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CTRI Number  CTRI/2024/11/076275 [Registered on: 05/11/2024] Trial Registered Prospectively
Last Modified On: 04/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Qualitative study 
Study Design  Other 
Public Title of Study   Barriers and facilitators of physical activity among older adults 
Scientific Title of Study   Barriers and Strategies for Promotion of Physical Activity Among Older Adults in South India- A Qualitative Study Using Focus Group Discussions with Stakeholders 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kavitha Vishal 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Assistant Professor Department of Physiotherapy Manipal college of Health Professions Manipal Academy of Higher education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  09986526077  
Fax    
Email  kavitha.vishal@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Kavitha Vishal 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Assistant Professor Department of Physiotherapy Manipal college of Health Professions Manipal Academy of Higher education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  09986526077  
Fax    
Email  kavitha.vishal@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Kavitha Vishal 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Assistant Professor Department of Physiotherapy Manipal college of Health Professions Manipal Academy of Higher education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  09986526077  
Fax    
Email  kavitha.vishal@manipal.edu  
 
Source of Monetary or Material Support  
British journal of Sports medicine 
British Journal of Sports Medicine Editorial OfficeBMA HouseTavistock SquareLondon, WC1H 9JRUK 
 
Primary Sponsor  
Name  British Journal of Sports Medicine  
Address  British Journal of Sports Medicine Editorial Office BMA HouseTavistock Square London, Pin code: WC1H 9JRUK 
Type of Sponsor  Other [Journal] 
 
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 Kavitha Vishal  Kasturba Hospital,Manipal  Room no: 4 , N1 OPD , Department of Physiotherapy
Udupi
KARNATAKA 
09986526077

kavitha.vishal@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  Older Adults 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Older adults residing in the community
Health care providers involved in the care of older adults  
 
ExclusionCriteria 
Details  Cognitive impairments
Serious medical illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Themes generated from qualitative interviews  Baseline ONLY 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  nil 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   15/11/2024 
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="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  

Study Design and Methodology: This project will employ a qualitative research design with focus group discussions to gain in-depth perspectives on the barriers and facilitators for PA among older adults in India. Two distinct groups will be recruited.

Focus Group 1 - Health Care Professionals (HCPs): A diverse group of potential participants will be recruited from a tertiary care medical college hospital including (but not limited to) general medicine practitioners, geriatric specialists, physiotherapists, occupational therapists, and rehabilitation experts involved in caring for the older adults. The discussion probes will be directed to challenges faced while prescribing PA, strategies to integrate and encourage PA into their prescription, role of healthcare providers in promoting PA. Focus group 2 - Older adults: Older adults aged 60 and above will be recruited using a purposive sampling approach to ensure diversity in age, sex, socioeconomic background, and environmental location. Potential participants will be identified through collaboration with local community centres and old age homes. Additional snowball sampling will be used to further recruit participants. To be eligible, participants must have not had significant cognitive impairment. The discussions will delve into personal experiences and perspectives on PA, the importance of engaging in PA, the values of PA in the community, perceived barriers/motivators, and strategies to promote PA in older adults with limited resources.

Data collection: We will conduct two rounds of FGDs. In the first round, FGD will be conducted separately for HCPs, and older adults to ensure an open environment for discussions. Each group will consist of 8-12 participants to engage diverse perspectives. In the second round, we will conduct FGDs with a combined group of HCPs and older adults to further share and discuss the potential views that emerged in the first round.

Procedure: A facilitator trained in qualitative research methods and a note-taker will conduct the focus group discussions. The facilitator will guide the group discussions using a semi-structured interview guide that is tailored to each participant group. The facilitator will encourage open dialogue and ensure all the participants have the opportunity to share their experiences and viewpoints. The note-taker will record the comments and interpersonal interactions during the interview without intervening. The interview guide will consist of open-ended questions regarding barriers and facilitators, experiences, and strategies for adherence, sociocultural and environmental determinants of PA, and will be formulated using theoretical domains framework (TDF).6 The discussions are expected to last approximately 60-90 mins for each session and will be conducted in a quiet environment ensuring the confidentiality and comfort of all the participants.

  

Data analysis: Thematic content analysis will be employed to analyse the data. All the FGDs will be audio-recorded and transcribed verbatim. Transcripts will be read several times for accuracy and any identifying information will be anonymized. Initially, two researchers will independently read and code the transcripts to identify emerging themes related to PA in older adults. The researchers will then meet to discuss and refine the identified themes, achieving consensus through discussions. 

Data triangulation:  Data triangulation will be performed by comparing and contrasting the themes arising from the FGDs with those from the different participant groups (HCPs and older adults) strengthening the validity of the findings. 

 
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