| CTRI Number |
CTRI/2024/11/076783 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of body fat distribution on physical fitness in young adults |
|
Scientific Title of Study
|
Association of fat distribution with endurance, cardiovascular fitness and body composition in young adults |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vindhya Gupta |
| Designation |
Postgraduate Student |
| Affiliation |
Amar Jyoti Institute of Physiotherapy, Delhi |
| Address |
Physiotherapy department, Exercise therapy laboratory 1,
Room no 1, 2nd floor, Amar Jyoti Institute of Physiotherapy, Vikas Marg, Karkardooma, Anand Vihar, Delhi
East
DELHI
110092
India |
| Phone |
8529176912 |
| Fax |
|
| Email |
vin21599@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tarun Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
Physiotherapy department, Exercise therapy laboratory 1, Room no 1, 2nd floor, Amar Jyoti Institute of Physiotherapy, Vikas Marg, Karkardooma, Anand Vihar, Delhi
East
DELHI
110092
India |
| Phone |
8745802112 |
| Fax |
|
| Email |
physiotarun29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tarun Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
Physiotherapy department, Exercise therapy laboratory 1, Room no 1, 2nd floor, Amar Jyoti Institute of Physiotherapy, Vikas Marg, Karkardooma, Anand Vihar, Delhi
East
DELHI
110092
India |
| Phone |
8745802112 |
| Fax |
|
| Email |
physiotarun29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amar Jyoti Institute of Physiotherapy, Vikas Marg, Karkardooma, Delhi, India, 110092 |
|
|
Primary Sponsor
|
| Name |
Vindhya Gupta |
| Address |
Physiotherapy department, Exercise therapy laboratory 1, Room no 1, 2nd floor, Amar Jyoti Institute of Physiotherapy, Vikas Marg, Karkardooma, Anand Vihar, Delhi, India, 110092 |
| 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 |
| Dr Vindhya Gupta |
Amar Jyoti Institute of Physiotherapy, Delhi |
Physiotherapy department, Exercise therapy laboratory 1,
Room No 1, 2nd floor, Vikas Marg, Karkardooma, Anand Vihar, Delhi, 110092
East
DELHI |
8529176912
vin21599@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amar Jyoti Institutional Review Board- Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Overweight and obese being screened |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Participants aged between 18 to 40 years
Participants with BMI 23 or above
Both males and females
Participants who are willing to participate in the study voluntarily by signing informed consent form.
|
|
| ExclusionCriteria |
| Details |
History of congenital or acquired structural abnormalities
History of any recent major trauma or accident (in the past 6 months)
History of any recent surgery involving the spine, abdomen or lower extremity
History of any congenital or acquired respiratory disorder
History of any acquired and congenital cardiovascular disorders
History of psychological disorders
History of any neurological conditions
Pregnant females |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Trunk Flexor and Extensor Endurance test for endurance 2. Cooper’s 12 min walk/run test for cardiovascular fitness
3. Bioelectrical Impedance for body composition
4. Waist to Hip Ratio for body type |
1. Baseline
2. Baseline
3. Baseline
4. Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
Final Enrollment numbers achieved (Total)= "134"
Final Enrollment numbers achieved (India)="134" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2024 |
| Date of Study Completion (India) |
24/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study explores the association between fat distribution patterns and key physical fitness components endurance, cardiovascular fitness and body composition in overweight and obese young adults aged 18-40. The correlational study will be conducted on participants recruited via convenience sampling from the Therapeutic laboratory-1, 2nd floor, Amar Jyoti Institute of Physiotherapy. Fat distribution will be assessed using the waist-to-hip ratio (WHR) to classify participants into apple-shaped and pear-shaped categories. By conducting tests such as the Cooper’s 12-minute run/walk for cardiovascular fitness, trunk flexor and extensor endurance tests and bioelectrical impedance for body composition, this study seeks to identify how different fat distributions (apple vs. pear-shaped) influence these fitness outcomes. The findings will offer valuable insights for developing targeted fitness programs and interventions to mitigate the health risks associated with obesity in young adults. |