Hamstring InjuryNCT04050813
Efficacy of Flywheel Inertial Resistance Training in the Architecture and Function of the Hamstring
A study testing Exercises program for hamstring architecture and function in people with Hamstring Injury, run by Universidad Nacional de Córdoba at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Hamstring Injury
- What is being tested?
- Exercises program for hamstring architecture and function
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteArgentina
- Study dates
- 8 Oct 2019to 8 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Oulton GyMed, Rehabilitación y Gimnasio de Salud
Córdoba, Córdoba Province, 5000
About this 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
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.
Read the detailed description
Randomized controlled intervention study
- Conditions
- Hamstring Injury
- Being tested
- Exercises program for hamstring architecture and function
- Keywords
- Hamstring Injury, Flywheel Inertial Resistance, Hamstring architecture, Ultrasound, Eccentric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercises program for hamstring architecture and functionBehavioural
To assess the effectiveness of the inertial flywheel resistance program in the architecture and function of the hamstrings post structural hamstring injury
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | 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. Receives: Behavioral: Exercises program for hamstring architecture and function |
| Intervention | Experimental | 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. Receives: Behavioral: Exercises program for hamstring architecture and function |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0 and 8 week
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: week 8
Maximum Hip Flexion Active Knee Extension (MHFAKE) Test
to assess change in amplitude of movement of the hamstring in degrees with inclinometer
Measured: 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
Measured: 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
Measured: 0 and 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start8 Oct 2019
- Primary completion8 Nov 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hamstring InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Oulton
- Responsible party
- Principal investigator, Matias Sampietro, Universidad Nacional de Córdoba
- Investigators
- Vilma Campana, Phd, Study director, Departments of Biomedical Physics - University of Cordoba Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050813
- Sponsor's protocol ID
- HSMI MSampietro Tesis
- Status last verified
- Mar 2025
- First submitted
- 5 Aug 2019
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04050813
- Acronym / sponsor ID
- HSMI MSampietro Tesis
- Conditions
- Hamstring Injury
- Keywords
- Hamstring Injury, Flywheel Inertial Resistance, Hamstring architecture, Ultrasound, Eccentric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidad Nacional de CórdobaUniversity, hospital or other
- Collaborators
- Instituto Oulton
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: Exercises program for hamstring architecture and functionThe 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. |
| Intervention | Experimental | Behavioral: Exercises program for hamstring architecture and functionExperimental: 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercises program for hamstring architecture and functionTo assess the effectiveness of the inertial flywheel resistance program in the architecture and function of the hamstrings post structural hamstring injury | Behavioural | Control, Intervention |
Primary outcome
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.
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.
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.
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.
7 secondary outcomes
Change in Oslo hamstring injury screening questionnaire
Time frame: 0 and 8 week
Functional scale of the lower limb
Time frame: In the week before the 1st session of the protocol
Adverse events
Time frame: week 8
Adherence self-report questionnaire
Time frame: week 8
Maximum Hip Flexion Active Knee Extension (MHFAKE) Test
Time frame: 0 and 8 week
Single leg bridge test. Change in resistance of hamstring
Time frame: 0 and 8 week
Change in Test of a 1RM eccentric
Time frame: 0 and 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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Recruiting
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RecruitingObservational study
Neuromuscular Profiles After Anterior Cruciate Ligament Reconstruction
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vilma Campana, Phd study director
Departments of Biomedical Physics - University of Cordoba Argentina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises program for hamstring architecture and function in people with Hamstring Injury, run by Universidad Nacional de Córdoba at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the architecture and morphology of the hamstring (time frame: 0 and 8 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.