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CTRI Number  CTRI/2024/11/077065 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 18/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparing Physical Activity and Quality of Life in Rural and Urban Elderly. 
Scientific Title of Study   A STUDY TO COMPARE PHYSICAL ACTIVITY LEVEL AND QUALITY OF LIFE AMONG ELDERLY IN RURAL AND URBAN POPULATIONS 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinuta Harpanhalli 
Designation  Assistant Professor 
Affiliation   
Address  Advanced physiotherapy Center,Room No. 39, Sagar Floor,Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA 590010 India Belgaum KARNATAKA

Belgaum
KARNATAKA
590010
India 
Phone  9714334270  
Fax    
Email  harapanhallivinuta97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vinuta Harpanhalli 
Designation  Assistant Professor 
Affiliation   
Address  Advanced physiotherapy Center,Room No. 39, Sagar Floor,Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA 590010 India Belgaum KARNATAKA

Belgaum
KARNATAKA
590010
India 
Phone  9714334270  
Fax    
Email  harapanhallivinuta97@gmail.com  
 
Details of Contact Person
Public Query  
Name  Tanmayee Mahesh Shetty 
Designation  Physiotherapy Intern 
Affiliation  KLE Institute of Physiotherapy Belagavi 
Address  Advanced physiotherapy Center,Room No. 39, Sagar Floor,Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA 590010 India
PNP ladies Hostel, Nehru Nagar JNMC campus
Belgaum
KARNATAKA
590010
India 
Phone  9545604845  
Fax    
Email  shettytanmayee@gmail.com  
 
Source of Monetary or Material Support  
Self Sponsored 
 
Primary Sponsor  
Name  Self Sponsored 
Address  Self Sponsored 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Tanmayee Shetty  Rural Areas  rural areas of Sambra, Balekundri, Shindoli, Nilaji of Belgaum taluka
Belgaum
KARNATAKA 		 9545604845

shettytanmayee@gmail.com 
Tanmayee Shetty  Urban Areas  Nehru Nagar, Sadashiv Nagar,Shivbasav Nagar, Mahantesh Nagar, Shivaji Nagar, Gandhi Nagar, Mahantesh Nagar, Hanuman Nagar, Azam Nagar, of Belgaum city
Belgaum
KARNATAKA 		 9545604845

shettytanmayee@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research And Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Participants aged 60 years and above of both male and female genders, Individuals residing in rural areas of Sambra, Balekundri, Shindoli, Nilaji of Belgaum taluka and residing for atleast 5 years and above.Individuals residing in urban areas of Nehru Nagar, Sadashiv Nagar,Shivbasav Nagar, Mahantesh Nagar, Shivaji Nagar, Gandhi Nagar, Mahantesh Nagar, Hanuman Nagar, Azam Nagar, of Belgaum city and residing for at least 5 years and above.Ability to provide consent. 
 
ExclusionCriteria 
Details  Diagnosed cases of cognitive impairment or terminal illnesses.Any post operative cases within the last month.Individuals confined to bed. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
WHOQOL-BREF , Physical Activity Scale for the Elderly (PASE)  WHOQOL-BREF , Physical Activity Scale for the Elderly (PASE) 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="196"
Sample Size from India="196" 
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)   30/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/11/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

l IN RURAL AREA

Ø Ethical clearance will be obtained by the Institutional Ethical Committee.

Ø CTRI registration will be done.

Ø Subjects will be divided into two groups i.e., rural and urban residents.

Ø The study will be carried out in rural areas located at Sambra, Balekundri, Shindoli, Nilaji in Belgaum Taluka residing for at least 5 years and above.

Ø Prior permission will be taken from the Village Panchayat to conduct the study.

Ø Subjects will be informed about the purpose and procedure of the study in their vernacular language.

Ø A written consent form will be obtained from the participants.

Ø Demographic data will be obtained from the participants prior to the assessment.

Ø WHOQOL- BREF Questionnaire and PASE Questionnaire will be handed to the participants.

Ø Each participant will be given the questionnaires to be filled or will be filled by the researcher in case the participant has difficulty in interpretation and the same will be conveyed to the participant in their vernacular language.

Ø Once the questionnaire is completed, the responses will be calculated.

Ø The data received will be documented and analyzed.


l IN URBAN AREA

Ø Ethical clearance will be obtained by the Institutional Ethical Committee.

Ø CTRI registration will be done.

Ø Subjects will be divided into two groups i.e., rural and urban residents.

Ø The study will be carried out in urban areas namely  Nehru Nagar, Sadashiv Nagar, Shivbasava Nagar, Mahantesh Nagar, Shivaji Nagar, Gandhi Nagar, Mahantesh Nagar, Hanuman Nagar, Azam Nagar, of Belgaum City and residing for at least 5 years and above.

Ø Prior permission will be taken from the Village Panchayat to conduct the study.

Ø Subjects will be informed about the purpose and procedure of the study in their vernacular language.

Ø A written consent form will be obtained from the participants.

Ø Demographic data will be obtained from the participants prior to the assessment.

Ø WHOQOL- BREF Questionnaire and PASE Questionnaire will be handed to the participants.

Ø Each participant will be given the questionnaires to be filled or will be filled by the researcher in case the participant has difficulty in interpretation and the same will be conveyed to the participant in their vernacular language.

Ø Once the questionnaire is completed, the responses will be calculated.

Ø The data received will be documented and analyzed.

 
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