| CTRI Number |
CTRI/2025/12/098757 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To find the effect of Exercise program on physical fitness, body composition and lipid profile in among obese class 1 population. |
|
Scientific Title of Study
|
Efficacy of four week tailored exercise program on physical fitness,anthropometric measurement and cardiovascular risk markers in obese class-I population. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Simran Sethi |
| Designation |
Post graduate Student |
| Affiliation |
SGT University |
| Address |
SGT University,School of Physiotherapy , B Block , Gurugram ,Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
8930793033 |
| Fax |
|
| Email |
simransethi9363@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Rishi |
| Designation |
Associate Professor |
| Affiliation |
SGT University |
| Address |
SGT University,School of Physiotherapy , B Block , Gurugram ,Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
8588878467 |
| Fax |
|
| Email |
Priyanka.sphy@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Simran Sethi |
| Designation |
Post graduate Student |
| Affiliation |
SGT University |
| Address |
SGT University,School of Physiotherapy , B Block , Gurugram ,Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
8930793033 |
| Fax |
|
| Email |
simransethi9363@gmail.com |
|
|
Source of Monetary or Material Support
|
| SGT University,School Of Physiotherapy,Gurugram,Haryana PIN CODE-122505 |
|
|
Primary Sponsor
|
| Name |
Simran Sethi |
| Address |
NEW D5 HSIL Hindware Colony, Bahadurgarh ,Haryana 124507 |
| 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 |
| SIMRAN SETHI |
SGT Hospital and Research institute |
SGT UNIVERSITY ,SCHOOL OF PHYSIOTHERAPY , B BLOCK , GURGAON ,HARYANA
Gurgaon
HARYANA |
8930793033
simransethi9363@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Faculty Of Physiotherapy,SGT University,Gurugram,Haryana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z682||Body mass index (BMI) 20-29, adult, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
4 Week Tailored Exercise Program |
The 4 Week Tailored Exercise Program is a program given to Experimental group where patients receives the exercise including aerobic and resistance training till 4 weeks on alternating days that is Monday ,Wednesday and Friday specifying the frequency , intensity and duration of exercise too. |
| Comparator Agent |
Conventional training |
Conventional exercise is given to control group where patients are advised to continue their regular exercise along with walking for 60 minutes. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 25–35 years diagnosed with obesity.
2. Both males and females will be included.
3. Participants with a BMI more than 25 kg per metre square.
4. Individuals leading a sedentary lifestyle.
5. Participants with no history of involvement in any structured exercise program during the past 6 months.
6. Individuals who are willing to participate in a 4-week exercise program and able to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
1.Subjects diagnosed with any orthopedic or neurological conditions.
2.Subjects diagnosed with any severe cardiovascular conditions.
3.Subjects with any metabolic disorders.
4.Any recent major surgeries.
5. Subjects with use of any medications affecting autonomic function, lipid metabolism or energy expenditure.
6.Any mental conditions affecting their body.
7.Unwillingness to continue the exercise sessions
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Physical Fitness
2.Anthropometric Measurement
3.Cardiovascular risk markers
a)Arterial Stiffness
b)Autonomic Function
c)Lipid Markers
d)Energy Cost
4.Quality of life
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
22/12/2025 |
| 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="1"
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
|
NEED OF STUDY Obesity rates were higher among women (41.88%) compared to men (38.67%), and more prevalent in urban areas (44.17%) than rural regions (36.08%). It is defined as a critical public health issue linked to increased risks of cardiovascular diseases, metabolic disorders, and impaired physical fitness. Also, because of various sedentary lifestyles which are characterized by prolonged sitting, minimal physical activity, and excessive screen time, it also has a well-established link to obesity and other related health risks. There have been several studies which highlight the impact of various exercise programs on obesity but some of them often fail to address individual differences in fitness levels, preferences, and specific health needs, leading to poor adherence and sub optimal health outcomes. So, it is a need to address the impact of tailored exercise program on physical fitness, anthropometric measurement and cardiovascular risk markers in obese class - I Population.
SIGNIFICANCE OF STUDY -Obesity Management offers a structured and time-efficient exercise intervention to help obese individuals improve their fitness levels, supports weight management by analyzing energy expenditure and energy cost. It also demonstrates the feasibility of a short-term intervention in initiating positive physiological changes. It also includes cardiovascular health improvement by reducing arterial stiffness, a key risk factor for cardiovascular disease, through improved vascular function, further enhances autonomic regulation, contributing to better heart rate control and blood pressure stability and modifies lipid profiles favorably, reducing LDL and triglycerides while increasing HDL, thereby lowering cardiovascular risk. However, there have been studies which have proved the effect of long – term exercises on obese people. This study is needed to bridge gap between generic and personalized exercise programs for obesity management. So, this study will analyze whether the effect of tailored exercise programs is quite effective on physical fitness, anthropometric measurement and cardiovascular risk markers in the obese class – I population.
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