| 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
|
|
|
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
|
|
|
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. |