Back to resultsEfficacy of Flywheel Inertial Resistance Training in the Architecture and Function of the Hamstring
Primary Purpose
Hamstring Injury
Status
Unknown status
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Exercises program for hamstring architecture and function
Sponsored by
About this trial
This is an interventional treatment trial for Hamstring Injury focused on measuring Hamstring Injury, Flywheel Inertial Resistance, Hamstring architecture, Ultrasound, Eccentric
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
Sites / Locations
- Oulton GyMed, Rehabilitación y Gimnasio de SaludRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control
Intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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
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
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
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.
Maximum Hip Flexion Active Knee Extension (MHFAKE) Test
to assess change in amplitude of movement of the hamstring in degrees with inclinometer
Single leg bridge test. Change in resistance of hamstring
to assess the ability or resistance of the hamstring in repetition numbers
Change in Test of a 1RM eccentric
To assess the maximun eccentric repetition in a conventional hamstring leg curl in kg
Full Information
NCT ID
NCT04050813
First Posted
August 5, 2019
Last Updated
September 27, 2021
Sponsor
Universidad Nacional de Córdoba
Collaborators
Instituto Oulton
1. Study Identification
Unique Protocol Identification Number
NCT04050813
Brief Title
Efficacy of Flywheel Inertial Resistance Training in the Architecture and Function of the Hamstring
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 8, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Nacional de Córdoba
Collaborators
Instituto Oulton
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hamstring Injury
Keywords
Hamstring Injury, Flywheel Inertial Resistance, Hamstring architecture, Ultrasound, Eccentric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercises program for hamstring architecture and function
Intervention Description
To assess the effectiveness of the inertial flywheel resistance program in the architecture and function of the hamstrings post structural hamstring injury
Primary Outcome Measure Information:
Title
Change in the architecture and morphology of the hamstring
Description
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.
Time Frame
0 and 8 week
Title
Change in Maximun isometric strength
Description
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.
Time Frame
0 and 8 week
Title
Change in Rate of force development
Description
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.
Time Frame
0 and 8 week
Title
Change in Maximun eccentric strength
Description
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.
Time Frame
0 and 8 week
Secondary Outcome Measure Information:
Title
Change in Oslo hamstring injury screening questionnaire
Description
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
Time Frame
0 and 8 week
Title
Functional scale of the lower limb
Description
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
Time Frame
In the week before the 1st session of the protocol
Title
Adverse events
Description
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
Time Frame
week 8
Title
Adherence self-report questionnaire
Description
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.
Time Frame
week 8
Title
Maximum Hip Flexion Active Knee Extension (MHFAKE) Test
Description
to assess change in amplitude of movement of the hamstring in degrees with inclinometer
Time Frame
0 and 8 week
Title
Single leg bridge test. Change in resistance of hamstring
Description
to assess the ability or resistance of the hamstring in repetition numbers
Time Frame
0 and 8 week
Title
Change in Test of a 1RM eccentric
Description
To assess the maximun eccentric repetition in a conventional hamstring leg curl in kg
Time Frame
0 and 8 week
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matias Sampietro, Phd student
Phone
+549351507-0378
Email
msampietro77@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vilma Campana, Phd
Phone
+5493515909500
Email
campanav@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilma Campana, Phd
Organizational Affiliation
Departments of Biomedical Physics - University of Cordoba Argentina
Official's Role
Study Director
Facility Information:
Facility Name
Oulton GyMed, Rehabilitación y Gimnasio de Salud
City
Cordoba
State/Province
Córdoba
ZIP/Postal Code
5000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matias Sampietro, Phd student
Phone
+5493515070378
Email
msampietro77@gmail.com
First Name & Middle Initial & Last Name & Degree
Lucas Pereyra Thiem
Phone
+5493517619692
Email
lucas_pereira217@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Flywheel Inertial Resistance Training in the Architecture and Function of the Hamstring
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