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Pharmacy & Pharmacology International Journal

Research Article Volume 6 Issue 6

LC-MS/MS method development and validation of an antihistaminic, calcium channel blocker, di-phenyl-methyl-piperazine group containing cinnarizine in human plasma with an application to BA/BE studies in Indian volunteer

Pallab Mandal,1,2 Shubhasis Dan,1,3 Anirbandeep Bose,3 Suparna Bag,3 Arunava Biswas,4 Jasmina Khanam,2 Tapan Kumar Pal1

1Bioequivalence Study Centre, Department of Pharmaceutical Technology, India
2Department of Pharmaceutical Technology, Jadavpur University, India
3TAAB Biostudy Services, India
4Calcutta National Medical College and Hospital, India

Correspondence: Tapan Kumar Pal, Emeritus Medical Scientist (ICMR), Bioequivalence Study Centre, Dept. of Pharmaceutical Technology, Jadavpur University, Kolkata-700 032, India, Tel 91- 33-24146967, Fax 91-33-24146186

Received: November 15, 2018 | Published: December 7, 2018

Citation: Mandal P, Dan S, Bose A, et al. LC-MS/MS method development and validation of an antihistaminic, calcium channel blocker, di-phenyl-methylpiperazine group containing cinnarizine in human plasma with an application to BA/BE studies in Indian volunteer. Pharm Pharmacol Int J. 2018;6(6):475-482. DOI: 10.15406/ppij.2018.06.00221

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Abstract

Introduction: The current study was undertaken with the aim to assess the barriers to physical activities among university undergraduates enrolled in a public sector university in Malaysia.

Methods: A questionnaire based, cross sectional study was carried out at Universiti Sains Malaysia main campus in Penang, Malaysia. Four hundred and eighty undergraduates participated in the study. The p<0.05 was taken as significant.

Results: The mean age of the respondents was 22.5±3.1 with 66% (n=317). One hundred and eighty four (38.3%) of the students agreed that they cannot include physical activity in their regular schedule because of their busy schedule and on the other hand 199 (41.5%) of the respondents reported tiredness and exhaustion as a key reason for physical inactivity. Additionally, lack of motivation found as a barrier to physical activity (n=259, 54.0%). Physical activity and commitments to study and research were significantly associated with sample clusters (p=0.024). Furthermore, physical activity and commitments to study and research were also associated with sex (p<0.001).

Conclusion: The university policymakers have to draft supportive strategies to help students to overcome the reported barriers to physical activities.

Keywords: cross-sectional study, barriers, physical activities, university students–Malaysia

Introduction

The prevalence of non-communicable diseases (NCDs) is on the rise and has become a continuous threat to human beings and the healthcare systems around the globe.1 Several factors are associated with NCDs prevalence where the relationship between obesity and NCDs is well established.2 In Malaysia the obesity rates are alarmingly high and the country is ranked highest in obesity among the Asian countries.3 Insufficient physical activity is a known cause for developing obesity and hence resulting in NCDs.4,5 Systematic physical exercise is recommended to invalidate the pervasiveness of NCDs among a population of all age groups.6 Decline in physical activity leads to significant weight gain and obesity that was prevalent in high school and university-aged students.7,8 The identification of the reasons and barriers behind the lack of physical inactivity among university students can be used as foundation in developing and implementing successful physical activity promotion programs.9

In context to physical activity and the Malaysian population, the World Health Organisation reported that 61.4% of the Malaysians aging 15 years and above were physically inactive, hence placing Malaysia the top ten most physically inactive countries in Asian.4 Among developing populations, barriers towards physical activity are attributed to advances in technology, urbanization of the population and the mechanization within the workplace.10,11 Additionally, the physical activity and sports practice are associated with leisure time that is least seen because of busy routine and long working hours.10 Despite of the mentioned barriers, positive health behaviour can leads towards regular exercise and physical activity, as individual’s perceived that physical activity can and regular workout can assist in preventing from diseases and improve health and well being. As defined by Kasl and Cobb health behaviours as “any activity undertaken for the purpose of preventing or detecting disease or for improving health and well being”.12 Behaviour change can play a pivotal role in supporting individuals, though; this perception is complex and can be explained through the Transtheoretical Model of Health Behaviour (TTM). The TTM highlights six stages of change; and one of the stages are that “most of the individuals are often unaware of their current behaviour or they are discouraged about their abilities to change,” while this stage is frequently misinterpreted that people are willing or have a desire to change, which are associated negative consequences13 such as stress.4 In addition, reviewing other relevant theories can assist the policymakers in designing behaviour change models. For example, Lewin’s seminal field behaviour theory (1935) counted as one of the early theories and serves an intellectual asset in health behaviour change interventions.14

