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CTRI Number  CTRI/2024/01/061685 [Registered on: 22/01/2024] Trial Registered Prospectively
Last Modified On: 18/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Fifa11+ Program Effect On Fitness Parameters And Quality Of Life In Cricketers 
Scientific Title of Study   Effect Of Fifa11+ Program On Fitness Parameters And Quality Of Life Among Cricket Players 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajat Jain  
Designation  PG SCHOLAR  
Affiliation  Amity Institute of Health Allied Sciences, Amity University Uttar Pradesh 
Address  Amity Institute of Health Allied Sciences, Amity University Noida F-1, Sector-125, NOIDA-201301, INDIA

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  8860146491  
Fax    
Email  rajatj097@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ProfDr Jasobanta Sethi 
Designation  Director  
Affiliation  Amity Institute of Health Allied Sciences, Amity University Uttar Pradesh  
Address  Room No.-18,Lower Ground Floor,F-1 Block, Department of Physiotherapy, Amity Institute of Health and Allied Science, Amity University, Sector-125, Noida-201301, Uttar Pradesh, India

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9821662045  
Fax    
Email  jsethi@amity.edu  
 
Details of Contact Person
Public Query
 
Name  ProfDr Jasobanta Sethi 
Designation  Director  
Affiliation  Amity Institute of Health Allied Sciences, Amity University Uttar Pradesh  
Address  Room No.-18,Lower Ground Floor,F-1 Block, Department of Physiotherapy, Amity Institute of Health and Allied Science, Amity University, Sector-125, Noida-201301, Uttar Pradesh, India


UTTAR PRADESH
201301
India 
Phone  9821662045  
Fax    
Email  jsethi@amity.edu  
 
Source of Monetary or Material Support  
Procure Physiotherapy and Rehabilitation Center ,Room No.-1, Ground Floor, Department of Physiotherapy, Block-C 4E/286, Janakpuri ,West Delhi, New Delhi, Delhi- 110058, India 
 
Primary Sponsor  
Name  Rajat Jain  
Address  Amity Institute of Health Allied Sciences AMITY UNIVERSITY UTTAR PRADESH, F-1, Sector-125, NOIDA-201301, INDIA 
Type of Sponsor  Other [Self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajat Jain   PRO CURE Physiotherapy & Rehabilitation Center  Room No.1, Ground Floor, Department of Physiotherapy, 286, Block-C 4E, Janakpuri ,West Delhi, New Delhi, Delhi- 110058, India
West
DELHI 
8860146491

rajatj097@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional NTCC Committee Amity Institute of Health Allied Sciences AMITY UNIVERSITY UTTAR PRADESH  Approved 
Pro cure physiotherapy and rehabilitation center  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Cricket Players 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Stretching   Athlete receive conventional static stretching protocol followed by a dynamic stretching protocol. Each protocol consisted of 10 minutes each. So, total 20minutes stretching given. The static stretching and dynamic stretching exercises were repeated 2 times on each leg. These exercises were performed for duration of 30 seconds with 10-second recovery period among each exercise. Mainly focused on quadriceps, hamstrings, gastrocnemius, soleus, gluteus, adductors, and hip flexors 
Intervention  Fifa11+ Program   Athlete receive pre-training exercises the FIFA11+ program for 20 minutes before training sessions and receive post-training exercises only running exercise for 10 minutes after training sessions, In Strength, Plyometrics and Balance exercises Level-2 (Intermediate) exercise protocol is taken. In between running exercises and level-2 strength, plyometrics and balance exercises intermittent rest should be provided. This protocol give three times per week for 4 weeks 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Cricket Players
Both male and female
Age 14-30 years
Players never participated in Fifa11+ program before  
 
ExclusionCriteria 
Details  Any recent trauma
Any neurological deficit player
Any previous fracture and surgery
Any cardiovascular pathology
Anybody who refuses to participate in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Fitness Parameters   Baseline and after 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Quality of Life   Baseline and after 4 weeks  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   26/01/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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)  

 NEED OF THE STUDY   

 There is limited studies on the effect of fifa11+ program on fitness parameters among cricketers. Flexibility, Balance, Co-ordination and Reaction time in cricketers are not investigated yet.

Hence, the investigators have intention to explore the efficacy of Fifa11+ program on rest of the fitness parameters in cricketers.  

SIGNIFICANCE  

The study will give an insight on the outcome about the effect of Fifa11+ program on fitness parameters and quality of life among Cricket players.  

This will give an insight to clinician fraternity about the exploration and efficacy of Fifa11+ program for their professional implication. This will be an easy, understandable and low cost program for athletes.

  

  AIM

To study the effect of fifa11+ program on fitness parameters and quality of life among cricket players.  

  OBJECTIVE  

To find out the effect of fifa11+ program on fitness parameters and quality of life among cricket players.   

 

HYPOTHESIS    

       

1.     NULL HYPOTHESIS- There is no significant effect of fifa11+ program on fitness parameters and quality of life among cricket players.

  

2.     ALTERNATE HYPOTHESIS- There is significant effect of fifa11+ program on fitness parameters and quality of life among cricket players.



Procedure:  

A written consent form was given to the participants ensuring participation of the athlete in this research and confidentiality of the data maintained.

The data was collected by administering V-Sit and reach test for flexibility, Y- Balance test for Balance, Agility T- test for Agility , Ruler drop test for the Reaction time, Alternate hand wall toss test for the Co-ordination and Athlete life quality scale.

Group A (Experimental group) receive pre-training exercises the FIFA11+ program for 20 minutes before training sessions and

receive post-training exercises only running exercise for 10 minutes after training sessions,

 

In Strength, Plyometrics and Balance exercises Level-2 (Intermediate) exercise protocol is taken.

In between running exercises and level-2 strength, plyometrics and balance exercises intermittent rest should be provided.

 

This protocol give three times per week for 4 weeks

 

Group B (Control group) receive conventional static stretching protocol followed by a dynamic stretching protocol. Each protocol consisted of 10 minutes each. So, total 20minutes stretching given.

The static stretching and dynamic stretching exercises were repeated 2 times on each leg. These exercises were performed for duration of 30 seconds with 10-second recovery period among each exercise. Mainly focused on quadriceps, hamstrings, gastrocnemius, soleus, gluteus, adductors, and hip flexors

 

In both groups, as a baseline intervention, subjects performed at least a 5-minute self-paced general warm-up comprising of low intensity to moderate intensity aerobic exercise including 3 minutes of forwarding jogging, 1minute of side stepping, and 1 minute of jogging backwards.

The assessment should be done at the baseline and after four weeks.

 

All the measurement of fitness parameters will be taken and computed and will be for final completion of statistical analysis



 
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