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CTRI Number  CTRI/2024/02/062589 [Registered on: 13/02/2024] Trial Registered Prospectively
Last Modified On: 15/02/2024
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   Study to Compare effects of two techniques of core muscles strengthening on balance of male university level athletes 
Scientific Title of Study   Effect of Rotation Based Exercises vs Traditional Core Muscles Strengthening Exercises on Dynamic Balance in Male Collegiate 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  Md Shahid Raza  
Designation  Assistant Professor  
Affiliation  Jamia Millia Islamia 
Address  Room Number 106, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi

South
DELHI
110025
India 
Phone  9212156165  
Fax    
Email  mraza1@jmi.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Md Shahid Raza  
Designation  Assistant Professor  
Affiliation  Jamia Millia Islamia 
Address  Room Number-106, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi


DELHI
110025
India 
Phone  9212156165  
Fax    
Email  mraza1@jmi.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dheeraj kumar 
Designation  Post Graduate Student  
Affiliation  Jamia Millia Islamia 
Address  Room Number-106, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi

South
DELHI
110025
India 
Phone  7503906212  
Fax    
Email  dheeraj.k2704@gmail.com  
 
Source of Monetary or Material Support  
Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Jamia Nagar, Okhla, New Delhi -110025  
 
Primary Sponsor  
Name  Jamia Millia Islamia  
Address  Jamia Millia Islamia Jamia Nagar New Delhi-110025  
Type of Sponsor  Other [Central University] 
 
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 Md Shahid Raza PT   Physiotherapy Clinic, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia   Room number-08, Ground Floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana marg, Jamia nagar, okhla New Delhi
South
DELHI 
9212156165

mraza1@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  University Athletes  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Rotation based core muscles exercise  sling activation exercise protocol is used including Side-lying thoracic rotation ,Lounge and pound, Side-lying skater, Upside down turtle, Row dog, Side high plank windmill, Kneeling chop/thrust , 3 times in a week for 8 weeks. 
Comparator Agent  Traditional based core muscles exercises  Core exercise like Sit-up, Double-leg bridge, Bicycle crunch, V-up, Single-leg bridge with straight-leg raise, Swimmer, Side plank, Prone plank , 3 times in a week for 8 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  26.00 Year(s)
Gender  Male 
Details  1.University-level athletes
2.Participants should be involved more than 2 years in sports training.
3.Normal BMI 
 
ExclusionCriteria 
Details  1.Any recent trauma or injury in past six months.
2.Any neuromuscular disorder or neuromuscular deformity.
3.Participants who did not participant in at least 80 percent of training 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Y balance test
 
outcome will be assessed at baseline (T0) and after 8 weeks(T1) 
 
Secondary Outcome  
Outcome  TimePoints 
• EMG: During dynamic activity (Y balance test)
EMG: MVIC % (Max. voluntary isometric contraction).
Sports specific Endurance Plank Test (SEPT)
 
outcome will be assessed at baseline (T0) and after 8 weeks(T1) 
 
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
Modification(s)  
N/A 
Date of First Enrollment (India)   18/02/2024 
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 Yet Recruiting 
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  

Core is the group of 29 muscles that are attached to spine, pelvis and hip, stabilizes and controls them during upper and lower extremity movement. It stabilize the spine, pelvis, and kinetic chain during functional movements. The core can be characterized as a muscular box which has the abdominals in the front, paraspinals and glutei in the back, the diaphragm as the roof, and the pelvic floor and hip girdle musculature as the bottom (Akhutota & Nadler.,2004). Core muscle are composed of many muscles, mainly of local stabilizers which are small and short muscles having short lever arm to span single joint (Length dependent muscle activation pattern). It consist of Pelvic floor, Transversus abdominis, Internal Obliques, Multifidus, Diaphragm and other muscle group is Global movers: These muscles span over numerous spinal segments to produce force and function as prime movers (Force dependent activation pattern).It consist of Rectus abdominis, External obliques, Erector spinae, Quadratus lumborum, Hip muscle groups, for spinal stabilization during movement coordination of both activation pattern is required (Kibler et al., 2006).

Balance can be defined as the ability to maintain line of gravity within the Base of support (BOS) which is of two types, static and dynamic balance(Gabbard , 2008).

Athletes have excellent control over the center of gravity, be it any sport, hence, they train to achieve superior dynamic balance (Roetert,2001).Core stability results in increased control of center of mass. As the center of mass moves away from the base of support, results in increased risk for biomechanical deviations to occur in the lower extremity. An improved ability to control this movement has the potential to decrease excessive forces on the lower extremity lack of neuromuscular control of the lower limbs which has been associated with knee and ankle injuries (Kilber, et al, 2006). The core represents the biomechanical connection between the extremities and the trunk and is responsible for generating stabilization and mobility during power generation and absorption at different levels (Mcgill & S., 2010). Core strength and stabilization play an important role in efficiently transmitting the power generated during an activity from the trunk to the extremities or from the extremities to the trunk.

            Core stability, strength and endurance are the most important core abilities that ensure spine stability for force production and injury prevention. Core endurance is the most crucial component in core training, because it supports core muscles in maintaining an efficient trunk position (Faries MD, Greenwood,2007). Barati et al.(2013) indicates that core endurance is important to spinal stability during prolonged exercise.

