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CTRI Number  CTRI/2025/11/098199 [Registered on: 28/11/2025] Trial Registered Prospectively
Last Modified On: 07/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A pilot study on physical activity and sitting time among adults 
Scientific Title of Study   Assessment of Physical Activity and Sitting Time among Adults: A Mixed Methods Pilot Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Divyashree Kotian 
Designation  PhD Scholar 
Affiliation  Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal 
Address  Department of Community Medicine, Kasturba Medical College, Manipal Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9535372117  
Fax    
Email  divyashree.kmcmpl2025@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Chythra R Rao 
Designation  Additional Professor 
Affiliation  Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal 
Address  Department of Community Medicine, Kasturba Medical College, Manipal Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448857793  
Fax    
Email  chythra.raj@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Chythra R Rao 
Designation  Additional Professor 
Affiliation  Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal 
Address  Department of Community Medicine, Kasturba Medical College, Manipal Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448857793  
Fax    
Email  chythra.raj@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Madhav Nagar, Manipal, Karnataka, India-576104 
 
Primary Sponsor  
Name  Divyashree Kotian 
Address  Department of Community Medicine, Kasturba Medical College, Manipal Manipal Academy of Higher Education, Manipal  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chythra R Rao  Kasturba Medical College, Manipal  Third floor, Room no. 5, Department of Community Medicine, MAHE, Manipal-576104
Udupi
KARNATAKA 		 08202922324

chythra.raj@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Type 2 diabetes mellitus and Hypertension  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion criteria for the Quantitative part:
1. Adults (both men and women) above the age of 18 years, who are willing to participate in the study

Inclusion criteria for the Qualitative part:
1. Adults (both men and women) above the age of 18 years who are willing to share their perception on physical activity and sedentary behaviour  
 
ExclusionCriteria 
Details  Exclusion criteria for both the Quantitative and Qualitative parts:
1. Physically or mentally challenged individuals
2. Pregnant women

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Prevalence of physical inactivity in the community using the Global Physical Activity Questionnaire (GPAQ) and the validated Active Australia Survey questionnaire
2. Perception and attitude of the individuals towards physical activity and sedentary behaviour 		 Single time point (at baseline) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Due to rapid urbanization and lifestyle modifications, the risk of non-communicable diseases is rising sharply, thereby placing a significant burden on the healthcare system.(1) The World Health Organization (WHO) defines physical activity as “any bodily movement produced by skeletal muscles that requires energy expenditure”.(2) Regular physical activity is essential for maintaining both physical and mental health, whereas sedentary behaviour has emerged as an independent risk factor for several health problems, including diabetes, obesity, cardiovascular diseases, and cancer.(3) Despite the well-established benefits of physical activity, studies conducted in India indicate alarmingly high levels of physical inactivity.(4-8) A study conducted in 2019 reported a prevalence of 71.9% physical inactivity among adults (6), while another study conducted between 2018 and 2019 reported a prevalence of approximately 73% (8). Moreover, evidence from studies conducted in Western settings has demonstrated that a less favourable balance between physical activity and sitting time is associated with an increased risk of all-cause mortality.(9-10) These findings emphasize the need to identify the underlying reasons for such high levels of inactivity. To better understand these perceptions, conducting in-depth interviews that capture community perspectives on physical activity and sedentary behaviour is necessary. Although several studies in India have examined physical activity levels, the balance between physical activity and sitting time remains underexplored. Establishing this balance is crucial, as it is central to achieving optimal health benefits. The applicability of the Active Australia Survey has not been thoroughly studied in India. Given the cultural and lifestyle differences between India and Australia, it is important to assess the feasibility of using this tool in the Indian context. Hence, this pilot study serves as a baseline for assessing the feasibility of utilizing the Active Australia Survey Questionnaire in the Indian population. 

References: 

1. Motuma A, Regassa LD, Gobena T, Roba KT, Berhane Y, Worku A. Almost all working adults have at least one risk factor for non-communicable diseases: Survey of working adults in Eastern Ethiopia. PLoS One 2022;17(2 February). 

2. World Health Organization. Physical activity. World Health Organization2024; 

3. Le Roux E, De Jong NP, Blanc S, Simon C, Bessesen DH, Bergouignan A. Physiology of physical inactivity, sedentary behaviours and non-exercise activity: insights from the space bedrest model. Journal of Physiology2022;600(5):1037–51. 

4. Jalaluddin, Nawab T, Khalique N, Ahmad A. Physical Inactivity and its Sociodemographic Determinants among Adults: A Community-Based Study. Indian Journal of Community Medicine 2024;49(6):849–54. 

5. Newtonraj A, Murugan N, Singh Z, Chauhan RC, Velavan A, Mani M. Factors associated with physical inactivity among adult urban population of Puducherry, India: A population based cross-sectional study. Journal of Clinical and Diagnostic Research 2017;11(5):LC15–7. 

6. Mohanty S, Sahoo J, Epari V, Ganesh GS, Panigrahi SK. Prevalence, Patterns, and Predictors of Physical Inactivity in an Urban Population of India. Cureus 2022; 

7. Anjana RM, Pradeepa R, Das AK, Deepa M, Bhansali A, Joshi SR, et al. Physical activity and inactivity patterns in India - results from the ICMR-INDIAB study (Phase-1) [ICMR-INDIAB-5]. International Journal of Behavioral Nutrition and Physical Activity 2014;11(1). 

8. Verma M, Kalra S, Deepa M, Venkatesan U, Sharma N, Pradeepa R, et al. Understanding Epidemiology of Physical Activity and Sedentary Behaviour Among Adults in Haryana: Insights from the ICMR-INDIAB Study [ICMR-INDIAB-19]. Adv Ther 2025;42(7):3265–84. 

9. Botlero R, Sethi P, Gasevic D, Owen N, Barr E, Dunstan DW. A Physical Activity and Sitting Time Balance Index and All-Cause Mortality Risk. Am J Prev Med 2024;67(6):832–40. 

10. Lian Y, Luo P. Association of Physical Activity and Sitting Time Balance Index with all-cause and cause specific mortality among cancer survivors in the USA: a cohort study. Supportive Care in Cancer 2025;33(7). 

 
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