| 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
|
|
|
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
|
|
|
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. |