| CTRI Number |
CTRI/2025/02/081040 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| 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
|
High Intensity Interval Training And Moderate Intensity Continuous Training Among Collegiate |
|
Scientific Title of Study
|
Effect of High Intensity Interval Training Vs Moderate Intensity Continuous Training On Cognition In Overweight College Students: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Majumi M Noohu |
| Designation |
Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room number 105, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia ,Maulana Mohammad Ali Jauhar Marg, Okhla,New Delhi
South
DELHI
110025
India |
| Phone |
9868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Majumi M Noohu |
| Designation |
Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room number 105, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia ,Maulana Mohammad Ali Jauhar Marg, Okhla,New Delhi
DELHI
110025
India |
| Phone |
9868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
somya Jha |
| Designation |
Postgraduate Student |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia ,Maulana Mohammad Ali Jauhar Marg, Okhla,New Delhi
South
DELHI
110025
India |
| Phone |
8859091201 |
| Fax |
|
| Email |
jhasomya09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia, Maulana Mohammad Ali jauhar Marg Jamia Nagar Okhla New Delhi
110025 |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Maulana Mohammad Ali Jauhar Marg Jamia Nagar Okhla New Delhi
110025 |
| Type of Sponsor |
Other [central university] |
|
|
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 Majumi M Noohu |
Centre for Physiotherapy and Rehabilitation Sciences |
Physiotherapy OPD, Room number 08 , Ground Floor , Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia ,Maulana Mohammad Ali Jauhar Marg, Okhla, New Delhi-110025
South
DELHI |
09868023378
mnoohu@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Institutional Ethical Committeee, Jamia Millia Islamia, Jamia Nagar, New Delhi-110025 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Overweight University students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
The control group will have overweight individuals and does not receive any exercise intervention |
| Intervention |
High Intensity Interval Training (HIIT) |
The HIIT group will receive exercises at RPE Borg scale 13-14 for week 1-4 and at RPE Borg Scale 14-17 for week 5-8. Exercise will be given 3 session per week for 8 weeks (total 24 sessions) under supervision. Each session will last for 20-30 mins, beginning with 5-10 mins warm-up and cool-down. |
| Intervention |
Moderate Intensity Continuous Training (MICT) |
The MICT group will receive exercises at RPE Borg scale 11-14 for week 1-8 at Continuous pace.Exercise will be given 3 session per week for 8 weeks (total 24 sessions) under supervision. Each session will last for 20-30 mins, beginning with 5-10 mins warm-up and cool-down. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
Both genders in the age group 18-24
Subjects identifies under overweight category by BMI measurement (25 to 29.9 kg/m2)
Subjects not participating in exercise training programs in the last six months and not involved in any sports
Subjects come under mild to severe category of DASS-42 scoring (depression= 10-27; anxiety= 8-19; stress= 15-33)
Subjects with MoCA score greater than or equal to 26
No prior history of any neurological disease that cause physical disability and/or limits exercises.
Subjects must have knowledge of English language undersanding. |
|
| ExclusionCriteria |
| Details |
Subjects on antidepressants medications
Subjects taking medication regarding neurological disease that directly or indirectly affecting cognition
Subjects with history of neurological condition that may alter cognition (like ADHD)
Subjects with psychiatric diagnosis at baseline or during the trial
Subjects with visual and auditory impairments
Respiratory or musculoskeletal problems that inhibit them to participate
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.EEG recordings used to analyze the frequency of brain waves that corresponds to Attention, memory, stress, anxiety and information processing.
2.Trial making Test (TMT-A and TMT-B) used to assess executive function and attentional abilities. Part A of TMT evaluates the information processing speed while Part B assess cognitive flexibility or switching. In part A the task consist in connecting numbers (from 1 to 25) with straight line as fast as possible. In Part B, participants had to alternate between letters in alphabetical order and numbers in ascending order (1-A-2-B-3-C, etc.) as fast as possible.
3. The Stroop Test assesses selective attention and inhibition.
4. Digit Span test (forward and backwards) used to measure working memory, attention and overall intelligence.
|
Baseline Assessment at 1st week before the commencement of trial
At 8th week post intervention assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
DASS-42 scale used to assess the level of Depression, Anxiety and Stress in individuals.
|
Baseline Assessment at 1st week before the commencement of trial
At 8th week post-intervention assessment |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
10/03/2025 |
| 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="6"
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
|
Background and Aim- High Intensity Interval Training (HIIT) and Moderate Intensity Continuous Training (MICT) has proven effective in improving the cognitive (Attention, memory) and psychological (Stress, Anxiety, Depression) parameters in overweight college students. Therefore the study aims to compare between these two exercise interventions and amongst them which has been more beneficial in improving attention, Memory, Stress, Anxiety and Depression .
Methodology- It will be a Prospective Randomized Control Trial including Overweight College students (Age 18-24 and BMI 25-29.9 kg/m2; both males and females). The participants will be screened by Montreal Cognitive Assessment Scale and those with score 26 or above will be included in the study. 48 overweight college students were randomly divided into 3 group. Group 1 (MICT)- will receive moderate intensity continuous training at rate of perceived exertion (RPE) Borg Scale 11-14 . Group 2 (HIIT) -will receive High Intensity Interval Training at RPE Borg scale 13-14 from week 1-4 and 15-17 for week 5-8. Group 3 (Control)- will not receive any intervention . Exercise will be done under supervision.
Result- Will be reported for all the outcome measures at Baseline and post intervention at the 8th week. Statistical analysis using SPSS software to compare the changes between the two groups and changes within the groups. |