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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04775433
Other study ID # UniMalta
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2021
Est. completion date May 30, 2023

Study information

Verified date April 2021
Source University of Malta
Contact MaryGrace Grima, B.Sc (Hons)
Phone 0035679095149
Email mary.g.grima.14@um.edu.mt
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 384
Est. completion date May 30, 2023
Est. primary completion date September 30, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - all students aged between 18-30 years, and enrolled within the University of Malta in 2021-2022 Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Malta Exercise Lab, Physiotherapy Department, Faculty of Health Sciences, Mater Dei Hospital Imsida

Sponsors (1)

Lead Sponsor Collaborator
University of Malta

Country where clinical trial is conducted

Malta, 

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol Consumption Alcohol Use Disorders Identification Test (AUDIT) through study completion, an average of 1 year.
Primary Tobacco Smoking Fagerstrom Test for Nicotine Dependence through study completion, an average of 1 year.
Primary Sleeping Pattern and Quality Pittsburgh Sleep Quality Index through study completion, an average of 1 year.
Primary Perceived Physical Fitness Self-perceived fitness Questionnaire through study completion, an average of 1 year.
Primary Physical Fitness- Body Composition Waist Circumference through study completion, an average of 1 year.
Primary Physical Fitness- Body Composition Body Mass Index through study completion, an average of 1 year.
Primary Physical Fitness- Flexibility Modified Sit and Reach Test through study completion, an average of 1 year.
Primary Physical Fitness- Flexibility Back Scratch Test through study completion, an average of 1 year.
Primary Physical Fitness- Muscular strength and endurance Squats until fatigue through study completion, an average of 1 year.
Primary Physical Fitness- Muscular strength and endurance Push-Ups until fatigue through study completion, an average of 1 year.
Primary Physical Fitness- Cardiovascular Endurance Resting Heart Rate (RHR) through study completion, an average of 1 year.
Primary Physical Fitness- Cardiovascular Endurance Blood Pressure (BP) through study completion, an average of 1 year.
Primary Physical Fitness- Cardiovascular Endurance 3 Minute Step Test through study completion, an average of 1 year.
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