| CTRI Number |
CTRI/2023/02/049421 [Registered on: 02/02/2023] Trial Registered Prospectively |
| Last Modified On: |
31/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Clinical trial to study the effect of two exercise program aerobic exercise and cognitive behavioral therapy in student with obesity |
|
Scientific Title of Study
|
Effectiveness of aerobic exercise and cognitive behavioral therapy on BMI and Hip Waist Ratio in obese students of Parul University - A Comparative Study |
| Trial Acronym |
To compare Physical exercise and talk, thinking therapy among students with obesity. |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mansi Vora |
| Designation |
PG student |
| Affiliation |
Parul Institute Of Physiotherapy |
| Address |
Parul University Of Physiotherapy
Waghodia Road, Limda, Vadodara
Waghodia Road, Limda, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9769552709 |
| Fax |
|
| Email |
mansivora19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nensi Gandhi |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute Of Physiotherapy |
| Address |
Room number:232,Parul sevashram Hospital,Parul University Of Physiotherapy
Waghodiya Road, Limda, Vadodara
Waghodiya Road, Limdi, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9913577382 |
| Fax |
|
| Email |
nensimodi70@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mansi Vora |
| Designation |
PG Student |
| Affiliation |
Parul Institute Of Physiotherapy |
| Address |
Parul University Of Physiotherapy
Waghodiya Road, Limdi, Vadodara
Waghodiya Road, Limdi, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9769552709 |
| Fax |
|
| Email |
mansivora19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Parul sevashram hospital |
| Address |
Parul University Of Physiotherapy
Waghodia Road, Limda, Vadodara |
| Type of Sponsor |
Private 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 |
| Mansi Vora |
Parul Institute Of Physiotherapy |
Parul University Of Physiotherapy
Waghodia Road, Limda, Vadodara
Vadodara
GUJARAT |
9769552709
mansivora19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Commitee For Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Obese students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic Exercise |
Aerobic exercise training, or conditioning, is augmentation of the energy utilization of the muscle by means of an exercise program.It is given for 8 weeks. |
| Comparator Agent |
Cognitive Behavioral Therapy |
Cognitive Behavioral Therapy approaches are aimed at modifying dysfunctional emotions, behaviors, and thoughts.It is given for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-25 years
BMI less than or equal to 25
Those who are willing to participate
|
|
| ExclusionCriteria |
| Details |
Subjects already participate in yoga, gym activities and physical fitness training.
Any severe orthopeadic conditions like fracture.
Any comorbidities like hypertension, diabetes. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
BMI
|
8 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Waist Hip Ratio |
8 Weeks |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/02/2023 |
| 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="2"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim: To study the Effectiveness of Aerobic exercise and Cognitive Behavioral Therapy on BMI and Hip Waist Ratio in Obese students of Parul University - A comparative study Objectives: To evaluate the effect of aerobic exercise exercise on BMI. To evaluate the effect of Cognitive Behavioral Therapy on BMI. To evaluate the effect of aerobic exercise on Waist to Hip Ratio. To evaluate the effect of Cognitive Behavioral Therapy on Waist to Hip Ratio. |