| CTRI Number |
CTRI/2026/04/107890 [Registered on: 08/04/2026] Trial Registered Prospectively |
| Last Modified On: |
07/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How Lifestyle and Health Knowledge Affect Swallowing in Older Adults |
|
Scientific Title of Study
|
Association Between Physical Activity & Health Literacy with Self-Perceived Dysphagia in Community Dwelling Older 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 |
Kaveri C |
| Designation |
Student |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
Department of Speech and Hearing, MCHP, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8754936897 |
| Fax |
|
| Email |
kaveri.mchpmpl2025@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Devadas |
| Designation |
Professor & HOD |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
Department of Speech and Hearing, MCHP, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448930882 |
| Fax |
|
| Email |
usha.d@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Janet Jaison Varghese |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
Department of Speech and Hearing, MCHP, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7045385800 |
| Fax |
|
| Email |
janet.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kaveri c |
| Address |
Department of Speech and Hearing, MCHP, Madhav Nagar, Manipal 576104,Karnataka, India |
| 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 |
| Ms Kaveri C |
Manipal College of Health Professions |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nager, Manipal
Udupi
KARNATAKA |
8754936897
kaveri.mchpmpl2025@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee of Kasturba Medical College and Hospital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Community Dwelling Older Adults aged 60 to 80 years |
|
|
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 |
1. Male and female community dwelling older adults aged 60 to 80 years.
2. Able to read and understand Kannada language
|
|
| ExclusionCriteria |
| Details |
1. Individuals with a history of neurological disorder (e.g., stroke, Parkinson’s disease, dementia, motor neurone disease (MND), or Multiple sclerosis)
2. Individuals with known psychiatric illnesses (e.g., major depression, schizophrenia, or other severe mental health conditions that may affect participation)
3. Individuals with medical conditions known to influence swallowing or physical activity (e.g., chronic respiratory diseases, chronic renal failure, or head and neck cancers).
4. Individuals with severe cognitive deficits.
5. Individuals who are bedridden, institutionalised, or currently undergoing dysphagia therapy or rehabilitation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The level of dysphagia will be measured by using EAT-10.
The health literacy level will be measured by using HLS-IND-KAN 16.
The level of physical activity will be measured by using GPAQ. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/04/2026 |
| 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="1"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Summary of Review
Physical activity and physical performance showed an
inverse association with dysphagia and oropharyngeal dysfunction, indicating that
higher level of exercise and better physical performance are linked to lower risk of dysphagia in older adults. Similarly,
health literacy demonstrated an inverse association with dysphagia, with lower
health literacy levels associated with a higher risk of swallowing difficulties
among older adults. Together these findings indicate that physical activity and
health literacy play crucial roles in preventing dysphagia among older adults.
Higher activity levels are linked to better muscle strength, swallowing
function, and quality of life, while low health literacy is linked with greater
dysphagia risk and delayed care-seeking. Research gap Dysphagia is increasingly recognized as a prevalent and clinically
significant problem among community-dwelling older adults worldwide. Few
Western studies have demonstrated that physical activity and health literacy
play a crucial role in the prevention and management of dysphagia in older
adults. However, no such studies have been reported from India. Need for the study
Patterns of physical activity, literacy levels, and health behaviors
among older adults in India may differ substantially from those observed in
Western population. Understanding how physical activity and health literacy
interact to affect self-perceived dysphagia in older adults in India is
essential for designing targeted, community-based screening, education, and
preventive programs that can enhance swallowing health and promote healthy
aging. Outcome
measures:
·
The
level of dysphagia symptoms will be
measures by using EAT-10.The health literacy level will be measured by using
HLS-IND-KAN 16. The
level of physical activity will be measures by using GPAQ. |