| CTRI Number |
CTRI/2025/06/088505 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
High intensity interval training vs low intensity interval training which is more effective for reducing obesity in college students |
|
Scientific Title of Study
|
Comparsion Effect of High Intensity Interval Training Vs Low Intensity Interval Training On Obesity Reduction In College Students |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjogita Choudhary |
| Designation |
Postgraduate Student |
| Affiliation |
The Oxford College of Physiotherapy |
| Address |
The Department of Musculoskeletal sciences-Physiotherapy,No.6/9A, 1st cross Begur road, Hongasandra , Bengaluru - 560068
Bangalore
KARNATAKA
560068
India |
| Phone |
09686790340 |
| Fax |
|
| Email |
sanjogita1699@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rucha Bhaskarwar |
| Designation |
Professor |
| Affiliation |
The Oxford College of Physiotherapy |
| Address |
The Department of Musculoskeletal sciences-Physiotherapy,No.6/9A, 1st cross Begur road, Hongasandra , Bengaluru - 560068
Bangalore
KARNATAKA
560068
India |
| Phone |
9960809575 |
| Fax |
|
| Email |
dr.richa29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Vasanthan |
| Designation |
Principal |
| Affiliation |
The Oxford College of Physiotherapy |
| Address |
The Department of Musculoskeletal sciences-Physiotherapy,No.6/9A, 1st cross Begur road, Hongasandra , Bengaluru - 560068
Bangalore
KARNATAKA
560068
India |
| Phone |
09916919685 |
| Fax |
|
| Email |
physiotherapyprincipal@theoxford.edu |
|
|
Source of Monetary or Material Support
|
| 1.The Oxford College of Physiotherapy , No.6/9A,1st cross, Begur road,Hongasandra,Bengaluru-560068
2.Oxford College of Nursing and Sciences, No.6/9A,1st cross,Begur road, Hongasandra, Bengaluru - 560068 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tirumala Rao |
Oxford College of Nursing Sciences |
No.6/9A, 1st cross Begur road, Hongasandra , Bengaluru - 560068
Bangalore
KARNATAKA |
7829604865
tirumalarao64@gmail.com |
| DrTirumala Rao |
The Oxford College Of Physiotherapy |
The Department of Musculoskeletal sciences-Physiotherapy,No.6/9A, 1st cross Begur road, Hongasandra , Bengaluru - 560068
Bangalore
KARNATAKA |
7829604865
tirumalarao64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Oxford College of Physiotherapy Review Board for Ethics and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Obese |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High intensity interval training |
Structured physical activity training with adequate duration and mild to moderate intensity for a period of 4 weeks. |
| Comparator Agent |
Low intensity interval training |
Structure low intensity physical activity with adequate duration for a period of 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Overweight and Obesity
BMI>25
|
|
| ExclusionCriteria |
| Details |
Any history of cardiovascular disease, diabetes
Currently any medication
Metabolic disorder and other disorder e.g. thyroid |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| BMI |
Week 1 day 1 , Week 4 day 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| waist circumference |
Week 1 Day 1 & Week 4 Day 4 |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
25/06/2025 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Back ground : Overweight and
obesity are defined as abnormal or excessive fat accumulation that presents a
risk to health. A body mass index (BMI) over 25 is considered overweight, and
over 30 is obese. In 2019, an estimated 5 million non-communicable disease (NCD) deaths were caused by
higher-than-optimal BMI. Rates of
overweight and obesity continue to grow in adults and children. From 1990 to
2022, the percentage of children and adolescents aged 5–19 years living with
obesity increased four-fold from 2% to 8% globally, while the percentage of
adults 18 years of age and older living with obesity more than doubled from 7%
to 16%.
Obesity
is one side of the double burden of malnutrition, and today more people
are obese than underweight in every region except the South-East Asia Region.
Once considered a problem only in high-income countries, today some
middle-income countries have among the highest prevalence of overweight and
obesity worldwide.High-intensity
interval training (HIIT) refers to an exercise program that is characterized by
relatively short bursts of vigorous activity, interspersed by periods of rest
or low-intensity exercise for recovery.
Low-Intensity
Interval Training (LIIT) Low-Intensity Interval Training (LIIT) is a form of
exercise that involves alternating periods of low-intensity activity with
periods of rest or very low-intensity activity. Low intensity interval training
(LIIT) consists of periods of low impact exercise performed in intervals
combined with longer periods of rest than you might have with a HIIT (high
intensity interval training) workout. LIIT is ideal for people who are older,
new to exercise, or recovering from an injuryMethod : In this parallel group RCT study , 62 participants aged 18-25 years with obesity people from college students in Bangalore will be enrolled in a 4 weeks exercise program . Through simple random allocation , they will be randomized Main Outcome measures: The main outcome will BMI , waist circumference Data analysis: The results will be analysed using descriptive statistics , paired t test for finding the effectiveness within groups and unpaired t test for finding the effectiveness between the groups.
|