There are many other theories which discuss the facilitators and barriers (actors and factors) to behaviour change. To further supplement the research Rosenstock, Hochbaum worked on Health belief model (HBM) to understand the relationship of health behaviours, practices and utilization of health services.15 In the last two decades, significant development seen in understanding determinants of individuals’ health-related behaviours and ways to encourage positive behaviour changes.16 In addition, the Value expectancy theories, which incorporate the HBM and the Theory of Reasoned Action (TRA) and its associate, the Theory of Planned Behavior (TPB), developed throughout this period.14,17,18 However, little information of barriers towards physical activity among university students is available from Malaysia. Therefore, in the present study, we explored barriers towards physical activity among university students to get an insight that can assist the policy makers and authorities in formulating procedures based on discussed health belief models for positive social behaviour change and health promotion activities at the university level.

Material and methods

Study design and settings

This was a questionnaire based, cross sectional study, conducted at Universiti Sains Malaysia (USM) main campus, located in the state of Penang, Malaysia.19 Undergraduates aged 18 years and above, Malaysian citizens, full time student and fluent in English language were included in the study.

Sampling

A non-probability sampling technique (convenience method) was used to approach the students of either gender in the university’s main campus.

Study instrument

A 19-itemed questionnaire was developed after an extensive literature review.13, 20, 21 The first section was based on four demographic questions. The second part comprised of 15 questions based on a 3 point Likert scale focusing barriers towards physical activity. Two experts at School of Pharmaceutical Sciences, USM, conducted the validity of the questionnaire. A Little modification was needed and the instrument was piloted with 25 undergraduates enrolled at USM.

Statistical analysis

The Kolmogorov–Smirnov (KS) test was used for normality assessment and nonparametric tests were used accordingly. SPSS v. 22 was used for data analysis. For descriptive, the data was processed and analyzed using frequencies and percentage. Chi-square, Mann-Whitney U and Kruskal-Wallis test was used to evaluate the associations among demographics and barriers towards physical activities. A p-value less than 0.05 was taken significant and interpretation of the statistical methods was conducted accordingly.

Results

The mean age of the respondents was 22.5±3.1 with 66% (n=317) of females. Majority of respondents belonged to the Malay ethnic group (n=229, 47.7%) followed by Chinese (n=170, 35.4%), Table 1. Results from Table 2 revealed that 184 (38.3%) of the students agreed that they cannot include physical activity in their regular schedule because of their busy days at the university. Being involved in a number of activities at the respective schools, 199 (41.5%) of the respondents reported tiredness and exhaustion as a key reason for physical inactivity. Additionally, lack of motivation, how and when to start the physical activity, was also mentioned as a barrier to physical activity (n=259, 54.0%). The relationship analysis among demographics and study variable is presented in Table 3. Physical activity and commitments to study and research were significantly associated (p=0.024) and Bonferroni adjustment revealed a significant association among pure sciences and applied sciences (p<0.001). Non-involvement of friends and social activities with friends was reported to have a significant relationship with sex (p=0.008 and p=0.007) respectively. Furthermore, physical activity and commitments to study and research were also associated with sex (p<0.001) whereby females were in agreement as compared to males. Other than that, no significant association was reported among sex and other study variables.

Characteristics

Frequency (N)

Percentage (%)

Age (22.5±3.1)

Sex

Male

163

34

Female

317

66

Ethnic group

Malay

229

47.7

Chinese

170

35.4

Indian

56

11.7

Others

25

5.2

Sample cluster

Applied sciences

120

25

Pure sciences

120

25

Applied arts

120

25

Pure arts

120

25

Table 1 Demographic characteristics

Question

Agree (n, %)

Neutral (n, %)

Disagree (n, %)

My day is so busy now, I just don’t think I can make the time to include physical activity in my regular schedule

184 (38.3)

181 (37.7)

115 (24.0)

None of my friends likes to do anything active, so I don’t have a chance to exercise

95 (19.8)

144 (30.0)

241 (50.2)

I’m just too tired after school to get any exercise

199 (41.5)

187 (39.0)

93 (19.4)

I’ve been thinking about getting more exercise, but I just can’t seem to get started

259 (54.0)

125 (26.0)

96 (20.0)

I don’t get enough exercise because I have never learned the skills for any sports

96 (20.0)

142 (29.6)

242 (50.4)

I don’t have access to jogging trails, swimming pools, bike paths etc.

