| CTRI Number |
CTRI/2024/11/077450 [Registered on: 28/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| 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
|
Effect of Physiotherapy intervention on University-level athletes |
|
Scientific Title of Study
|
Effect Of Whole Body Vibration Training As An Adjunct To Conventional Training On Physical Performance Factors In University-level Athletes: A Randomized Controlled 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 |
Dr Suraj Kumar |
| Designation |
Professor |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia |
| Address |
Room No 203
Second Floor
Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
Mohammad Ali Marg Jamia Nagar
New Delhi 110025
India
South
DELHI
110025
India |
| Phone |
7830337168 |
| Fax |
|
| Email |
skumar2@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suraj Kumar |
| Designation |
Professor |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia |
| Address |
Room No 203
Second Floor
Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
Mohammad Ali Marg Jamia Nagar
New Delhi 110025
India
South
DELHI
110025
India |
| Phone |
7830337168 |
| Fax |
|
| Email |
skumar2@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Shahbaz Alam |
| Designation |
Student |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia |
| Address |
Room No 116
First Floor
Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
Mohammad Ali Marg Jamia Nagar
New Delhi 110025
India
South
DELHI
110025
India |
| Phone |
9650505167 |
| Fax |
|
| Email |
alamshahbaz445@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia
Mohammad Ali Marg
Jamia Nagar
New Delhi 110025
India |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
Mohammad Ali Marg Jamia Nagar
New Delhi 110025
India |
| 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 |
| Dr Suraj Kumar |
Jamia Millia Islamia |
Room no 08
Physiotherapy OPD
Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia Mohammad Ali Marg Jamia Nagar
New Delhi 110025
India
South
DELHI |
7830337168
skumar2@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Jamia Millia Islamia New Delhi 110025 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy University-level athletes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Conventional Physiotherapy.
The exercises of conventional physiotherapy will be conducted for 35 mins per session, 3 times per week, for a total of 4 weeks (total 12 sessions). Exercise program will consist of warm-up for 6 mins, main exercises for 25 mins (it will consist of balance training and core stability exercises), and cool-down exercises for 4 mins. Balance training will consist of exercises on firm surface in week 1 and wobble board exercises from week 2-4. Core stability exercises will consist of 8 different types of exercises. |
| Intervention |
Whole Body Vibration training |
Whole Body Vibration (WBV) training combined with conventional Physiotherapy.
WBV training will be given 3 times per week, for a total of 4 weeks (total 12 sessions). Duration of vibration training will be 7 minutes. Frequency of WBV will be 25 Hz in week 1-2, and 30 Hz in week 3-4. Amplitude of WBV will be 4 mm.
The exercises of conventional physiotherapy will be conducted for 35 mins per session, 3 times per week, for a total of 4 weeks (total 12 sessions). Exercise program will consist of warm-up for 6 mins, main exercises for 25 mins (it will consist of balance training and core stability exercises), and cool-down exercises for 4 mins.
Balance training will consist of exercises on firm surface in week 1 and wobble board exercises from week 2-4.
Core stability exercises will consist of 8 different types of exercises.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
University-level athletes involved in any sports
Age 18 to 30 years
Both genders
Working knowledge of English language
Normal BMI: 18.5-24.9 kg/m2
Participants must have at least 1 year of playing experience
Participants should be involved in sport-specific training on at least 2 days per week |
|
| ExclusionCriteria |
| Details |
Any cardiovascular respiratory abdominal urinary neurological or musculoskeletal disease
Prior training on WBV in last 3 months
Use of medications that could affect the musculoskeletal system
Any musculoskeletal surgery or musculoskeletal disorders in past 1 year
Any ocular disease affecting retina |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Static Balance
Dynamic Balance
Proprioception |
At day 0 and at week 4. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reaction Time
Isometric Strength
Power |
At day 0 and at week 4. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
07/12/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
All the subjects will be informed about the nature, purpose, and possible risks involved in the study and an informed written consent will be taken from them prior to participation. All the subjects will be selected based on the inclusion criteria. Subjects will be familiarized with all the testing procedures and training prior to the commencement of the study and then an anthropometric evaluation and testing of outcome parameters will be done. The outcome parameters include static balance, dynamic balance, proprioception, reaction time, isometric strength, and power. Then, the subjects will be randomly allocated into one of the two groups as group A and group B in a 1:1 allocation ratio by a computer generated randomization method. Group A will receive whole body vibration combined with balance and core training and group B will receive balance and core training alone. Both the groups will then be analyzed after 4 weeks of training on outcome parameters. |