- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04050813
Efficacy of Flywheel Inertial Resistance Training in the Architecture and Function of the Hamstring
Efficacy of Flywheel Inertial Resistance Training in the Architecture and Function of the Hamstrings in Athletes With a History of Hamstring Muscle Injury
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Matias Sampietro, Phd student
- Phone Number: +549351507-0378
- Email: msampietro77@gmail.com
Study Contact Backup
- Name: Vilma Campana, Phd
- Phone Number: +5493515909500
- Email: campanav@hotmail.com
Study Locations
-
-
Córdoba
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Cordoba, Córdoba, Argentina, 5000
- Oulton GyMed, Rehabilitación y Gimnasio de Salud
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control
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. |
To assess the effectiveness of the inertial flywheel resistance program in the architecture and function of the hamstrings post structural hamstring injury
|
Experimental: Intervention
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.
|
To assess the effectiveness of the inertial flywheel resistance program in the architecture and function of the hamstrings post structural hamstring injury
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the architecture and morphology of the hamstring
Time Frame: 0 and 8 week
|
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
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Change in Maximun isometric strength
Time Frame: 0 and 8 week
|
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.
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0 and 8 week
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Change in Rate of force development
Time Frame: 0 and 8 week
|
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.
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0 and 8 week
|
Change in Maximun eccentric strength
Time Frame: 0 and 8 week
|
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
Time Frame: 0 and 8 week
|
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
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0 and 8 week
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Functional scale of the lower limb
Time Frame: In the week before the 1st session of the protocol
|
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
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In the week before the 1st session of the protocol
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Adverse events
Time Frame: week 8
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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
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week 8
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Adherence self-report questionnaire
Time Frame: week 8
|
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
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Maximum Hip Flexion Active Knee Extension (MHFAKE) Test
Time Frame: 0 and 8 week
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to assess change in amplitude of movement of the hamstring in degrees with inclinometer
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0 and 8 week
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Single leg bridge test. Change in resistance of hamstring
Time Frame: 0 and 8 week
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to assess the ability or resistance of the hamstring in repetition numbers
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0 and 8 week
|
Change in Test of a 1RM eccentric
Time Frame: 0 and 8 week
|
To assess the maximun eccentric repetition in a conventional hamstring leg curl in kg
|
0 and 8 week
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Vilma Campana, Phd, Departments of Biomedical Physics - University of Cordoba Argentina
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSMI MSampietro Tesis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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