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CTRI Number  CTRI/2024/12/077923 [Registered on: 10/12/2024] Trial Registered Prospectively
Last Modified On: 12/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study on how physical activity, stress and sleep affect the Quality of Life in Adults 
Scientific Title of Study   Assessing the impact of Physical Activity, Stress and Sleep Quality on Health Related Quality of Life among Adults 
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manisha Riya Gauncar 
Designation  Student 
Affiliation  Prasanna School of Public Health 
Address  Department of Healthcare and Hospital Management, Prasanna School of Public Health, MAHE, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9067483540  
Fax    
Email  manisha1.psphmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swathi K S 
Designation  Associate Professor 
Affiliation  Prasanna School of Public Health 
Address  Department of Healthcare and Hospital Management, Prasanna School of Public Health, MAHE, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9481749911  
Fax    
Email  swathi.ks@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Manisha Riya Gauncar 
Designation  Student 
Affiliation  Prasanna School of Public Health 
Address  Department of Healthcare and Hospital Management, Prasanna School of Public Health, MAHE, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9067483540  
Fax    
Email  manisha1.psphmpl2023@learner.manipal.edu  
 
Source of Monetary or Material Support  
Department of Healthcare and Hospital Management, Prasanna School of Public Health, MAHE, Manipal, Karnataka 576104 
 
Primary Sponsor  
Name  Manisha Riya Gauncar 
Address  Department of Healthcare and Hospital Management, Prasanna School of Public Health, MAHE, Manipal, Karnataka 576104 
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 Swathi K S  Prasanna School of Public Health  Room No. 68, Department of Healthcare and Hospital Management, MAHE, Manipal, Karnataka, 576104
Udupi
KARNATAKA 
9481749911

swathi.ks@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 - Student Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Health Related Quality of Life 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  64.00 Year(s)
Gender  Both 
Details  Adults who are willing to participate in the study and have provided informed consent
Individuals who can read and comprehend the English language. 
 
ExclusionCriteria 
Details  Individuals under the age of 18.
Adults with medical conditions that prevent them from engaging in physical activity.
Individuals who cannot read and comprehend the English language.
Individuals who do not provide informed consent.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The outcome measures in this study will be used to evaluate the usefulness
and associations between the independent and dependent variables.  
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To know the Health-Related Quality of Life among adults who have low, moderate and high levels of physical activity, stress and sleep quality respectively and the interplay between each  Baseline 
 
Target Sample Size   Total Sample Size="693"
Sample Size from India="693" 
Final Enrollment numbers achieved (Total)= "694"
Final Enrollment numbers achieved (India)="694" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/12/2024 
Date of Study Completion (India) 25/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Aim: 
To evaluate the impact of Physical activity, stress, and sleep quality on Health-Related Quality of Life (HRQoL) among adults. 

Objectives: 
1) To examine the relationship between physical activity and Health-Related Quality of Life. 

 2) To analyze the effect of stress on Health-Related Quality of Life. 

 3) To explore the connection between sleep quality and health-related quality of life. 

 4) To assess the combined effect of Physical activity, stress, and sleep quality on Health-related quality of life. 

Procedure: 

1) This study will adopt a cross-sectional study design utilizing a survey method. The study protocol will be submitted for approval to the Institutional Ethics Committee (IEC). Participant Recruitment and Informed Consent: Study Participants will be selected using convenience sampling and contacted via social media platforms and messaging apps such as WhatsApp, SMS, and email. These primary respondents will be encouraged to share the survey with their contacts (secondary respondents). 

2) Adults over 18 who are willing to participate will be considered for the study. The study will include participants who are able to read and understand the English language. 

3) Detailed information about the study, including its objectives, procedures, and potential risks and benefits, will be provided to all participants. Those who agree to participate will receive a link to the survey, hosted as a Google Form. The first page of the survey will include a consent form detailing the study. Only participants who provide informed consent will proceed to the questionnaire using standardized tools with permission from the respective authors. 

4) Responses will be recorded through a self-reporting questionnaire. 
Data Collection - Demographic Information: Participants will be asked to provide basic demographic information such as age, gender, and educational status. 

5) Further, Standardized Questionnaires will include IPAQ, PSS-10, PSQI and SF-36. 

6) Data Analysis: The quantitative data collected through standardized questionnaires will be analyzed using appropriate statistical methods. 

Background: Health-Related Quality of Life (HRQoL) is a comprehensive measure of an individual’s overall well-being, encompassing physical, mental, and social aspects of health. In today’s fast-paced world, lifestyle factors such as physical activity, stress levels, and sleep quality play a significant role in shaping HRQoL. Physical activity is widely recognized as a cornerstone of good health, reducing the risk of chronic diseases and improving mental health. On the other hand, stress, especially when chronic, can negatively impact both physical and psychological health, contributing to issues like anxiety, depression, and poor cardiovascular health. Sleep quality, an often-overlooked factor, directly affects cognitive function, emotional stability, and physical recovery. Despite the known importance of these factors, their combined impact on HRQoL remains underexplored, particularly among adults in diverse settings. Understanding these relationships is critical, as adults often face unique challenges balancing work, personal life, and health, making them susceptible to poor HRQoL. 

Purpose: Modern sedentary lifestyles, characterized by reduced physical activity, rising stress levels, and disrupted sleep, significantly deteriorate overall health. This decline is increasingly reflected in the focus on Health-Related Quality of Life (HRQoL) studies. Regular physical activity improves health outcomes. Emphasizing these benefits can encourage individuals to exercise regularly and maintain long-term physical activity routines. Assessing the effects of stress and sleep quality on HRQoL is crucial for developing effective stress reduction strategies and promoting healthy sleep practices, which are vital for preventive health. Despite established links between these factors and HRQoL, research often examines them individually rather than their combined impact across diverse adult populations. This study aims to fill this gap by exploring how physical activity, stress, and sleep quality influence HRQoL, aiding in developing holistic health interventions and benefiting society.
 
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