According to a latest longitudinal study in core stability parameters, weakness in the hip external rotation was associated with incidence of knee injury (McConell.,2002). Study done by Sadeghi et al. (2013), results suggest that core stability training could be beneficial for improving balance by strengthening core muscles most often associated with lumbar spine control to improve dynamic balance.The Y-Balance Test (YBT), which is derived from the Star Excursion Balance Test (SEBT), is an low cost and commonly used objective measure to assess lower extremity dynamic balance, functional symmetry, and stability (Ruffie et al., 2019). It was designed to improve the reliability and standardize the SEBT test performance.Smith et al. (2015), found that risk for injury across various sports was associated with an increased in a reach direction asymmetry on the YBT. The performance of YBT on different surfaces produced a change in the activation of many trunk and lower extremity muscles. (Kaumantakis et al., 2005).

During dynamic movement in sports, the body tends to attempt to offer stability by increasing the muscle activation of core muscles to overcome the effects of instability, which can be measured by surface EMG in clinical setting to know the involvement of core muscles by measuring the activation level of muscles while maintain balance during movement of lower limb. Fuglevand et al., (1993), observed that muscle electrical activities are closely associated with muscle forces in isometric contractions, which signifies that the body movements would show a greater level of accumulated EMG activity which recruited more motor units from the muscles.

Some studies have demonstrated a general (global) exercise approach to be superior in reducing disability (Norris & Matthew et al., 2008) (Kaumantakis et al., 2005). Both the local and global systems are important and contributing factors to function (Kavcis, 2004). Previous studies in terms of performance have significant attention on the differentiation between the local and global muscle systems (Wirth et al., 2008).

The myofascial slings were first presented by Vleeming, and they function as anatomical keystone connections between the global muscles that provide stability and transfer of forces across multiple joints and the local stability provided by the local stabilizers, TA and segmental MF (Tayen et al. 2007). The Myofascial-Sling System is also known as core cylinder (Kibler et al., 2006), of lateral sling (internal oblique and ipsilateral gluteus Medius), posterior oblique sling (latissimus dorsi and contralateral gluteus maximus), and anterior oblique sling (external oblique and contralateral adductors).

Catania et al., 2021 ,used the clinical screening tool and Muscle ultrasound (MSUS) to compare the effects of a rotary-based exercise program that targets both the global and local muscles to a traditional exercise program on the activation of the abdominal and trunk muscles, the rotation exercises were designed to target the “sling” muscles, showing a number of significant differences between the Experimental and control groups. In the study they found thickness of the Internal oblique (IO) and External oblique (EO) muscles increased significantly more in those individuals who completed the Rotation based exercises. Both the experimental and control groups demonstrated increased thickness of Multifidus (MF) muscle, group differences not observed in MF activation,

Using exercises mentioned in the article by Catania et al., (2021), the objective of this study is to find out (1) Effect of rotation-based core muscle strengthening vs traditional core muscle strengthening on the dynamic balance of male collegiate athletes and (2) core muscle activation after rotation based and traditional core muscle exercise during dynamic balance

It is hypothesised that Rotation based exercises would significantly improve dynamic balance and muscle activation than traditional core muscle strengthening.

 

Need for the Study

·       Core strength training program is planned to improve the core strength, core stabilization, static and dynamic balance to improve performance.

·       In previous studies no work has been done on the effect of rotation-based exercises on dynamic balance.

·       In this study we want to know which type of core muscle training would be more beneficial in providing more dynamic balance & control and hence prevent chances of non-contact injuries to the athlete, and can be introduced to the athlete’s training

Research Question

·       Which type of core muscle training programme would result in more spinal stability, core muscles endurance and core muscle activation during dynamic activity.

·       Which type of core muscle training programme would result in significant improvement in dynamic balance of athlete.

Objectives

·       To find out effect of rotation-based core muscle strengthening vs traditional core muscle strengthening on the dynamic balance of male collegiate athletes.

·       To find out core muscle activation after rotation based and traditional core muscle exercise during dynamic balance.

·       To find out the effects of rotation based and traditional core muscle exercise on core endurance.

Significance of the Study

·       Previous studies have not used sling muscles specifically for long term into core training. This study helps to strengthen the previous literature on core training benefits on dynamic balance.  

·       This study compares the effect of rotation-based exercise (myofascial sling) and traditional core muscle strengthening exercise on dynamic balance.

·       This can be used as a means of rehabilitation and during training as well.

·       This study can be used to decrease risk of injury and increase performance of athletes

 

Hypothesis

Null Hypothesis: There is no significant effect of rotation-based core muscle strengthening over traditional core muscle strengthening on the dynamic balance

Alternative Hypothesis: There is a significant effect of rotation-based core muscle strengthening over traditional core muscle strengthening on the dynamic balance

Sample: Male collegiate athletes from sports complex, Jamia Millia Islamia, New Delhi, India.

Sample Size: The number of subjects (n=30) 

Duration of the study: 8 weeks

Independent Variables:

·       Rotation based exercises

·       Traditional core muscles exercises

Dependent Variables

·       Y balance test

·       EMG: During dynamic activity (Y balance test)

·       EMG: MVIC % (Max. voluntary isometric contraction).

·       Sports specific Endurance Plank Test (SEPT)

 
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