| CTRI Number |
CTRI/2025/05/086537 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
12/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Relationship among Cardiorespiratory Fitness, Selected Neurochemical and Cardio Autonomic Markers in Healthy Young Adults - A Cross Sectional Study |
|
Scientific Title of Study
|
Impact of Cardiorespiratory Fitness On Selected Neurochemical and Cardio Autonomic Markers |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dilip Roy |
| Designation |
Ph.D Scholar |
| Affiliation |
Jadavpur University |
| Address |
Department of Physical Education, Jadavpur University, Kolkata
Kolkata
WEST BENGAL
700032
India |
| Phone |
9679157430 |
| Fax |
|
| Email |
dilipr.pe.rs@jadavpuruniversity.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sridip Chatterjee |
| Designation |
Guide/Associate Professor |
| Affiliation |
Jadavpur University |
| Address |
Department of Physical Education, Jadavpur University, Kolkata
Kolkata
WEST BENGAL
700032
India |
| Phone |
9674764085 |
| Fax |
|
| Email |
sridipchatterjee.ped@jadavpuruniversity.in |
|
Details of Contact Person
Public Query
|
| Name |
Dilip Roy |
| Designation |
Ph.D Scholar |
| Affiliation |
Jadavpur University |
| Address |
Department of Physical Education, Jadavpur University, Kolkata
Kolkata
WEST BENGAL
700032
India |
| Phone |
9679157430 |
| Fax |
|
| Email |
dilipr.pe.rs@jadavpuruniversity.in |
|
|
Source of Monetary or Material Support
|
| Jadavpur University
188 Raja SC Mullick Road, Jadavpur 700032 |
|
|
Primary Sponsor
|
| Name |
Jadavpur University |
| Address |
188, Raja Subodh Chandra Mallick Rd, Jadavpur, Kolkata, West Bengal 700032 |
| Type of Sponsor |
Other [Academic and Research State University] |
|
|
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 |
| Dilip Roy |
Exercise and Sports Physiology Laboratory, Department of Physical Education, Jadavpur University |
188 Raja SC Mullick Road, Jadavpur Kolkata 700032
Kolkata
WEST BENGAL |
09679157430
dilipr.pe.rs@jadavpuruniversity.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jadavpur University |
Approved |
| NOC from Laboratory |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Physical Education Students within the age group of 20-30 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Male |
| Details |
Only healthy males aged 20-30 years having at least 4 years training age. |
|
| ExclusionCriteria |
| Details |
Males under went any medical issues were excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Researcher expects the following deliverables from the study:
1. Identification of association of cardiorespiratory fitness with selected neurochemicals.
2. To realize the effect of cardiorespiratory fitness with selected cardio autonomic markers.
|
One time Assessment - at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| On the basis of the scientific observation we may recommend chronic exercise training which may positively influence cardio autonomic markers & brain health. |
Data will be sought one time only at baseline.. |
|
|
Target Sample Size
|
Total Sample Size="115"
Sample Size from India="115"
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)
|
10/05/2025 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
@OZ4 |