75 (15.6)

139 (29.0)

266 (55.4)

Physical activity takes too much time away from other commitments-time, study, research, co-curriculum etc.

118 (24.6)

182 (37.9)

180 (37.5)

I do not get enough sleep as it is. I just couldn’t get up early or stay up late to get some exercise

182 (37.9)

170 (35.4)

128 (26.7)

It’s easier for me to find excuses not to exercise than to go out to do something

157 (32.7)

185 (38.5)

138 (28.8)

It is just too expensive. You have to take class or join a club or buy the right equipment

85 (17.7)

130 (27.1)

265 (55.2)

My free times during the day are too short to include exercise

200 (41.7)

173 (36.0)

107 (22.3)

My usual social activities with friends do not include physical activities

152 (31.7)

184 (38.3)

144 (30.0)

I’m too tired during the week and I need the weekend to catch up on my rest

230 (47.9)

144 (30.0)

106 (22.1)

I want to get more exercises, but I just can’t seem to make myself stick to anything

209 (43.5)

182 (37.9)

88 (18.3)

If I had exercise facilities at my school, then I would be more likely to exercise

180 (37.5)

204 (42.5)

96 (20.0)

Table 2 Response to study questionnaire

Question

P-Value

Age*

Sex**

Ethnicity

Cluster

My day is so busy now, I just don’t think I can make the time to include physical activity in my regular schedule

0.211

0.144

0.244

0.255

None of my friends likes to do anything active, so I don’t have a chance to exercise

0.256

0.008

0.656

0.211

I’m just too tired after school to get any exercise

0.141

0.251

0.225

0.317

I’ve been thinking about getting more exercise, but I just can’t seem to get started

0.323

0.269

0.445

0.095

I don’t get enough exercise because I have never learned the skills for any sports

0.656

0.887

0.878

0.087

I don’t have access to jogging trails, swimming pools, bike paths etc.

0.2

0.655

0.334

0.112

Physical activity takes too much time away from other commitments-time, study, research, co-curriculum etc.

0.747

<0.001

0.363

0.024

I do not get enough sleep as it is. I just couldn’t get up early or stay up late to get some exercise

0.265

0.898

0.981

0.277

It’s easier for me to find excuses not to exercise than to go out to do something

0.245

0.442

0.332

0.151

It is just too expensive. You have to take class or join a club or buy the right equipment

0.698

0.655

0.441

0.237

My free times during the day are too short to include exercise

0.357

0.32

0.661

0.554

My usual social activities with friends do not include physical activities

0.299

0.007

0.778

0.985

I’m too tired during the week and I need the weekend to catch up on my rest

0.147

0.851

0.441

0.664

I want to get more exercises, but I just can’t seem to make myself stick to anything

0.585

0.363

0.558

0.244

If I had exercise facilities at my school, then I would be more likely to exercise

0.965

0.541

0.771

0.144

Table 3 Association between questions and demographic variables

*Chi Square test, **Man Whitney test, Kruskal Wallis test (adjustment at p≤0.0125)

Discussion

Clinical reports and increasing research evidences revealed that physical activity and supervised exercise has the potential of increasing or maintaining the well-being, sustained health-related quality of life and longevity.20,21 On the other hand, physical inactivity, sedentary life combined with study related stress can lead to health imbalance. Therefore, physical activity is broadly recognized as a significant behavioural feature for health promotion and disease control22 and health enhancement.23 Given this, it is important to identify the barriers towards physical which in turn assist in designing health promotion models and interventions. USM offers key opportunities and facilities to promote physical activity among students; however, there is lack of information about barriers to physical education among our study population. The present study highlighted busy schedule and lack of time as a major barrier towards physical activity and similar outcomes were reported in studies carried out among university students.24,25 The respondents were also agreed that they are too exhausted and fatigued for physical activities after school hours. Our findings are in line with what was reported by studies conducted in 2006 and 2010 of the same nature.10,26 Awareness campaigns and recommending self- efficacy into health education programs can lead to positive health behaviour changes.27

