| 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
|
|
|
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
|
|
|
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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