| CTRI Number |
CTRI/2026/01/100724 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on how the body clock, body composition and breathing are connected in young adults |
|
Scientific Title of Study
|
Association of circadian rhythm, body composition and breathing pattern among young 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 |
SUSHMITHA R |
| Designation |
BPT UG Student |
| Affiliation |
SRM College of Physiotherapy |
| Address |
SRM College of Physiotherapy
5th floor SRM Medical College Hospital and Research Centre Potheri SRM Nagar
Kattankulathur Tamil Nadu
Kancheepuram TAMIL NADU 603203 India |
| Phone |
9345126896 |
| Fax |
|
| Email |
sr8540@srmist.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
KAVIYA M |
| Designation |
Assistant Professor |
| Affiliation |
SRM College of Physiotherapy |
| Address |
SRM College of Physiotherapy
5th floor SRM Medical College Hospital and Research Centre Potheri SRM Nagar
Kattankulathur Tamil Nadu
Kancheepuram TAMIL NADU 603203 India |
| Phone |
9940513772 |
| Fax |
|
| Email |
kaviyam3@srmist.edu.in |
|
Details of Contact Person Public Query
|
| Name |
KAVIYA M |
| Designation |
Assistant Professor |
| Affiliation |
SRM College of Physiotherapy |
| Address |
SRM College of Physiotherapy
5th floor SRM Medical College Hospital and Research Centre Potheri SRM Nagar
Kattankulathur Tamil Nadu
Kancheepuram TAMIL NADU 603203 India |
| Phone |
9940513772 |
| Fax |
|
| Email |
kaviyam3@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy, 5th floor SRM Medical College Hospital and Research Centre, Pillayar koil street, Potheri, SRM Nagar, Kattankulathur, Tamil Nadu, India 603203 |
|
|
Primary Sponsor
|
| Name |
SUSHMITHA R |
| Address |
SRM College of Physiotherapy
5th floor SRM Medical College Hospital and Research Centre Potheri SRM Nagar Kattankulathur Tamil Nadu 603203 |
| 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 |
| Dr KAVIYA M |
SRM College of Physiotherapy, SRM Institute of Science and Technology |
Room no. 14, SRM College of Physiotherapy, 5th floor SRM Medical College Hospital and Research Centre, Pillayar koil street, Potheri, SRM Nagar, Kattankulathur, Tamil Nadu 603203 Kancheepuram TAMIL NADU |
9940513772
kaviyam3@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Centre of SRM University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Going to check circadian rhythm, body composition and breathing pattern |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
College students aged between 18-25 years.
Both male and female participants
Willing to participate, give informed consent and follow instructions.
|
|
| ExclusionCriteria |
| Details |
Known history of respiratory, metabolic, neurological, psychological or musculoskeletal disorder.
Recent thoracic or abdominal surgery.
Use of sedatives, corticosteroids, or hormonal therapy influencing sleep, metabolism, or respiration.
Acute respiratory infection in the past 4 weeks.
Working in night shifts.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Determine the association of circadian rhythm, body composition, and breathing pattern among young adults.
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the circadian rhythm among young adults.
2.To evaluate body composition parameters among young adults.
3.To analyze breathing patterns among young adults.
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="121" Sample Size from India="121"
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)
|
20/01/2026 |
| 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="3" Days="1" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response (Others) - Data collection sheet
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response (Others) - Complete data
- By what mechanism will data be made available?
Response (Others) - Repository
- For how long will this data be available start date provided 20-12-2025 and end date provided 20-12-2029?
Response (Others) - Always
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a cross sectional study observational trial on Association of circadian rhythm, body composition and breathing pattern among young adults that will be conducted in SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur, Tamil Nadu, India. The primary outcome is to determine the association of circadian rhythm, body composition, and breathing pattern among young adults. The secondary outcomes to evaluate the circadian rhythm among young adults, To evaluate body composition parameters among young adults and to analyze breathing patterns among young adults. Informed
consent will be taken from all participants, who will be selected based on
inclusion and exclusion criteria followed by demographic data collection. The Morningness–Eveningness Questionnaire Self- Report Version (MEQ-REV-SR) will be administered to determine participants. Baseline details will be recorded. Bioelectrical
Impedance Analysis (BIA) is
used to analyse body composition of the participant. Results will be recorded
and explained to participants. Hi–Lo
Test: The movement
of the chest and abdomen during normal breathing will be observed to identify
whether the breathing pattern is diaphragmatic or dysfunctional. All
collected data will be recorded and analyzed statistically using SPSS. |