NCT04775433

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
384

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

1.5 years

First QC Date

February 8, 2021

Last Update Submit

April 29, 2021

Conditions

Keywords

perceived,physical fitnesslifestyle habitsalcohol consumptionsleeptobacco smoking

Outcome Measures

Primary Outcomes (13)

  • Alcohol Consumption

    Alcohol Use Disorders Identification Test (AUDIT)

    through study completion, an average of 1 year.

  • Tobacco Smoking

    Fagerstrom Test for Nicotine Dependence

    through study completion, an average of 1 year.

  • Sleeping Pattern and Quality

    Pittsburgh Sleep Quality Index

    through study completion, an average of 1 year.

  • Perceived Physical Fitness

    Self-perceived fitness Questionnaire

    through study completion, an average of 1 year.

  • Physical Fitness- Body Composition

    Waist Circumference

    through study completion, an average of 1 year.

  • Physical Fitness- Body Composition

    Body Mass Index

    through study completion, an average of 1 year.

  • Physical Fitness- Flexibility

    Modified Sit and Reach Test

    through study completion, an average of 1 year.

  • Physical Fitness- Flexibility

    Back Scratch Test

    through study completion, an average of 1 year.

  • Physical Fitness- Muscular strength and endurance

    Squats until fatigue

    through study completion, an average of 1 year.

  • Physical Fitness- Muscular strength and endurance

    Push-Ups until fatigue

    through study completion, an average of 1 year.

  • Physical Fitness- Cardiovascular Endurance

    Resting Heart Rate (RHR)

    through study completion, an average of 1 year.

  • Physical Fitness- Cardiovascular Endurance

    Blood Pressure (BP)

    through study completion, an average of 1 year.

  • Physical Fitness- Cardiovascular Endurance

    3 Minute Step Test

    through study completion, an average of 1 year.

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All university of Malta students, both males and females, and aged between 18-30 years, shall be invited to participate.

You may qualify if:

  • all students aged between 18-30 years, and enrolled within the University of Malta in 2021-2022

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Lab, Physiotherapy Department, Faculty of Health Sciences, Mater Dei Hospital

Msida, Malta

RECRUITING

MeSH Terms

Conditions

Alcohol DrinkingTobacco Smoking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorSmokingTobacco Use

Central Study Contacts

MaryGrace Grima, B.Sc (Hons)

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Physiotherapy Clinician

Study Record Dates

First Submitted

February 8, 2021

First Posted

March 1, 2021

Study Start

March 15, 2021

Primary Completion

September 30, 2022

Study Completion

May 30, 2023

Last Updated

May 5, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations