| CTRI Number |
CTRI/2025/05/087307 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Short term effects of elastic band based supervised and unsupervised exercise on body strength and fitness |
|
Scientific Title of Study
|
impact on short term physical activity program on fitness, cognitive functioning and well-being among students pursuing doctoral degree students at a university: a pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
venkat pydi |
| Designation |
post graduate student |
| Affiliation |
Manipal college of higher education |
| Address |
department of exercise and sports science, Manipal college of higher education, MAHE, Manipal
department of exercise and sports science, Manipal college of higher education, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8985703370 |
| Fax |
|
| Email |
venkat.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Baskaran Chandrasekaran |
| Designation |
Assistant Professor |
| Affiliation |
Manipal college of higher education |
| Address |
Department of exercise and sports science, Manipal college of higher education, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7639820751 |
| Fax |
|
| Email |
baskaran.c@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
venkat pydi |
| Designation |
post graduate student |
| Affiliation |
Manipal college of higher education |
| Address |
department of exercise and sports science, Manipal college of higher education, MAHE, Manipal
department of exercise and sports science, Manipal college of higher education, MAHE, Manipal
KARNATAKA
576104
India |
| Phone |
8985703370 |
| Fax |
|
| Email |
venkat.mchpmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
venkat pydi |
| Address |
department of exercise and sports science, Manipal college of higher education, MAHE, Manipal
department of exercise and sports science, Manipal college of higher education, MAHE, Manipal |
| 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 |
| venkat pydi |
Manipal College of Health Professions |
Department of exercise and sports science, Manipal college of higher education, MAHE, Manipal
department of exercise and sports science, Manipal college of higher education, MAHE, Manipal
Udupi
KARNATAKA |
8985703370
venkat.mchpmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and hospital instutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
young adults enrolled in doctoral degree |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
resistance exercise training |
6 weeks of an intervention study for 3days a week
the main targeting muscles are chest, triceps, back, shoulders, legs, glutes, core |
| Comparator Agent |
unsupervised group |
6 weeks of study for 3 days. the main targeting muscles are chest, triceps, back, shoulder, legs, glutes, and core. for them giving pamphlet to the participants and tell them to maintain a logbook to track the training session |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
they should be low to moderate baseline physical activity
there should be no recent injuries or medical conditions for the participants. |
|
| ExclusionCriteria |
| Details |
pre-existing health condition
pregnancy
major illness/injury (acute or chronic)
cardiovascular disease
medical/orthopedic conditions that would limit physical activity |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
flexibility
cardiovascular fitness
strength |
0th week& 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
flexibility- sit and reach test
cardiovascular fitness- Chester step test
upper body strength- push ups
lower body strength- wall squats
cognitive functioning- Eriksen flanker test
wellbeing- student wellbeing questionaries |
0th week & 6th week |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 2 |
|
Date of First Enrollment (India)
|
24/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 shows the improvement in muscle endurance, cardiovascular fitness, and flexibility with resistance training, and cognitive functioning by the Eriksen Flanker test, and student subjective well-being questionnaires will be given |