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

Hamstring Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04050813
• Other study ID #: HSMI MSampietro Tesis
• Status: Completed
• Phase: N/A
• Start date: October 8, 2019
• Est. completion date: December 8, 2022

Study information

• Verified date: December 2021
• Source: Universidad Nacional de Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Randomized controlled intervention study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 8, 2022
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hamstring Injury
• Wounds and Injuries

Intervention

Behavioral:
• Exercises program for hamstring architecture and function
To assess the effectiveness of the inertial flywheel resistance program in the architecture and function of the hamstrings post structural hamstring injury

Locations

Country	Name	City	State
Argentina	Oulton GyMed, Rehabilitación y Gimnasio de Salud	Cordoba	Córdoba

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Nacional de Córdoba	Instituto Oulton

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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