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CTRI Number  CTRI/2023/11/060128 [Registered on: 22/11/2023] Trial Registered Prospectively
Last Modified On: 21/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Crossover Trial 
Public Title of Study   full body vibration effects on sports performance when given at two different times 
Scientific Title of Study   To Compare Chronotype Dependent Effects of Whole-Body Vibration on Neuromuscular Performance in Male Collegiate Athletes: A Randomized Cross-over Study 
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 Moazzam Hussain Khan PT 
Designation  Assistant Professor 
Affiliation  Jamia Millia Islamia 
Address  Centre for Physiotherapy and Rehabilitation Sciences, Room No. 112, Jamia Nagar Jamia Millia Islamia, New Delhi

South
DELHI
110025
India 
Phone  9990307150  
Fax    
Email  mkhan47@jmi.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Moazzam Hussain Khan PT 
Designation  Assistant Professor 
Affiliation  Jamia Millia Islamia 
Address  Centre for Physiotherapy and Rehabilitation Sciences, Room No. 112, Jamia Nagar Jamia Millia Islamia, New Delhi

South
DELHI
110025
India 
Phone  9990307150  
Fax    
Email  mkhan47@jmi.ac.in  
 
Details of Contact Person
Public Query
 
Name  Sameer Ahmed 
Designation  Post Graduate Student 
Affiliation  Jamia Millia Islamia 
Address  R-6/2 street no 20 Brahampuri

North East
DELHI
110053
India 
Phone  7982379259  
Fax    
Email  sameermalik784080@gmail.com  
 
Source of Monetary or Material Support  
Centre for Physiotherapy and rehablitation sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Jamia Nagar, Okhla, New Delhi, 110025 
 
Primary Sponsor  
Name  Centre for Physiotherapy and rehabilitation sciences 
Address  Jamia Millia islamia, Centre for Physiotherapy and rehabilitation sciences, Jamia Nagar, New Delhi-110025 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Moazzam Hussain Khan  Physiotherapy clinic, Centre of Physiotherapy and Rehabilitation Sciences  Physiotherapy clinic room no 02 Ground floor, Centre of Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Marg, Jamia Nagar, Okhla, New Delhi 110025
South
DELHI 
9990307150

mkhan47@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy subjects  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Evening Chronotype group  5-minute whole body vibration training consisting of two 30-second squatting exercise sets and two 30-second single-leg squatting exercise sets with 30-second rest intervals (Total duration 10 minutes) Evening type in the Evening as well as in the Morning based on randomization 
Comparator Agent  Morning Chronotype group  5-minute whole body vibration training consisting of two 30-second squatting exercise sets and two 30-second single-leg squatting exercise sets with 30-second rest intervals (Total duration 10 minutes) Morning type in the morning as well as in the evening based on randomization 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  26.00 Year(s)
Gender  Male 
Details  1. Male collegiate athletes 2. Morning and Evening Chronotype type participant 3. Age 18-26 years 4. BMI Normal (18.5 - 24.9 kg/m2) 5. Non-smokers 6. An individual who understands written and verbal 7. English language and consent to participate 8. Playing for the last 6 months 8. No difficulty in functional activities like squatting, prolonged sitting, ascending and descending stairs or sloped surfaces, squatting, running, kneeling, and hopping/jumping.
 
 
ExclusionCriteria 
Details  1. Chronotype of intermediate variety 2. Subjects with unstable angina and myocardial infarction in the previous month 3. Resting HR: more than 120mmhg 4. SPO2: Room air Spo2 at rest ≤ 93% 5. History of any surgery or injury of the lower extremities in the past 1 year 6. Subjects with any history/diagnosed case of medical/systemic, musculoskeletal, neurological, or psychological condition that can affect the outcome of the study 7. Any regular medication which can affect the result of the study 8. Any recent trauma
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Self-reported revised version Morningness-eveningness questionnaire (MEQ-REV-SR)
Muscle Activity: EMG %MVIC of Vastus lateralis and Vastus medialis
Test for agility (T-test)
20-m single sprint
Countermovement jump height
Y- Balance test
 
The outcome will be assessed at baseline(T0), after whole body vibration training in the morning or evening(T2), After whole body vibration training in morning or evening after 48hour washout period(T3) 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   04/12/2023 
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  

INTRODUCTION

Chronotype is an individual’s inclination towards morningness or eveningness that is typically assessed via self-assessment questionnaires (Terman et al., 2001;Horne & Ostberg, 1976). Chronotype is divided into three categories: morning type, evening type, and neither type; it reflects the time of day when numerous psychophysiological variables peak (Jacopo Antonino Vitale & Weydahl, 2017).
 

NEED OF THE STUDY

·       This research will add to our understanding of how whole-body vibration affects neuromuscular performance such as Strength, Power, Speed, Agility, and Balance.

·       This research will also help determine when whole body vibration is most useful and which types of athletes (morning vs. evening) gain the most from WBV. As a result, it is vital to know the effect of WBV on NMP in athletes of diverse chronotypes.

