion, an average of 1 year.
Physical Fitness- Cardiovascular Endurance
Blood Pressure (BP)
Measured: through study completion, an average of 1 year.
Physical Fitness- Cardiovascular Endurance
3 Minute Step Test
Measured: through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start15 Mar 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical FitnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Grace Grima, University of Malta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775433
- Sponsor's protocol ID
- UniMalta
- Status last verified
- Apr 2021
- First submitted
- 8 Feb 2021
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'The Actual and Perceived Levels of Physical Fitness and Lifestyle Habits in University of Malta Students'
- ClinicalTrials.gov ID
- NCT04775433
- Acronym / sponsor ID
- UniMalta
- Conditions
- Physical Fitness, Lifestyle, Healthy
- Keywords
- perceived,, physical fitness, lifestyle habits, alcohol consumption, sleep, tobacco smoking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- University of MaltaUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Also, 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).
This 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.
Detailed description
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.
Also, 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).
This 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.
This 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.
Every 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.
In 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.
Body 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Age groups
- Adult
- Study population
- All university of Malta students, both males and females, and aged between 18-30 years, shall be invited to participate.
Key inclusion criteria (1 listed)
- all students aged between 18-30 years, and enrolled within the University of Malta in 2021-2022
Key exclusion criteria (2 listed)
- 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.
- Participants who are taking medications that cause tachycardia, suffer from resting angina, uncontrolled respiratory conditions, diabetes and high blood pressure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alcohol Consumption
Time frame: through study completion, an average of 1 year.
Alcohol Use Disorders Identification Test (AUDIT)
Tobacco Smoking
Time frame: through study completion, an average of 1 year.
Fagerstrom Test for Nicotine Dependence
Sleeping Pattern and Quality
Time frame: through study completion, an average of 1 year.
Pittsburgh Sleep Quality Index
Perceived Physical Fitness
Time frame: through study completion, an average of 1 year.
Self-perceived fitness Questionnaire
Physical Fitness- Body Composition
Time frame: through study completion, an average of 1 year.
Waist Circumference
Physical Fitness- Body Composition
Time frame: through study completion, an average of 1 year.
Body Mass Index
Physical Fitness- Flexibility
Time frame: through study completion, an average of 1 year.
Modified Sit and Reach Test
Physical Fitness- Flexibility
Time frame: through study completion, an average of 1 year.
Back Scratch Test
Physical Fitness- Muscular strength and endurance
Time frame: through study completion, an average of 1 year.
Squats until fatigue
Physical Fitness- Muscular strength and endurance
Time frame: through study completion, an average of 1 year.
Push-Ups until fatigue
Physical Fitness- Cardiovascular Endurance
Time frame: through study completion, an average of 1 year.
Resting Heart Rate (RHR)
Physical Fitness- Cardiovascular Endurance
Time frame: through study completion, an average of 1 year.
Blood Pressure (BP)
Physical Fitness- Cardiovascular Endurance
Time frame: through study completion, an average of 1 year.
3 Minute Step Test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Fitness and Lifestyle, Healthy, run by University of Malta at 1 site in Malta.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malta. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MaryGrace Grima, B.Sc (Hons) (0035679095149, mary.g.grima.14@um.edu.mt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Consumption (time frame: through study completion, an average of 1 year.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.