NCT05031988

Brief Summary

Covid-19 pandemic has affected the entire globe for the past 2 years on a major scale, causing never before seen major effects on the way we live probably for the near future. SARS-Cov-2, previously known as coronavirus, is the causative virus for this disease and it originates from Wuhan, China with its first reported case of human infection back in December 2019. From there, it quickly resulted in an outbreak which was first unsuccessfully contained by the China government and has spread across the globe causing more than 187 million positive cases and 4.05 million deaths at the time of writing this proposal. For this reason, various measures have been implemented to control the spread of the virus with the main one to be discussed for reasons of this research, the movement restriction order (MCO). MCO was implemented to limit and control the local outbreak by restraining the movements of the people only to the absolute necessary. Social and religious gatherings, outdoor recreational activities, operation of learning institution of all levels are among those prohibited, only allowing essential goods store and health care facility centres to operate for the period. Thus, this study is done to assess the impact Covid-19 movement restriction has had on university students from a physical and psychological standpoint during the MCO period. The implementation of the various restriction order has caused the students to go through numerous cycles of distress and it is of importance to determine the impact it has done to be able to provide the appropriate support if needed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
442

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 18, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2021

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

September 1, 2021

Last Update Submit

February 6, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Physical Activity Level

    Short form version of International Physical Activity Questionnaire (IPAQ-SF) will be used to determine the physical activity level of students. The questionnaire features 7 questions that relates to the frequency and duration the participant spends in various forms/intensity of physical activity over a period of one week and will categorize the participants into insufficiently active, minimally active and HEPA groups.

    At baseline for a single time.

  • Depression

    Patient Health Questionaire-8 will be administered to evaluate the depression. Scoring of this questionnaire is based on a 4-point Likert scale, 0 having the least value and 3 maximum value.

    At baseline for a single time.

  • Anxiety

    General Anxiety Disorder-7 scale will be used to examine the level of anxiety. Scoring of this questionnaire is based on a 4-point Likert scale, 0 having the least value and 3 maximum value.

    At baseline for a single time.

Study Arms (1)

University Students

To assess the determinants of physical activity and mental health among university students during and after Covid-19 lockdown.

Other: No intervention will be used.

Interventions

Determinants of physical activity and mental health among the students during Covid-19 lockdown will be assessed.

University Students

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy undergraduate students who are currently studying in Universiti Tunku Abdul Rahman without a previous history of depression, anxiety and/or stress.

You may qualify if:

  • Undergraduate students studying in Universiti Tunku Abdul Rahman, aged 18-25 years and are willing to participate in this study.

You may not qualify if:

  • Students diagnosed with depression/anxiety or high stress before the implementation of movement control order.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Tunku Abdul Rahman

Kajang, Selangor, 43000, Malaysia

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 2, 2021

Study Start

October 18, 2021

Primary Completion

December 16, 2021

Study Completion

December 16, 2021

Last Updated

February 23, 2022

Record last verified: 2022-02

Locations