| CTRI Number |
CTRI/2025/12/099748 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| 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
|
Impact of High Intensity Interval Training on changing the Risk of type 2 diabetes and abdominal Obesity in Young People |
|
Scientific Title of Study
|
Effect of High Intensity Interval Training on modifying the risk to develop type 2 Diabetes and abdominal obesity among young adults: an Experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhwani Rajesh Kothari |
| Designation |
PG student |
| Affiliation |
Associate Professor |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy, Block J, Raghunath Vihar, Sector 14, Kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9324954481 |
| Fax |
|
| Email |
kdhwani53@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hiranmayee Bagwe |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy, Block J, Raghunath Vihar, Sector 14, Kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9699969313 |
| Fax |
|
| Email |
hiranmayee.bagwe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hiranmayee Bagwe |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy, Block J, Raghunath Vihar, Sector 14, Kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9699969313 |
| Fax |
|
| Email |
hiranmayee.bagwe@gmail.com |
|
|
Source of Monetary or Material Support
|
| TMVs Lokmanya Tilak College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy, Block J, Raghunath Vihar, Sector 14, Kharghar- 410210 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| TMVs Lokmanya Tilak College of Physiotherapy |
TMVs Lokmanya Tilak College of Physiotherapy, Block J, Raghunath Vihar, Sector 14, Kharghar- 410210 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dhwani Rajesh Kothari |
TMVs Lokmanya Tilak College of Physiotherapy |
Cardiovascular and Respiratory Physiotherapy, Third floor, Department of ,J Block , Raghunath Vihar, Sector 14, Kharghar, Navi Mumbai- 410210
Raigarh
MAHARASHTRA |
9324954481
kdhwani53@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMVs Lokmanya Tilak College of Physiotherapy Institutional Ethics Committee Academic |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age 18-25 YEARS , Male AND Female both at Medium TO High Risk to develop T2DM |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High Intensity Interval Training
|
pre intervention - IDRS , IPAQ and waist circumference will be evaluated. 6 weeks of supervised stair climbing protocol 3 days per week. pre-vitals (HR, RPE , BP) will be taken followed by warm up - walk at a self-selected brisk pace. intervention will consist of 20sec bout of ascending stairs for 3 repetitions with a 2 minute recovery period between each repetitions, post intervention , cool down including down stairs followed by post vitals(HR,RPE,BP) will be taken. post intervention IDRS, IPAQ and waist circumference will be re-evaluated . |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Medium and high- risk young adults (according to IDRS)
2.18-25 years young adults
3.Individuals who are willing to participate
4.Both males and females
|
|
| ExclusionCriteria |
| Details |
1.Individuals diagnosed with cardiovascular, respiratory, or psychological disorders.
2.Neurological and/or musculoskeletal conditions
3.Lower limb injury/deformity OR any medical conditions which hampers the participants to perform the protocol
4.Acute illness (fever, weakness, cold and cough)
5.Diagnosed with peripheral vascular disease
6.Individuals with diagnosed metabolic disorder (T1Diabetes/T2DM/ pre-Diabetes)
7.Individuals diagnosed with congenital neuro-musculoskeletal & cardiac conditions
8.Recent major surgeries (1 month)
9.Individual who are unable to perform stair climbing
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.IDRS for checking the risk to develop type 2 diabetes
2.IPAQ for assessing the level of physical activity
3.Waist circumference for assessing the abdominal obesity |
6 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
15/04/2026 |
| 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="5"
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
|
Study is experimental (non-randomized trial) ,conducted for 6 months on young adults (18-25 years) who are at a medium or high risk of developing type 2 diabetes according to Indian Diabetes Risk Score. outcome measures includes Indian Diabetes Risk Score IPAQ to assess for physical activity , waist circumference to assess abdominal obesity |