| CTRI Number |
CTRI/2025/05/086561 [Registered on: 08/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To study the effect of motivation(aromatherapy and peer presence) on exercise on healthy Young adults |
|
Scientific Title of Study
|
Evaluation of motivation driven exercise among healthy adults:- A Randomized Controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SWATI KUMARI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GSVM Medical College Kanpur |
| Address |
DEPARTMENT OF PHYSIOLOGY G.S.V.M Medical College Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
7905887411 |
| Fax |
|
| Email |
swatianand1957@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Kanawjia |
| Designation |
Associate professor |
| Affiliation |
GSVM Medical College Kanpur |
| Address |
DEPARTMENT OF PHYSIOLOGY G.S.V.M Medical College Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9125330717 |
| Fax |
|
| Email |
drpreeti2411@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SWATI KUMARI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GSVM Medical College Kanpur |
| Address |
DEPARTMENT OF PHYSIOLOGY G.S.V.M Medical College Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
7905887411 |
| Fax |
|
| Email |
swatianand1957@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self(Swati Kumari junior Resident Department of Physiology GSVM Medical College Kanpur Uttar Pradesh India 277208) |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
G.S.V.M Medical College Kanpur U.P. 208002 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| SWATI KUMARI |
GSVM MEDICAL COLLEGE KANPUR |
Human Clinical Lab room number 6 DEPARTMENT OF PHYSIOLOGY
Kanpur Nagar
UTTAR PRADESH |
7905887411
swatianand1957@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE G.S.V.M Medical College Kanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY INDIVIDUALS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aromatherapy |
Participants will be exposed to aroma of essential oil with the help of a diffuser |
| Comparator Agent |
Verbal/peer presence |
Participants will be motivated verbally by their peers |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
Informed consent, Enrolled in medical courses,Well nourished, Sedentary not doing regular exercise, Apparantly clinically healthy subjects |
|
| ExclusionCriteria |
| Details |
inability to follow up,any addiction(tobacco/ alcohol),Pregnant females,Psychiatric illness, Musculoskeletal Cardio-respiratory & neural disorder,Specially abled,Intake of routine multivitamins,Chronic medical illness,Any condition which in view of investigator maybe a limiting factor in performing exercise |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate motivation driven exercise performance in healthy subjects |
after the first intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| exercise performance will be better and salivary cortisol levels will be decreased in aromatherapy group as compared to non aromatherapy group |
after the first interventions |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/05/2025 |
| 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="1"
Months="0"
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
|
This is a Randomized controlled trial which we are doing to evaluate effect of motivation(intrinsic/extrinsic) on exercise performance of a healthy individual.After an educational session imparted to participants about benefits of regular exercise, subjects of either group will be made to perform running on a treadmil till exhaustion in a well conditioned quiet room but before that pre testing of parameters(Heart rate,Respiratory Rate,Pulse Rate,Blood Pressure,Oxygen saturation).We ar expecting that there’s additive and/or synergistic effect of merging the motivational tools on one’s physical performance. |