University StudentsNCT05031988
Determinants of Physical Activity and Mental Health During and After Covid-19 Lockdown
An observational study of University Students, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- University Students
- How many people
- 442 participants
- Where
- 1 siteMalaysia
- Study dates
- 18 Oct 2021to 16 Dec 2021
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy undergraduate students who are currently studying in Universiti Tunku Abdul Rahman without a previous history of depression, anxiety and/or stress.
Who may be able to join
- Undergraduate students studying in Universiti Tunku Abdul Rahman, aged 18-25 years and are willing to participate in this study.
Who cannot join
- Students diagnosed with depression/anxiety or high stress before the implementation of movement control order.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determinants of Physical Activity and Mental Health During and After Covid-19 Lockdown Among University Students
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.
Read the detailed description
Covid-19 by itself is a stressful and difficult health condition to face and deal with, as it not only affects people individually but threatens all those around them due to its highly contagious nature. As a public health emergency declared back in January 2020 by the WHO's Director, the primary worry for everyone is getting infected by the disease due to the ever increasing reported and suspected cases. This instils anxiety and fear and leads to all kinds of behaviours such as self-isolation, the worry of disseminating the disease to loved ones, and suspicion towards acquaintance that promotes paranoia and unhealthy thinking behaviours which propagate many psychological issues. Several studies on past pandemic have shown that these effects may extend to cause long term consequences on the relevant populations which is a concerning problem. Hawryluck et al. reported that following quarantine due to the SARS outbreak back in 2003, a substantial proportion of their participants still exhibits symptoms of Post-Traumatic Stress Disorder and depression. Bai et al study on health care workers during the same outbreak also reports quarantine being the most relevant factor for developing acute stress disorder and some of the participants considering resigning or being reluctant to work due to the outbreak. The health care workers were experiencing more exhaustion, restless sleep, and anxiety as well.
Tertiary level students consist of more out of state students, and this implies that most of them are probably living in hostels or near campus. The sudden lockdown that is imposed during June 2021 forced all the citizens to stay as they are, and prohibit socialization making a sudden change yet again to the environment university students are in after they could return to prepare for physical classes. This may induce a feeling of freedom being stripped away from university students, boredom when they are left all alone and uncertainty over their own health condition which all may prompt negative psychological impacts. The lockdown has also forced closure of academic institutions which leads to the teaching delivery to be converted from physical face-to-face to online. This can cause a whole lot of consequences. The primary concern for all the university students is definitely their academic progression. The students are now anxious about their study completion, whether they will be able to graduate on time and if their programme is still recognised. The running of the exams and those that are living with their family where they must share the load on household chores and taking care of their siblings or family members are some important stressors and can negatively affect thier mental health.
Maintaining PA has been well studied at this point for its effect on the physical health of an individual let it be better musculoskeletal health, reduced risk of developing cardiovascular diseases, or better self-esteem and confidence. Chekroud et al studied on the effect physical exercise has on mental health in their 1.2 million USA individuals and they report that generally physical activity has optimal effect on the mental health of their participants. Those who exercised have lower self-reported mental health burden than those who did not, and this association was consistent across all demographic factors be it age, gender, ethnicity, or household income. However, the type, duration, and intensity of exercise seems to have different ranges of response and it should be noted that more exercise is not always better. In their study, the duration of exercise between 30-60mins has the highest benefits in lowering mental health burden and this slowly declines with more duration of exercise and even worsen the mental state when it exceeds 3 hours.
To summarize, it is shown that physical activity is beneficial even for mental health and although the exact volume of physical exercise that's optimal is still up for discussion with further research delving into this area, we believe it is appropriate to say that exercise of any form is definitely better than being sedentary when it comes to the mental state of an individual. It is without a doubt a protective factor that everyone should maintain especially during these times of uncertainty to be in an optimal headspace. Therefore, aim of this study is to examine the determinanats of physical activity and mental health during and after Covid-19 lockdown among university Tunku Abdul Rahman students. Determinants of physcial activity and mental health are factors including gender, race, living condition, living area, restriction level, family income, and pre-lockdown habits that may or may not have effect on the differences in scores of the outcome measures.
Data will be tabulated into the microsoft excel, and analyzed with the help of SPSS (version 26). Mcnemer test will be used to compare the proportion of participans in each category (variables include gender, race, living condition, living area, restriction level, family income, and pre-lockdown habits) pre lockdown and post lockdown. Chi-square test would be utilized to assess if there is a significant difference between the groups (physically active vs inactive, anxiety vs no anxiety, depression vs no depression). Finally, logistic regeression will be implemented to determine the relationship of each variable with respect to outcome measures (physical activity, anxiety, and depression).
- Conditions
- University Students
- Being tested
- No intervention will be used.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention will be used.Other
Determinants of physical activity and mental health among the students during Covid-19 lockdown will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| University Students | To assess the determinants of physical activity and mental health among university students during and after Covid-19 lockdown. Receives: Other: No intervention will be used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At baseline for a single time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start18 Oct 2021
- Primary completion16 Dec 2021
- Study completion16 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for University StudentsStudies 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
- Prospective
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Tunku Abdul Rahman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imtiyaz Ali Mir, Universiti Tunku Abdul Rahman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031988
- Sponsor's protocol ID
- U/SERC/137/2021
- Status last verified
- Feb 2022
- First submitted
- 1 Sep 2021
- Last updated
- 23 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Physical Activity and Mental Health During and After Covid-19 Lockdown Among University Students
- ClinicalTrials.gov ID
- NCT05031988
- Acronym / sponsor ID
- U/SERC/137/2021
- Conditions
- University Students
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Universiti Tunku Abdul RahmanUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 2 Sep 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.
