Efficacy of Flywheel Inertial Resistance Training in the Architecture and Function of the Hamstring

Study Overview
=================
Brief Summary
-----------------
Investigate the efficacy of the inercial Flywheel training protocol in modifying the architecture and function of the hamstrings in patients with a history of structural muscle injury vs conventional training. The researchers hypothesize that inercial Flywheel training protocol will be a useful strategy in the modification of the architecture and function of the hamstring in patients with a history of indirect structural muscle injury and decrease the recurrence.

Detailed Description
-----------------
Randomized controlled intervention study

Official Title
-----------------
Efficacy of Flywheel Inertial Resistance Training in the Architecture and Function of the Hamstrings in Athletes With a History of Hamstring Muscle Injury

Conditions
-----------------
Hamstring Injury

Intervention / Treatment
-----------------
* Behavioral: Exercises program for hamstring architecture and function


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with history of structural muscle injuries type 3 of the Munich Consensus classification for muscular injuries, confirmed by imaging diagnosis no more than 2 years ago. The patient must have performed conventional medical and physiotherapy treatment Have Returned to their usual sporting activity With good mental health. Exclusion Criteria: Suffer from a systemic pathology that could alter the healing biology of the muscle. Present other lesions in the muscular group of extrinsic characteristic or not encompassed within type 3 structural lesions such as, for example, proximal or distal insertion tendinopathy, use of semitendinous as anterior cruciate ligament graft. Prior knee or hip surgery. Having been infiltrated with platelet rich plasma in the posterior thigth region in the previus 3 months before startin the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>The program is performed 2 times per week using resistance equipment in a physiotherapy clinic. Each session consists of on 2-legged loaded exercises for hamstring, quadriceps, gluteus maximun and core. The patients complete 3 or 4 sets in each exercise with a 2- to 3-minute rest between sets and a 5-minute rest period between the 4 exercises. The number of repetitions decreases, and load gradually increases, every week. The repetitions and loads are as follows: 3 set of 12-repetition maximum (12RM), in week 1 and 2; 3 set of 10 RM, in week 3 and 4; 4 set of 10RM, in weeks 5 and 6; and 4 set of 8RM, in weeks 7 to 8. | Behavioral: Exercises program for hamstring architecture and function<br>* To assess the effectiveness of the inertial flywheel resistance program in the architecture and function of the hamstrings post structural hamstring injury<br>|
| Experimental: Intervention<br>Experimental: Inertial flywheel resistance training The program is performed 2 times per week using resistance equipment in a physiotherapy clinical. Inertial flywheel resistance is a type of strength training; which is based on the increasing demands on eccentric action (breaking) after a concentric action (acceleration), due to the inertial load caused during the return movement. The patients complete 16 repetition maximum (RM) with moment inertia 0.05 m² from week 1-2, 24 repetition maximum (RM) with moment inertia = 0.10 m² from week 3 to 4. 32 repetition maximum (RM) with moment inertia = 0.10 m² from week 5 to 6 and 32 repetition maximum (RM) with moment inertia = 0.13 m² in a flywheel hamstring curl devise. | Behavioral: Exercises program for hamstring architecture and function<br>* To assess the effectiveness of the inertial flywheel resistance program in the architecture and function of the hamstrings post structural hamstring injury<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the architecture and morphology of the hamstring | To assess change in architecture and morphology of the hamstring at 8 week. It will be performed by a medical specialist in diagnostic imaging with a A GE Voluson 730 Expert model ultrasound machine , with 6-12 MHz linear transducer. Panoramic images of the long portion of the biceps femoris and semitendinosus will be taken from its proximal insertion, In each muscle, muscle thickness, fascicle length, penetration angle and physiological cross-sectional area will be evaluated. | 0 and 8 week | 
| Change in Maximun isometric strength | To assess change in maximum isometric strength of hamstring in Newton (N). It will be measured in 3 repetitions with a hand dynamometer at two knee flexion angles. | 0 and 8 week | 
| Change in Rate of force development | To assess change in rate of force development of hamstring in N/seg at 8 week. it will be measured in 3 repetitions with a hand dynamometer at two knee flexion angles. | 0 and 8 week | 
| Change in Maximun eccentric strength | To assess the maximum eccentric strength of hamstring in Newton (N) from basiline. It will be measured in 3 repetitions with a hand held dynamometer. | 0 and 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Oslo hamstring injury screening questionnaire | Self-administered questionnaire. The hamstring injury detection test will be carried out to assess the previous injury, symptoms, function and quality of life of these players with the Oslo hamstring injury screening questionnaire questionnaire.This tool is divided in 23 items within 5 categories: symptoms, discomfort, pain depending on daily activity, sports and quality of life for injuries in right or left hamstrings | 0 and 8 week | 
| Functional scale of the lower limb | Self-reported patient-specific outcome measure assess functional change, primarily in patients presenting with musculoskeletal disorders. Patients are asked to identify up to 3 important activities they are unable to perform or are having difficulty with as a result of their problem. In addition to identifying the activities, patients are asked to rate, on an 11-point scale, the current level of difficulty associated with each activity. Following the intervention, patients are asked again to rate the activities previously identified. the lower limb will be used in its version validated in Argentina | In the week before the 1st session of the protocol | 
| Adverse events | To capture all adverse events and side effects that occurred after exercises protocol. Patients reported any changes or any symptoms. If a question was answered yes, we asked for further comments To capture all adverse events and side effects that occurred after exercises protocol. Patients reported any changes or any symptoms. If a question was answered yes, we asked for further comments | week 8 | 
| Adherence self-report questionnaire | Patients were asked to choose one of six descriptions (from level 1 = perfect adherence to level 6 = nonadherence) to express exercise treatment at the end of the twelve weeks study period. | week 8 | 
| Maximum Hip Flexion Active Knee Extension (MHFAKE) Test | to assess change in amplitude of movement of the hamstring in degrees with inclinometer | 0 and 8 week | 
| Single leg bridge test. Change in resistance of hamstring | to assess the ability or resistance of the hamstring in repetition numbers | 0 and 8 week | 
| Change in Test of a 1RM eccentric | To assess the maximun eccentric repetition in a conventional hamstring leg curl in kg | 0 and 8 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hamstring Injury, Flywheel Inertial Resistance, Hamstring architecture, Ultrasound, Eccentric