CTRI Number |
CTRI/2022/03/041057 [Registered on: 14/03/2022] Trial Registered Prospectively |
Last Modified On: |
02/12/2022 |
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
|
A clinical trial to study the effects of two exercises, mat pilates and Traditional plank in collegiate female basketball players. |
Scientific Title of Study
|
Effectiveness of Mat Pilates versus Traditional Plank on Core Muscle Endurance, Balance and Agility in Collegiate female basketball players - A Randomised control trial |
Trial Acronym |
MP and TP RCT |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Rajalakshmi I |
Designation |
Pg student |
Affiliation |
Rajiv Gandhi University of Health Sciences |
Address |
The oxford college of physiotherapy,
6/9 first cross, Begur main road Hongasandra. 4th T Block East, Pattabhirama Nagar, Jayanagar, Bengaluru, Karnataka - 560041 Bangalore KARNATAKA 560068 India |
Phone |
8438432120 |
Fax |
|
Email |
rajalakshmi16697@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Krishna M |
Designation |
lecture |
Affiliation |
Rajiv Gandhi University of Health Sciences |
Address |
The oxford college of physiotherapy,
6/9 first cross, Begur main road Hongasandra, Bangalore - 560068, karnataka. 4th T Block East, Pattabhirama Nagar, Jayanagar, Bengaluru, Karnataka - 560041 Bangalore KARNATAKA 560068 India |
Phone |
6362458697 |
Fax |
|
Email |
krishnamuralee18@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Vasanthan R |
Designation |
Principal |
Affiliation |
Rajiv Gandhi University of Health Sciences |
Address |
The oxford college of physiotherapy,
6/9 first cross, Begur main road Hongasandra. 4th T Block East, Pattabhirama Nagar, Jayanagar, Bengaluru, Karnataka - 560041 Bangalore KARNATAKA 560068 India |
Phone |
9916919685 |
Fax |
|
Email |
rvasanthan1@gmail.com |
|
Source of Monetary or Material Support
|
Pattabhiraman Sports Club |
|
Primary Sponsor
|
Name |
Rajalakshmi I |
Address |
The oxford college of physiotherapy,
6/9 first cross, Begur main road Hongasandra, Bangalore - 560068, karnataka. |
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 |
Vetrikumaran B |
Pattabhiraman Sports Club |
497, 34th cross Rd, 4th T Block East, Pattabhirama Nagar Bangalore KARNATAKA |
7708677371
vetribillu71@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
THE OXFORD COLLEGE OF PHYSIOTHERAPY REVIEW BOARD FOR ETHICS AND RESEARCH |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Core Muscle Endurance, Balance and Agility |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Mat Pilates |
core muscle strengthening exercise
1.single leg slide - ten repetitions of 3 sets on each side
2.one leg lift - ten repetitions of 3 sets on each side
3.the hundred - ten repetitions of 3 sets
These three exercise will be given for twice a week for 6 weeks and each session takes-up to 40 minutes |
Comparator Agent |
Traditional Plank |
core muscle strengthening exercise,
1. Elbow Plank - 30 sec hold and 2 repetition of 6 sets
2.Side plank - 30 sec hold and 2 repetition of 6 set on each side
3.Hand Plank - 30 sec hold and 2 repetition of 6 set,
These exercise given in twice a week for 6 weeks and 40 minutes will be taken for each session |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
25.00 Year(s) |
Gender |
Female |
Details |
collegiate female basketball players
subject had no previous experience of Mat Pilates |
|
ExclusionCriteria |
Details |
subject had injury in past 6 months
male collegiate players
low back pain players
elite/professional players
Paralympic players
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
McGill core endurance test |
At Baseline, after 6 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
Balance and Agility |
At Baseline, After 6 weeks |
|
Target Sample Size
|
Total Sample Size="46" Sample Size from India="46"
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)
|
31/03/2022 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
31/03/2022 |
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)
Modification(s)
|
Closed to Recruitment of Participants |
Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is randomized, single blinded, parallel group, multi-centre trial comparing the effect of Mat Pilates and Traditional Plank exercises given in twice a week for 6 weeks in 46 subjects of collegiate female Basketball players that will be conducted in three centers in Bangalore. The primary outcome will be assess the core muscle strength by McGill core endurance test at 1 and 6 week. The Secondary outcomes of Balance and Agility also taken by Y Balance test and T test Agilty at 1 and 6 week. |