Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05031988 |
| Other study ID # |
U/SERC/137/2021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 18, 2021 |
| Est. completion date |
December 16, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Universiti Tunku Abdul Rahman |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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).