·       To the best of my knowledge, no study has incorporated the acute effects of WBV at two separate times based on chronotype. The study’s novelty is the effectiveness of WBV on neuromuscular performance based on different chronotypes and at two separate times.

 RESEARCH QUESTION

Is there any change in the NMP of a collegiate male athlete depending on his Chronotype, after single-bout of whole-body vibration applied at two separate times of the day?

 OBJECTIVES OF THE STUDY

·       To find the acute effects of WBV on neuromuscular performance in male collegiate athletes.

·       To implement the WBV as a treatment for enhancing neuromuscular performance utilizing %Maximum voluntary isometric contraction(%MVIC), Countermovement jump height, 20m single sprint, T-test, and Y-balance test.

·       To find out when WBV is most useful (morning vs evening time), as well as which types of athletes (morning vs. evening type) gain the most from WBV.

HYPOTHESIS OF THE STUDY

Null Hypothesis

There will be no statistically significant variations in Neuromuscular performance amongst male collegiate athletes of different chronotypes who use WBV at two distinct time periods.

 Experimental hypothesis

There will be statistically significant variations in Neuromuscular performance amongst male collegiate athletes of different chronotypes who use WBV at two distinct time periods.

SIGNIFICANCE OF THE STUDY

This research will add to our understanding of whether chronotype can affect the training and thus the performance of an athlete. It will also help us to determine how whole-body vibration affects neuromuscular performance such as Strength, Speed, Power, Agility, and balance. This research will also help determine when whole body vibration is most useful and which types of athletes (morning vs. evening) gain the most from WBV. As a result, it is vital to know the effect of WBV on NMP in athletes of diverse chronotypes.

PROTOCOL FOR DATA COLLECTION:

Subjects will be recruited from different department of Jamia Millia Islamia, M.A.K Pataudi sports complex and the surrounding community based on inclusion and exclusion criteria, and they will be informed about the study. The goal of the study and any potential dangers will be addressed to the individual. They will be provided with informed consent after being informed of their rights as study subjects. A self-administered questionnaire will be used to choose subjects. A self-report version of revised Morningness-Eveningness Questionnaire (MEQ-REV-SR) will be used to divide people into three chronotypes: morning, intermediate, and evening MEQ (Terman M et al., 2001;Horne & Ostberg, 1976). The intermediate collegiate player will be excluded from the study. Then the subjects will be separated into two groups: Morning group and evening group on the basis of said questionnaire. Subjects will receive WBV training either in the morning or in the evening randomly using the chit method. Following 48 hours of wash-out period the subject will be requested to the alternate session than what he has already done. All identifying information on the permission form, as well as demographic data, will be kept strictly confidential.

 PROCEDURE:

·       The subjects will be selected on the basis of inclusion and exclusion criteria. They will be asked to fill out the self-reported revised version of Morningness-Eveningness personality questionnaire(MEQ-REV-SR) to assess the chronotype (Terman M et al., 2001;Horne & Ostberg, 1976). Subjects will also be screened to rule out any disease with the help of physical activity readiness questionnaire.

·       Subjects will be given 1-day rest from the game before the WBV training and testing to avoid the training effects. Subjects will be instructed not to perform any form of exercise and not to consume alcohol or coffee 24hr prior to the session, as it will affect the training and testing. A familiarization session will be done for both groups.

·       Before WBV training, both groups will complete a general warmup activity that includes 5 minutes of jogging and active stretching of the major lower limb muscles (2 repetitions of gluteus, quadriceps, hamstring, and calf stretching for 30 seconds).

·       Following a one-minute rest, three trials of baseline measurement of the Y-balance test, %MVIC, CMJ height, 20-m sprint time, and T-test time will be performed.

·       After 5 minutes, subjects will be requested to pick up a chit depending on which they shall be subjected to receive WBV, in the morning or evening.

·       During WBV training, subjects will be required to stand on a WBV platform and be subjected to a vertical sinusoidal mechanical WBV. For 5 minutes, a 30 Hz vibration frequency and a peak-to-peak amplitude 2.5mm of WBV dosage will be delivered. Subjects will receive a single bout of WBV training consisting of two 30-second squatting exercise sets and two 30-second single-leg squatting exercise sets with 30-second rest intervals (Munshi et al., 2022).

·       After giving WBV training, three trials of post-test measurement of the Y-balance, %MVIC through EMG, CMJ height, 20m sprint time, and T-test will be performed, and the best of the three will be recorded.

·       Subjects will be asked to take a 48-hour break to lessen the effects of fatigue on test performance. After 48 hours, the subjects will be swapped to receive intervention.

Then, again, after WBV training, three trials of post-test measurement of Y-balance test, %MVIC CMJ height, 20m sprint time, and T-test will be performed, and the best of the three will be recorded.

Variables

Independent variable

·       Whole body vibration

       Dependent variable

·       % MVIC (Maximum voluntary isometric contraction)

·       Countermovement jump height

·       20m sprint time

·       T-test

·       Y balance test

 
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