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CTRI Number  CTRI/2024/02/062278 [Registered on: 05/02/2024] Trial Registered Prospectively
Last Modified On: 13/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The hamstring key: Can this exercise routine be your injury-prevention weapon?  
Scientific Title of Study   Effectiveness of multifactorial hamstring injury risk reduction programme on Hamstring muscle architecture in recreational athletes: A pragmatic 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  Pranay Maru 
Designation  Student 
Affiliation  Manipal College of Health Professions 
Address  Department of Exercise and Sport Sciences, Manipal College of Health Professions, Manipal, Udupi - 576104, Karnataka, India.

Udupi
KARNATAKA
576104
India 
Phone  8104336379  
Fax    
Email  maru.amit@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  MrPrabu Raja G  
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Exercise and Sport Sciences, Manipal College of Health Professions, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  8876591333  
Fax    
Email  prabu.raja@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  MrPrabu Raja G  
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Exercise and Sport Sciences, Manipal College of Health Professions, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  8876591333  
Fax    
Email  prabu.raja@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Department of Radiodiagnosis and Imaging. 
Manipal College of Health Professions, Department of Exercise and Sport Science. 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 
Prabu Raja G  Kasturba Medical College  Manipal College of Health Professions, Department of Exercise and sport sciences, Marena Sports Complex, Manipal, Udupi- 576104
Udupi
KARNATAKA 
8867591333

prabu.raja@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee of kasturba medical college and kasturba hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Recreational Athletes 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group   In the control group: the participants will not be provided with the interventional plan (multifactorial and individualised risk reduction protocol) and they will be allowed to continue with their type of training or no training if the participant does not train.  
Intervention  Multifactorial and individualised risk reduction protocol  This intervention is for 6 weeks long with 3 sessions each week. The training session will last for around 30 - 40 minutes and the exercises which will be performed will be 3 sets of 8 repetitions each. Energy drinks will be provided post session.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  English speaking participants
Recreational athletes - individuals who use the sport as their personal in fitness and are participating in community based or university based leagues. 
 
ExclusionCriteria 
Details  Participants with a history of hamstring strain injury in the past 6 months and participants with any lower extremity injury. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Muscle architecture of the biceps femoris long head - includes fascicle length, pennation angle and muscle thickness  Pre and Post 
 
Secondary Outcome  
Outcome  TimePoints 
Sprint mechanical profile - includes time, velocity, position, horizontal acceleration , horizontal net force, relative horizontal net force, horizontal power, net horizontal power ,net horizontal power, relative horizontal power, vertical force and ratio of force.  Pre and Post 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   10/02/2024 
Date of Study Completion (India) 02/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 02/05/2024 
Estimated Duration of Trial   Years="0"
Months="6"
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  

The importance of hamstring injuries in sports, especially football, where they make up a significant portion of injuries, is discussed in the literature. Extrinsic (modifiable) and intrinsic (modifiable and non-modifiable) variables can both have an impact on these injuries. Player position and surroundings are examples of extrinsic elements, whereas internal factors include range of motion, sleep patterns, diet, strength, age, gender, and injury history.

Research by Johan Lahti suggests six key elements for an individual and multifactorial protocol targeted at lowering hamstring injuries and enhancing sprint performance in order to address these hazards thoroughly. These elements include posterior chain strength, manual treatment, lumbo-pelvic control, range of motion training, high-speed sprint exposure, and coordinated training. But there are drawbacks to earlier studies, including insufficient data on exercise intensity and reliance on questionable ultrasound measures for muscle architecture.

The major goal of the study is to assess the impact of a multifactorial, Individualised programme on the architecture of the muscles, with particular attention paid to pennation angle, muscle thickness, and fascicle length. Muscle thickness, angle of pennation, cross-sectional area, and fascicle length are all aspects of muscle architecture. Muscle thickness is measured as the perpendicular distance between superficial and deep aponeuroses, angle of pennation is the average angle of fascicles with respect to the aponeuroses, and fascicle length is the span from one end to the other.

The association between fascicle length and hamstring injury risk in professional football players is highlighted by research by Timmins et al. They discovered that shorter fascicles had a greater risk of damage using B-Mode ultrasound. In addition, the incidence of hamstring strain injury fell by 73.9% for every 0.5 cm increase in fascicle length. Later research on the effects of eccentric strength training on muscle architecture has shown a growth in fascicle length.

The research also examines the mechanical profile of a sprint, concentrating on sprint timings and net horizontal force. The 2020 study by Timmins et al. examined how strength training using Nordic hamstring exercises and hip-dominant flywheels affected muscle architecture and the mechanical characteristics of sprints. The study made use of timing gates placed at various distances and obtained the outputs of the net horizontal force velocity using an Excel spreadsheet. Results showed that the FLY participant group produced much more horizontal power and improved sprint timings, especially in the 5m and 10m distances.

The research emphasizes the complexity of hamstring injuries and the demand for a thorough strategy to reduce risks are highlighted in its conclusion. The suggested multifaceted, individualized approach covers range of motion training, posterior chain strength, lumbo-pelvic control, and high-speed sprint exposure. However, prior research relied on estimates to quantify muscle architecture and lacked exact information on exercise intensity. This study’s main goal is to determine how this treatment affects the muscle architecture and mechanical characteristics of sprint. 
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