As a perceived barrier, most of the students do not perform exercise due to lack of free time during the day, “or "they feel too tired during the week and they need to rest during the weekend." The insufficiency of time as a barrier to physical activity suggests that students are missing effective time management skills.25 This is further augmented by the statement whereby the students agreed that "they have been thinking about getting more exercise but just cannot seem to get started". From our experiences, it seems that students at USM are interested in physical activities but lack the required motivation. Research shows that motivation is an important factor in supporting continued exercise and physical activity, which is closely linked to health outcomes. Therefore, according to another research self-determination theory (SDT) has influence on exercise motivation,28 by focusing on extrinsic and intrinsic motivation factors. It is of paramount importance that students are required to be motivated internally as externally-driven motivation may not lead to sustainable physical activity.28 During the analysis, it was perceived that large numbers of students are either unmotivated or not sufficiently motivated to be physically active, or are motivated temporarily. To overcome motivation and time-related issues, it is recommended to introduce web-based health behaviour change programs through USM website or by developing dedicated mobile application.29

Looking into the role of website and internet in behaviour change, a research reviews conducted on 37 public websites on health behaviour change for disease prevention and management, shows that all had four of five of the `5A's for effective health behaviour change treatment on the Internet' (advise, assess, assist, anticipatory guidance and arrange follow-up). These are believed to be minimum criteria for a program to have the potential for producing behaviour change.30,31 A significant association was reported between sex and non-involvement of friends, social activities and commitments to study and research whereby females were in agreement to the statements as compared to males. In general, females carry more perceived barriers and thus have probabilities of becoming physically inactive.32,33 This is true in our case where female students seem to have more perceived barriers as compared to males. Cheah and Bee reported that females are less likely to be physically active than others.34 Scheerder et al.,35 also found that women had a lower likelihood of participating in physical activity. However, the reasons for sex differences in perceived barriers towards physical activity are not entirely clear and factors that give rise to higher levels of perceived barriers among females need to be examined speculatively. A possible explanation of this non-involvement is linked to the traditional role of sex because females carry a small social circle and are more studious by nature, therefore, are less involved in physical activities. On the other hand, it is a common observation that females, in general, are not interested in vigorous physical activity as compared to males.

Physical activity and commitment to study and research were significantly associated with sample clusters (p=0.024). It is of common observation that students of the science cluster are heavily involved in university as compared to arts students. The science students have to follow rigorous laboratory sessions and field trips that require additional working hours. A research conducted at Durham University reported that students of science actually find it harder to achieve top grades in subjects like Physics, Chemistry and Biology as they were a little harder than Drama, Sociology or Media Studies.3 It was also speculated that students will be more likely to choose to study ‘easier’ subjects and will not opt to study science subjects that are desperately needed by employers in the knowledge economy.3 As science subjects are tough and need intensive involvement, this can be one possible explanation of science students being agreed with less involvement in physical activity. The present study highlighted several barriers towards physical activity among university students. University policymakers have to draft supportive strategies and sport management guidelines that will help in sustaining a healthier environment. In addition, the study findings can help in beginning an explicit discussion among policymakers, stakeholders and university management to promote physical activities among university students in order to raise awareness towards the positivity of physical education among students.

Limitations

Despite that study results are promising and can help the policymakers in developing physical education programs and curriculum for university, it had limitations:

    1. The study only focused on USM, therefore the results cannot be generalized to entire universities in Malaysia, therefore further research is recommended;
    2. Study do not cover the recommendations from university students towards designing effective physical education programs;
    3. It was not within the scope of this study to provide clinical consequence of physical inactivity or the diseased caused by.

Data availability

All the data is available within the manuscript. However, we will share our datasets and spreadsheets per individual request.

Conflicts of interest

Authors declare that they have no conflicts of interest.

Funding statement

No funding was received for this study.

Acknowledgments

None.

Ethics approval and consent to participate

Departmental Ethical Committee of Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, USM approved the study. In addition, written consent was also obtained from the study respondents. Participation in this study was voluntary and the anonymity of the sample was preserved and assured.

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