FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/065152 [Registered on: 03/04/2024] Trial Registered Prospectively
Last Modified On: 03/04/2024
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   Enhancing Fitness and Quality of Life: The Impact of the FIFA 11+ Warm Up Program on Recreational Football Players. 
Scientific Title of Study   Effect of FIFA 11+ warm up program on fitness parameters and Athlete Quality of Life among Recreational football 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  Lavi Sharan 
Designation  PG Scholar 
Affiliation  Galgotias University 
Address  Room no 228,2nd floor, Department of physiotherpy, School of Medical and Allied Science, Galgotias University. Plot No.2 ,sector 17A, Yamuna Expressway, Gautam buddha Nagar, U.P, India.

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  08394002990  
Fax    
Email  sharan.lavi9636@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Shahiduz Zafar 
Designation  Professor 
Affiliation  Galgotias University 
Address  Room no 319,3rd floor, Department of physiotherpy, School of Medical and Allied Science, Galgotias University. Plot No.2 ,sector 17A, Yamuna Expressway, Gautam buddha Nagar, U.P, India.

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9811701345  
Fax    
Email  shahiduz.zafar@galgotiasuniversity.edu.in  
 
Details of Contact Person
Public Query  
Name  Prof Dr Shahiduz Zafar 
Designation  Professor 
Affiliation  Galgotias University 
Address  Room no 319,3rd floor, Department of physiotherpy, School of Medical and Allied Science, Galgotias University. Plot No.2 ,sector 17A, Yamuna Expressway, Gautam buddha Nagar, U.P, India.

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9811701345  
Fax    
Email  shahiduz.zafar@galgotiasuniversity.edu.in  
 
Source of Monetary or Material Support  
University Games Committee, Aligarh Muslim University. Aligarh, 202002. 
 
Primary Sponsor  
Name  Lavi Sharan 
Address  Room no. 228, 2nd floor,Department of physiotherapy, School of Medical and Allied Science, Galgotias University, plot no.2 ,Sector 17A,Yamuna Expressway, Graeter Noida , Gautam buddha Nagar, Utaar Pradesh. 
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 
Lavi Sharan  Football club  Room no.1,Ground floor ,Department of games Committe,W36F+H98,University Games Committee,AMU Campus Aligarh Muslim University, Aligarh ,Uttar Pradesh, PIN- 202002, INDIA .
Aligarh
UTTAR PRADESH 		 8394002990

sharan.lavi9636@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Departmental Ethics Committee Department of Physiotherapy Galgotias University  Approved 
University Games Committee, Aligarh Muslim University  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Recreational football players 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional warm up programe including stretching  Recreational Players 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, gastronomies, soleus, gluteus, adductors, and hip flexors. 
Intervention  FIFA 11+ warm up program  Recreational players receives total 20 mins warmup that include pre-training exercises the FIFA11+ program for 18 minutes before training sessions and receive post-training exercises only running exercise for 2 minutes after training sessions. In Strength, Plyometrics and Balance exercises Level-1 exercise protocol is taken. In between running exercises and level-1 strength, plyometrics and balance exercises intermittent rest should be provided. This protocol give three times per week for 6 weeks .  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Male 
Details  1.Recreational Football players
2.Age 18-35 years
3.Players never participated in Fifa11+ program before.
 
 
ExclusionCriteria 
Details  1. Any recent trauma
2. Any neurological deficit player
3. Any previous fracture and surgery
4. Any cardiovascular pathology
5. 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 
Agility, flexibility, Co-ordination, Balance.  Baseline and after 6 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life.  Baseline and after 6 weeks. 
 
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   Phase 3 
Date of First Enrollment (India)   15/04/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Need of study:

There are limited studies on the effect of FIFA11+ program on fitness parameters among recreational players. Speed, Agility, Strength, Balance, Endurance, Co-ordination, Power and Reaction time in recreational footballers are not investigated yet.

Hence, the investigators have intention to explore the efficacy of FIFA11+ program on rest of the fitness parameter in recreational players.

SIGNIFICANCE OF STUDY:

The study will give an insight on the outcome about the effect of FIFA 11+ program on fitness parameters and quality of life among recreational soccer players.

This will give an insight to clinician fraternity about the exploration and efficacy of FIFA 11+ program for their professional implication. This will be an easy, understandable and low cost program for recreational players.

AIM

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

 OBJECTIVES OF STUDY

  1. To check the performance levels of athletes.
  2. To ensure injury prevention.
  3. It could boost players and coaches’ program endorsements and increase warm-up adherence. This innovative study aims to ascertain the mostly unknown performance-related impacts of FIFA11+ on recreational soccer players.

Methodology

Design: Experimental study with pre-post analysis

Settings:  Athletic Ground Aligarh Muslim University, Aligarh.

Ethical Approval & Informed Consent: (English & Hindi)

Inclusion Criteria:

  1. Recreational Football players
  2. Age 18-35 years

3.        Players never participated in Fifa11+ program before.

 Exclusion Criteria:

1. Any recent trauma

2. Any neurological deficit player

3. Any previous fracture and surgery

4. Any cardiovascular pathology

5. Anybody who refuses to participate in the study.

 

GROUP ALLOCATION:

Subjects will be divided into 2 Groups, Group A, and GGroup B respectively.

Group A(Experimental group) - Players  receiving FIFA11+ program.

Group B (Control group)- Players receive Regular warm-up routine (Conventional Stretching).

 

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 Sit and reach test for flexibility, Y balance test for Balance , T test for Agility, Speed dribbling test for the Co-ordination and Athlete life quality scale.

•       Group A(Experimental group) receive pre-training exercises the FIFA11+ program for 18 minutes before training sessions and receive post-training exercises only running exercise for 2 minutes after training sessions.

In Strength, Plyometrics and Balance exercises Level-1  exercise protocol is taken.

In between running exercises and level-1 strength, plyometrics and balance exercises intermittent rest should be provided.

•       This protocol give three times per week for 6 weeks  .7

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, gastronomies, 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 six weeks.

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

Sample Size Calculation: 

t tests - Means: Difference between two independent means (two groups)

Analysis: A Priori: Compute required sample size

Total sample size = 48

INSTRUMENTS REQUIRED-

•       Marker cones

•       Measuring Tape

•       Stopwatch

•       Weighing machine

•       Football.

 Study Protocol / Intervention:

1. FIFA 11+ warm up programe

2. Conventional warmup

Results

Mention the relevant statistical Tests to be used for the study:

Hypothetically we could conclude the result.

NULL HYPOTHESIS- There maybe or may not be significant effect of FIFA 11+ program on fitness parameters and quality of life among recreation football players.

ALTERNATE HYPOTHESIS- There is significant effect of FIFA 11+ program on fitness parameters and quality of life among recreation football players.

 


 
Close