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.
Detailed description
Covid-19 by itself is a stressful and difficult health condition to face and deal with, as it not only affects people individually but threatens all those around them due to its highly contagious nature. As a public health emergency declared back in January 2020 by the WHO's Director, the primary worry for everyone is getting infected by the disease due to the ever increasing reported and suspected cases. This instils anxiety and fear and leads to all kinds of behaviours such as self-isolation, the worry of disseminating the disease to loved ones, and suspicion towards acquaintance that promotes paranoia and unhealthy thinking behaviours which propagate many psychological issues. Several studies on past pandemic have shown that these effects may extend to cause long term consequences on the relevant populations which is a concerning problem. Hawryluck et al. reported that following quarantine due to the SARS outbreak back in 2003, a substantial proportion of their participants still exhibits symptoms of Post-Traumatic Stress Disorder and depression. Bai et al study on health care workers during the same outbreak also reports quarantine being the most relevant factor for developing acute stress disorder and some of the participants considering resigning or being reluctant to work due to the outbreak. The health care workers were experiencing more exhaustion, restless sleep, and anxiety as well.
Tertiary level students consist of more out of state students, and this implies that most of them are probably living in hostels or near campus. The sudden lockdown that is imposed during June 2021 forced all the citizens to stay as they are, and prohibit socialization making a sudden change yet again to the environment university students are in after they could return to prepare for physical classes. This may induce a feeling of freedom being stripped away from university students, boredom when they are left all alone and uncertainty over their own health condition which all may prompt negative psychological impacts. The lockdown has also forced closure of academic institutions which leads to the teaching delivery to be converted from physical face-to-face to online. This can cause a whole lot of consequences. The primary concern for all the university students is definitely their academic progression. The students are now anxious about their study completion, whether they will be able to graduate on time and if their programme is still recognised. The running of the exams and those that are living with their family where they must share the load on household chores and taking care of their siblings or family members are some important stressors and can negatively affect thier mental health.
Maintaining PA has been well studied at this point for its effect on the physical health of an individual let it be better musculoskeletal health, reduced risk of developing cardiovascular diseases, or better self-esteem and confidence. Chekroud et al studied on the effect physical exercise has on mental health in their 1.2 million USA individuals and they report that generally physical activity has optimal effect on the mental health of their participants. Those who exercised have lower self-reported mental health burden than those who did not, and this association was consistent across all demographic factors be it age, gender, ethnicity, or household income. However, the type, duration, and intensity of exercise seems to have different ranges of response and it should be noted that more exercise is not always better. In their study, the duration of exercise between 30-60mins has the highest benefits in lowering mental health burden and this slowly declines with more duration of exercise and even worsen the mental state when it exceeds 3 hours.
To summarize, it is shown that physical activity is beneficial even for mental health and although the exact volume of physical exercise that's optimal is still up for discussion with further research delving into this area, we believe it is appropriate to say that exercise of any form is definitely better than being sedentary when it comes to the mental state of an individual. It is without a doubt a protective factor that everyone should maintain especially during these times of uncertainty to be in an optimal headspace. Therefore, aim of this study is to examine the determinanats of physical activity and mental health during and after Covid-19 lockdown among university Tunku Abdul Rahman students. Determinants of physcial activity and mental health are factors including gender, race, living condition, living area, restriction level, family income, and pre-lockdown habits that may or may not have effect on the differences in scores of the outcome measures.
Data will be tabulated into the microsoft excel, and analyzed with the help of SPSS (version 26). Mcnemer test will be used to compare the proportion of participans in each category (variables include gender, race, living condition, living area, restriction level, family income, and pre-lockdown habits) pre lockdown and post lockdown. Chi-square test would be utilized to assess if there is a significant difference between the groups (physically active vs inactive, anxiety vs no anxiety, depression vs no depression). Finally, logistic regeression will be implemented to determine the relationship of each variable with respect to outcome measures (physical activity, anxiety, and depression).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| University Students | – | Other: No intervention will be used.To assess the determinants of physical activity and mental health among university students during and after Covid-19 lockdown. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy undergraduate students who are currently studying in Universiti Tunku Abdul Rahman without a previous history of depression, anxiety and/or stress.
Key inclusion criteria (1 listed)
- Undergraduate students studying in Universiti Tunku Abdul Rahman, aged 18-25 years and are willing to participate in this study.
Key exclusion criteria (1 listed)
- Students diagnosed with depression/anxiety or high stress before the implementation of movement control order.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention will be used.Determinants of physical activity and mental health among the students during Covid-19 lockdown will be assessed. | Other | University Students |
Primary outcome
Physical Activity Level
Time frame: At baseline for a single time.
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.
Depression
Time frame: At baseline for a single time.
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.
Anxiety
Time frame: At baseline for a single time.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 University Students, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
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 1 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: finished, as of the sponsor's last update on 23 Feb 2022. 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Level (time frame: At baseline for a single time.). The study lists 3 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 23 Feb 2022.