| CTRI Number |
CTRI/2023/12/060664 [Registered on: 22/12/2023] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| 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
|
Comparison of different high intensity training on physical and physiological parameters in collegiate level athletes |
|
Scientific Title of Study
|
Comparison of different high intensity training on physical and physiological parameters in collegiate level athletes |
| 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 Adila Parveen |
| Designation |
Assistant Professor |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (Central university) |
| Address |
111, 1st floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (Central university), New Delhi, India
New Delhi
DELHI
110025
India |
| Phone |
918587868142 |
| Fax |
|
| Email |
aparveen1@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Adila Parveen |
| Designation |
Assistant Professor |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (Central university) |
| Address |
111, 1st floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (Central university), New Delhi, India
New Delhi
DELHI
110025
India |
| Phone |
918587868142 |
| Fax |
|
| Email |
aparveen1@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Faraz Ahmed |
| Designation |
MPT student |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (Central university) |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (Central university), New Delhi, India
New Delhi
DELHI
110025
India |
| Phone |
9718927507 |
| Fax |
|
| Email |
faraz331@live.com |
|
|
Source of Monetary or Material Support
|
| Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Jamia Millia Islamia (Central university), New Delhi, India |
| 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 |
| Dr Adila Parveen |
Jamia Millia Islamia |
Centre for Physiotherapy and rehab. sciences
Jamia Millia Islamia
Jamia Nagar
New Delhi
DELHI |
918587868142
aparveen1@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Collegiate level athletes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Functional based high intensity training
|
functional HIIT incorporating multiple exercises, all executing with their own body weight (3-4 sets; 8x
20 s, 10 s rest; set rest: 5 min) |
| Comparator Agent |
Running based high intensity training |
Participants will be performing a running HIIT (3-4 sets; 8x 20 s, 10 s rest; set rest: 5 min) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Aged between 18 to 25 years of age.
Both male and female
Participants who are college level athletes
VO2 max greater than 35ml/kg/min
More than 2 years of experience of the sport.
|
|
| ExclusionCriteria |
| Details |
• If yes to any question on PAR-Questionnaire.
• Any lower limb injury in the past 3 months. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Muscle activity
Maximum aerobic capacity
Running economy
Muscle endurance
Rate of perceived exertion
Anaerobic speed endurance
|
Pre reading
Post readings after 4 weeks training |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Muscle activity
Running economy
Muscle endurance
Rate of perceived exertion
|
Pre reading
Pist after 4weekas |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 |
|
Date of First Enrollment (India)
|
31/12/2023 |
| 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="6"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Collegiate athletes will be recruited from Nawab Mansoor Ali Khan Pataudi Sports Complex at Jamia
Millia Islamia University according to the inclusion and exclusion criteria. To reduce the chances of
injury players will be screened for preparedness for the training protocols as both are high intensity
trainings. Subjects will be explained the purpose, methodology and possible risk of the study. They will
be given, and made to sign an informed consent form explaining their rights as research subjects.
Subjects will be divided into three groups – functional based high intensity group (n= 15) and running
based high intensity group (n= 15) and a control group(n=15). All identifying information and the
consent from and demographic history will be kept confidential. Group A will receive functional based
high intensity training, Group B will receive running based High intensity training and Group C will
continue their usual routine training. 4 weeks of training sessions will be held. Data will be collected
on the first day and the end of 4 weeks. After getting the consent form signed by them pre data of muscle
activity, VO2 max, Anaerobic speed endurance, muscular endurance, RPE will be taken. After the
training sessions post reading will be taken to compare the effects of the two training protocols. |