| 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
|
|
|
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
|
|
|
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. |