| CTRI Number |
CTRI/2026/02/103151 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Can Strength Training Boost Mental Well-Being and Heart Health? A Study Using Salivary Markers |
|
Scientific Title of Study
|
Analysing the Impact of Resistance Training on Psychological Health, Quality of Life, and Atherosclerosis Using Salivary Biomarkers among Early Middle Aged Individuals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
kilani Kusuma |
| Designation |
PhD scholar |
| Affiliation |
Meenakshi Academy Of Higher Education And Research |
| Address |
Meenakshi Academy of Higher Education and Research
12 Vembuliamman Koil Street Annaji Nagar KK Nagar West KK Nagar, Chennai, Tamil Nadu 600087
Chennai
TAMIL NADU
600087
India |
| Phone |
09866395084 |
| Fax |
|
| Email |
kilani_res@maher.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.P.V.Hari Hara Subramanyan |
| Designation |
Associate professor |
| Affiliation |
Meenakshi Academy Of Higher Education And Research |
| Address |
Meenakshi Of Physiotherapy, Meenakshi Academy Of Higher Education and Research, KK NAGAR 600078
Chennai
TAMIL NADU
600002
India |
| Phone |
9444840543 |
| Fax |
|
| Email |
hari@maherfpt.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
kilani Kusuma |
| Designation |
PhD scholar |
| Affiliation |
Meenakshi Academy Of Higher Education And Research |
| Address |
Faculty Of Physiotherapy, Meenakshi Academy Of Higher Education And Research KK NAGAR 600078
Chennai
TAMIL NADU
600002
India |
| Phone |
09866395084 |
| Fax |
|
| Email |
kilani_res@maher.com |
|
|
Source of Monetary or Material Support
|
| MEENAKSHI ACADEMY OF HIGHER EDUCATION and RESEARCH
Vembuliamman Koil Street, West KK Nagar, Chennai, Tamil Nadu, India 600 078 |
|
|
Primary Sponsor
|
| Name |
KILANI KUSUMA |
| Address |
12, Vembuliamman Koil St, Annaji Nagar, KK Nagar West, K. K. Nagar, Chennai, Tamil Nadu 600087 |
| 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 |
| kilani Kusuma |
Meenakshi Academy of Higher Education and Research and its Constituent Colleges |
Department of Physiotherapy,
Faculty of Allied Health Sciences,
Room No. 1
Chennai
TAMIL NADU |
09866395084
kilani_res@maher.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Meenakshi Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
apparently healthy participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
HEART health education program with no exercise intervention for 12 weeks(3months) |
12 Weeks Weekly Once 3 Months
Key Points Covered
Week 1
Understanding Mental Wellbeing
Introduction to mental health self awareness emotional check ins and stigma reduction
Week 2
Stress Management Techniques
Recognizing stress triggers deep breathing journaling and guided imagery
Week 3
Sleep Hygiene
Importance of sleep sleep cycle basics tips for quality sleep and creating a sleep friendly environment
Week 4
Healthy Eating for the Mind
Impact of nutrition on mood brain foods mindful eating and hydration
Week 5
Social Health and Relationships
Importance of social connections communication skills empathy and setting boundaries
Week 6
Time and Routine Management
Structuring your day using planners reducing procrastination and balancing work life
Week 7
Coping with Anxiety
What is anxiety identifying symptoms grounding techniques and calming activities
Week 8
Building Self Esteem
Understanding self worth positive affirmations and body image positivity
Week 9
Avoiding Burnout
Signs of burnout energy conservation work rest balance and saying no when needed
Week 10
Digital Wellness
Screen time awareness impact of social media digital detox ideas and sleep tech balance
Week 11
General Health Awareness
Preventive health checks importance of hydration oral and skin hygiene and reducing substance use
Week 12
Recap and Goal Setting
Review of previous topics individual goal discussion health journaling and motivation techniques |
| Intervention |
resistance training FOR 12 WEEKS, TWICE WEEKLY (3 months) |
1.chest press 2.push up 3.shoulder press 4.shoulder raise.5.Seated row 6.triceps extension 7.biceps curl 8.squat 9.abdominal crunch 10.back extension. |
|
|
Inclusion Criteria
|
| Age From |
34.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged between 34 and 45 years old with less interpersonal communication.
Individuals who are having long working hours according to the self-framed proforma.
Individuals with irregular sleep patterns and poor sleep quality as per self-framed proforma.
Appeared healthy and had no impediments such as motor limitations with upper and lower extremities.
Subjects had no history of cardiopulmonary diseases and chronic illness.
|
|
| ExclusionCriteria |
| Details |
Individuals who suffer from oral pathology.
Individuals who suffer from periodontitis.
Individuals who have adenoiditis.
Individuals suffering with tonsillitis.
Individuals who have tongue thrust.
Individuals who have snoring.
Individuals who suffer from temporal mandibular problems.
Individuals who have recurrent apthous stomatitis.
Individuals having disorders of the V, VII, and IX cranial nerves.
Currently taking psychotropic or anti-inflammatory drugs.
Those with a BMI of 30 or higher.
Individuals who have high blood pressure.
Individuals who suffer from autoimmune or chronic inflammatory diseases.
Pregnancy.
It had been six months since they last engaged in isokinetic resistance training
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in IL-6 and CRP levels from baseline (1st week) to post-intervention at 12th week. |
Pre-test at baseline (1st week) and post-test at the end of 12 weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in stress levels & quality of life from baseline (1st week) to the end of the intervention (12th week).
|
Baseline (1st week) & 12 weeks.
|
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/02/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
|
Trial Progress Summary:
Participant recruitment for the study has been successfully completed as per the approved sample size from 5 different working organizations. apparently healthy individuals were recruited. All enrolled participants have undergone the planned intervention, and the study is currently in the final phase of intervention completion. No major protocol deviations or adverse events have been reported during the study period. Data collection through salivary biomarkers, psychological health scales, quality of life questionnaires, and atherosclerosis-related measures has been completed for the majority of participants, with final follow-up assessments underway. The study is progressing as per the approved timeline, and overall trial completion is expected shortly upon completing the remaining assessments and beginning data analysis. All procedures are being conducted according to the CTRI-approved protocol and ethical guidelines. | Category | Details | | Total Approved Sample Size | 100 participants | | Total Recruited Participants | 100 participants | | Experimental Group | 50 participants | | Control Group | 50 participants | | Intervention Status – Experimental Group | Completed 21 out of 24 sessions | | Intervention Status – Control Group | Completed 12-week health education program | | Recruitment Status | Completed | | Retention Rate | 100% (No dropouts reported) | | Major Issues Faced | No major issues reported. Minor challenge: difficulty gathering participants at one place. | | Expected Date of Overall Study Completion | December 25th, 2025 | | Adherence to Protocol | Within acceptable limits; no significant deviations. | |