| CTRI Number |
CTRI/2017/09/009631 [Registered on: 05/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
21/06/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To Study the effects of two different Anaerobic Exercises on Physical Performances, Hormones, Anxiety Level and Sleep Quality in Soccer Players |
|
Scientific Title of Study
|
Anaerobic Training and its effects on Physical, Physiological and Psychological Parameters in Soccer Players |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Ejaz Hussain |
| Designation |
Director and Professor |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
Jamia Nagar
New Delhi
South
DELHI
110025
India |
| Phone |
|
| Fax |
|
| Email |
ehusain@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
KAMRAN ALI |
| Designation |
Research Scholar |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
Jamia Nagar
New Delhi
South
DELHI
110025
India |
| Phone |
9540686786 |
| Fax |
|
| Email |
k.alisportsphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KAMRAN ALI |
| Designation |
Research Scholar |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
Jamia Nagar
New Delhi
South
DELHI
110025
India |
| Phone |
9540686786 |
| Fax |
|
| Email |
k.alisportsphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| centre for physiotherapy and rehabilitation sciences, jamia millia islamia |
|
|
Primary Sponsor
|
| Name |
Centre for Physiotherapy and Rehabilitation Sciences |
| Address |
Jamia Millia Islamia
Jamia Nagar
New Delhi |
| Type of Sponsor |
Other [Central University] |
|
|
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 |
| Prof Ejaz Hussain |
Centre for Physiotherapy and Rehabilitation Sciences |
Centre for Physiotherapy and Rehabilitation Sciences,
Jamia Millia Islamia
Jamia Nagar
New Delhi
South
DELHI |
9899339816
ehusain@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jamia Millia Islamia |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
soccer (football) players |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
lower body anaerobic training with routine soccer training |
participants belonging to experimental group performed additional training i.e. either complex or contrast training |
| Comparator Agent |
routine soccer training |
participants belonging to control group performed only routine soccer training |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Male |
| Details |
soccer players |
|
| ExclusionCriteria |
| Details |
if any athlete has following problems/conditions
Neurological symptoms in upper/lower quadrant
History/existence of fracture/dislocation in upper/lower quadrant
History/existence of any surgical procedures(ORIF/arthroscopy etc.) on extremity/spinal joints
History/existence of contracture in upper/lower quadrant
Symptomatic low back pain
Fatty and obese athlete.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Physical performance parameters – VERTICAL JUMP TEST, AGILITY T-TEST, 20-METERS SPRINT TEST.
Physiological marker – TESTOSTERONE, CORTISOLE LEVEL
|
base line
7th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Psychological parameters – STAT AND TRAIT ANXIETY LEVEL, SLEEP QUALITY |
base line
7th week |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2017 |
| 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="2"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, single blinded,
parallel group to ascertain anaerobic training and its effects on physical,
physiological and psychological parameters in soccer players, that is being conducted at Jamia Millia Islamia. The subjects are being recruited from the university soccer team. The
primary outcome will be vertical jump test, agility t-test, 20-meters sprint test, testosterone
level, cortisol level, stat and trait anxiety level and sleep quality. |