| CTRI Number |
CTRI/2024/02/062369 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To observe the effect of total resistance exercise and theratube exercise on quadricep femoris strength and speed in football players
|
|
Scientific Title of Study
|
Comparing the effect of total resistance exercise and theratube Exercise on quadricep femoris strength and speed in football players: A Randomised clinical trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jain Rishi Hemsingh |
| Designation |
PG Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Centre, room no. 39, Sagar floor, KLE Dr. Prabhakar Kore Hospital and MRC, Belgaum
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9624910000 |
| Fax |
|
| Email |
rj73073@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basavaraj Motimath |
| Designation |
Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Centre, room no. 39, Sagar floor, KLE Dr. Prabhakar Kore Hospital and MRC, Belgaum
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9886100461 |
| Fax |
|
| Email |
bsmotimath@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Basavaraj Motimath |
| Designation |
Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Centre, room no. 39, Sagar floor, KLE Dr. Prabhakar Kore Hospital and MRC, Belgaum
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9886100461 |
| Fax |
|
| Email |
bsmotimath@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Advanced Physiotherapy Centre,Room no 39 Sagar Floor KLE DR Prabhakar Kore Hospital and MRC Belgaum Karnataka India |
|
|
Primary Sponsor
|
| Name |
Jain Rishi Hemsingh |
| Address |
Advanced Physiotherapy Centre, room no. 39, Sagar floor, KLE Dr. Prabhakar Kore Hospital and MRC, Belgaum
|
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 |
| Jain Rishi Hemsingh |
KLE Dr. Prabhakar Kore Hospital |
Advanced Physiotherapy Centre, room no. 39, Sagar floor, KLE Hospital and MRC, Belgaum
Belgaum
KARNATAKA |
9624910000
rj73073@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee KLEU Institute of Physiotherapy Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Football Players |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Theratube Exercises |
This group will be undergoing their conventional daily training along with Theratube exercises for 3 sessions per week for 3 weeks. Week one :SESSION one : Knee Extension
(with yellow theratube) 10 repetitions x 1 set SESSION 2: Knee Extension
(with yellow theratube)
10 repetitions X 1 set SESSION 3:Knee Extension
(with yellow theratube)
10 repetitions X 1 set Week two :SESSION 4: Knee Extension
(with red theratube) 10 repetitions x 2 sets SESSION 5: Knee Extension
(with red theratube)
10 repetitions X 2 sets SESSION 6:Knee Extension
(with red theratube)
10 repetitions X 2 sets Week three :SESSION 7: Knee Extension
(with red theratube) 10 repetitions x 3 sets SESSION 8: Knee Extension
(with red theratube)
10 repetitions X 3sets SESSION 9:Knee Extension
(with red theratube)
10 repetitions X 3sets |
| Intervention |
Total Resistance Exercise |
Total Resistance Training
The intervention group will undergo their daily training along with Total Resistance training with Total Resistance Bands for 3 sessions per week for 3 weeks. Week one: SESSION 1: Suspended knee extension 10 repetition x 1 set single leg suspended SESSION 2: Suspended knee extension 10 repetition x 1 set single leg suspended SESSION 3: Suspended knee extension 10 repetition x 1 set single leg suspended Week two: SESSION 4: Suspended knee extension 10 repetition x 2 set both leg suspended SESSION 5: Suspended knee extension 10 repetition x 2 set both leg suspended Week three: SESSION 7: Suspended knee extension 10 repetition x 3 set both leg suspended SESSION 8: Suspended knee extension 10 repetition x 3 set both leg suspended SESSION 9: Suspended knee extension 10 repetition x 3 set both leg suspended |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Football players who are willing to participate and they should have 1 year of playing experience. |
|
| ExclusionCriteria |
| Details |
Football players who have any lower limb injury or fracture in past 6 months and players who are undergoing any lower limb rehabilitation. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dynamometer(Hand Held dynamometer) and Radar Gun (pocket radar ball coach gun) |
Baseline and post intervention(3 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
10/03/2024 |
| Date of Study Completion (India) |
05/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Participants will be divided into 2 groups. The participants baseline data will be taken with help of dynamometer for quadriceps strength and radar gun for kicking speed will be taken : The intervention group will undergo Total Resistance Exercise . On field with help or Total resistance band.The instructions are to do suspended knee extension with single leg suspended and later on progresses to both legs suspended . The intervention will be given for 9 sessions, 3 sessions per week. The other group will undergo Theratube exercises knee extension with help of yellow theratube later progressed to red theratube for 9 sessions 3 sessions per week The data will be collected at baseline and at the end of 2 weeks of training. Statistical Analysis will be done to determine the results of the study. |