| CTRI Number |
CTRI/2026/04/107438 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| 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
|
Effectiveness Of Movement based educational program combined with Core strengthening exercises on physical fitness, Mental health and quality of life in overweight female college students. |
|
Scientific Title of Study
|
EFFECTIVENESS OF BRAIN GYM EXERCISES COMBINED WITH CORE EXERCISES ON PHYSICAL FITNESS, MENTAL HEALTH, AND QUALITY OF LIFE
IN OVERWEIGHT FEMALE STUDENTS OF ALLIED HEALTH SCIENCES - A RANDOMIZED CONTROLLED TRIAL." |
| Trial Acronym |
IRB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRINCY MATHEW |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MEDICAL TRUST INSTITUTE OF MEDICAL SCIENCES,KOCHI |
| Address |
COLLEGE OF PHYSIOTHERAPY, MEDICAL TRUST INSTITUTE OF MEDICAL SCIENCES,KOCHI
COLLEGE OF PHYSIOTHERAPY, MEDICAL TRUST INSTITUTE OF MEDICAL SCIENCES,KOCHI
Ernakulam
KERALA
682309
India |
| Phone |
09446582509 |
| Fax |
09446582509 |
| Email |
princybruces@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.DEEPA REVI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MEDICAL TRUST INSTITUTE OF MEDICAL SCIENCES,KOCHI |
| Address |
MEDICAL TRUST INSTITUTE OF MEDICAL SCIENCES,KOCHI
MEDICAL TRUST INSTITUTE OF MEDICAL SCIENCES,KOCHI
Ernakulam
KERALA
682309
India |
| Phone |
9744585458 |
| Fax |
|
| Email |
deepa.revi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PROF. ARUN THACHIL |
| Designation |
PRINCIPAL |
| Affiliation |
MEDICAL TRUST INSTITUTE OF MEDICAL SCIENCES KOCHI |
| Address |
MEDICAL TRUST INSTITUTE OF MEDICAL SCIENCES KOCHI
MEDICAL TRUST INSTITUTE OF MEDICAL SCIENCES KOCHI
Ernakulam
KERALA
682309
India |
| Phone |
9895191924 |
| Fax |
|
| Email |
thachilarun@yahoo.in |
|
|
Source of Monetary or Material Support
|
| MEDICAL TRUST INSTITUTE OF MEDICAL SCIENCES, RIVER EAST ROAD, NEAR HOC TOWNSHIP,IRUMPANAM P.O,KOCHI, KERALA, INDIA. PIN 682309 |
|
|
Primary Sponsor
|
| Name |
PRINCY MATHEW |
| Address |
PRINCY MATHEW, ASSOCIATE PROFESSOR, MEDICAL TEUST INSTITUTE OF MEDICAL SCIENCES, KOCHI |
| Type of Sponsor |
Research institution |
|
|
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 |
| PRINCY MATHEW |
MEDICAL TRUST INSTITUTE OF MEDICAL SCIENCES |
PHYSIOTHERAPY DEPARTMENT
Ernakulam
KERALA |
09446582509
princybruces@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEDICALTRUSTHOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
OVERWEIGHT |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BRAIN GYM EXERCISES COMBINED WITH CORE EXERCISES ON PHYSICAL FITNESS, MENTAL HEALTH AND QUALITY OF LIFE IN OVERWEIGHT FEMALE STUDENTS. |
Core exercises
1st week
1. Plank
2. Side Plank (right elbow on the floor)
3. Side Plank (left elbow on the floor)
4. Opposite Arm and Leg - All fours (right leg - left arm)
5. Opposite Arm and Leg - All fours (left leg - right arm)
6. Double side Jackknife (on the right arm)
7. Double side Jackknife (on the left arm)
8. Glute Bridge
2-3rd week
1. Plank
2. Up Plank - Flutters
( each set has different legs)
3. Balance Hold
4. Plank Swimming( you should use different arm and leg in each set)
5. Russian Twist
4th week
1. Up Plank - Flutters
(each set different foot)
2. Balance Hold
3. Bent - Leg Kickbacks
(use different leg in each set)
4. Glute Bridge,Single Leg rotation
( each set different foot)
5th week
1. Up plank - Flutters(each set different foot)
2. Balance hold
3. Plank Swimming (you should use different arm and leg in each set)
4. Bent - Knee Kickbacks ( you should use different leg in each set)
5. Glute Bridge, single leg
6th week
1. Plank
2. Up plank - Flutters (each set different foot)
3. Balance hold
4. Plank Swimming (use different arm and leg in each set)
5. Bent Leg Kickbacks (use different leg in each set)
6.Glute bridge, Single leg rotation (each set different foot)
7. Russian Twists
7-8th Week
1. Up plank - Flutters (each set different foot)
2. Balance hold
(use different arm and leg in each set)
3. Bent-Leg Kickbacks
(use a different leg in each set)
4. Glute Bridge,Single Leg rotation
(each set different foot)
5. Glute bridge
6. Russian Twists
Brain Gym Exercises
1. Marching
2. Cross crawl
3. Hookups
4. Positive points
5. Brain buttons
6. Thinking cap
7. Lazy eight
8. Trace X
9. Step touch
10.Neck Circles exercise
11.The active arms
12.Cool down
|
| Comparator Agent |
Controls are the overweight female students between the age 18 to 24 years |
Controls are the overweight female students between the age 18 to 24 years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion Criteria
1. Female students of age groups 18- 24yrs
2. BMI between 23-24.9kg/m2
3. Physically inactive females
4. Subjects not involved in any other form of exercise |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
1. Subjects with known musculoskeletal ,cardiopulmonary, neurological and endocrine
problems.
2. Subjects not willing to participate
3. Subjects with any medical diseases that may impair exercise training.
4. Pregnancy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome measurements include physical fitness, Mental health and quality of life. Physical fitness includes body composition (BMI, waist hip ratio),Muscle Endurance (Mc Gill core endurance test, Muscle strength (hand dynamometer,flexibility (Sit and reach test) and cardio respiratory fitness (Six minute walk test) 2. Mental Health by Mental health battery 3. Quality of life (WHOQOL-BREF) |
Outcome measurements will be taken before the intervention and after 8 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Peak Expiratory Flow Rate |
PEFR will be checked before and after 8 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="315"
Sample Size from India="315"
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)
|
18/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/05/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
|