ACL InjuryNCT06162130
Muscular Activations During Eccentric Quadriceps Exercises
A study testing Eccentric quadriceps exercises in people with ACL Injury and Sport Injury, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate muscular activations during various quadriceps exercises commonly used in clinical settings. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- ACL Injury, Sport Injury, Sports Physical Therapy
- What is being tested?
- Eccentric quadriceps exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Mar 2024
- 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a licensed athlete in one's own field, Having been engaged in sports for at least 2 years
Who cannot join
- Individuals with any musculoskeletal injury history in the lower extremities and trunk that could impede exercise within the last year, Individuals with systemic, neurological, and/or cognitive issues, Individuals experiencing pain in the lower extremities and trunk during exercises
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Muscular Activations During Eccentric Quadriceps Exercises
The aim of this study is to investigate muscular activations during various quadriceps exercises commonly used in clinical settings.
Read the detailed description
The quadriceps muscle is known to be crucial for the dynamic control of the lower extremity, and weakness in this muscle can lead to strategies that may result in injury. Therefore, acquiring optimal quadriceps muscle strength is essential not only for preventing lower extremity injuries but also for enabling individuals to fully return to activities after an injury.
Despite the existence of various eccentric quadriceps exercises in the literature, there is a lack of consensus on their comparative effectiveness. Hence, there is a requirement for research to explore the effectiveness of different eccentric quadriceps exercises. The objective of this study is to compare the muscular activation of the quadriceps muscle during four distinct eccentric quadriceps exercises using surface electromyography (sEMG) devices
- Conditions
- ACL Injury, Sport Injury, Sports Physical Therapy, Muscle Weakness
- Being tested
- Eccentric quadriceps exercises
- Keywords
- Electromyography, Exercise Theraphy, Eccentric Exercises, Quadriceps, Muscle Activity
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric quadriceps exercisesDiagnostic test
The activation of the vastus medialis, vastus lateralis, and rectus femoris muscles will be measured using surface electromyography (sEMG) during four distinct quadriceps eccentric exercises: Reverse Nordic, Pistol squat, Suspension-based Bulgarian split squat, and Bulgarian split squat. Participants will be instructed to perform three successful repetitions for each exercise. A 30-second break will be provided between each repetition, and there will be a minimum of 10 minutes of rest between each of the four exercises. Due to the belief that fatigue could impact exercise performance, the modified Borg scale will be used to ensure that fatigue does not occur before each exercise. Exercise recording will commence when scores reported using the modified Borg scale are 1 or lower.
| Study group | Role | What they receive |
|---|---|---|
| Other | Experimental | female athletes Receives: Diagnostic Test: Eccentric quadriceps exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface EMG Measurement
During data collection, the EMG Noraxon MiniDTS system (Noraxon Inc.) was used to measure the signals from the muscle. Additionally, the participants were video-recorded to prevent any potential mistakes that might have gone unnoticed during the activities.
Measured: in an average of one hour
Normalization of Surface EMG
To normalize the EMG data obtained during the exercises, MVIC will be performed for each muscle using an isokinetic dynamometer. Participants will be shown a video demonstrating the movement for MVIC, and before the test, they will be asked to warm up for 5 minutes on a treadmill at submaximal speed and then perform the movement. To ensure electromyography (EMG) normalization, participants will be asked to perform 3 repetitions, and the average of these three values will be taken.
Measured: in an average of one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Jan 2024
- Primary completion1 Feb 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif AYGUN POLAT, Ordu University
- Investigators
- Elif AYGUN POLAT, PhD, Principal investigator, Ordu UniversityNevin A. GUZEL, Prof, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162130
- Sponsor's protocol ID
- ODUSBFFTR-ELIFAYGUNPOLAT-001
- Status last verified
- Apr 2024
- First submitted
- 1 Dec 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Muscular Activations During Eccentric Quadriceps Exercises
- ClinicalTrials.gov ID
- NCT06162130
- Acronym / sponsor ID
- ODUSBFFTR-ELIFAYGUNPOLAT-001
- Conditions
- ACL Injury, Sport Injury, Sports Physical Therapy, Muscle Weakness
- Keywords
- Electromyography, Exercise Theraphy, Eccentric Exercises, Quadriceps, Muscle Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 8 Dec 2023 (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.
The aim of this study is to investigate muscular activations during various quadriceps exercises commonly used in clinical settings.
Detailed description
The quadriceps muscle is known to be crucial for the dynamic control of the lower extremity, and weakness in this muscle can lead to strategies that may result in injury. Therefore, acquiring optimal quadriceps muscle strength is essential not only for preventing lower extremity injuries but also for enabling individuals to fully return to activities after an injury.
Despite the existence of various eccentric quadriceps exercises in the literature, there is a lack of consensus on their comparative effectiveness. Hence, there is a requirement for research to explore the effectiveness of different eccentric quadriceps exercises. The objective of this study is to compare the muscular activation of the quadriceps muscle during four distinct eccentric quadriceps exercises using surface electromyography (sEMG) devices
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Other | Experimental | Diagnostic Test: Eccentric quadriceps exercisesfemale athletes |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Being a licensed athlete in one's own field, Having been engaged in sports for at least 2 years
Key exclusion criteria (1 listed)
- Individuals with any musculoskeletal injury history in the lower extremities and trunk that could impede exercise within the last year, Individuals with systemic, neurological, and/or cognitive issues, Individuals experiencing pain in the lower extremities and trunk during exercises
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 |
|---|---|---|
| Eccentric quadriceps exercisesThe activation of the vastus medialis, vastus lateralis, and rectus femoris muscles will be measured using surface electromyography (sEMG) during four distinct quadriceps eccentric exercises: Reverse Nordic, Pistol squat, Suspension-based Bulgarian split squat, and Bulgarian split squat. Participants will be instructed to perform three successful repetitions for each exercise. A 30-second break will be provided between each repetition, and there will be a minimum of 10 minutes of rest between each of the four exercises. Due to the belief that fatigue could impact exercise performance, the modified Borg scale will be used to ensure that fatigue does not occur before each exercise. Exercise recording will commence when scores reported using the modified Borg scale are 1 or lower. | Diagnostic test | Other |
Primary outcome
Surface EMG Measurement
Time frame: in an average of one hour
During data collection, the EMG Noraxon MiniDTS system (Noraxon Inc.) was used to measure the signals from the muscle. Additionally, the participants were video-recorded to prevent any potential mistakes that might have gone unnoticed during the activities.
Normalization of Surface EMG
Time frame: in an average of one hour
To normalize the EMG data obtained during the exercises, MVIC will be performed for each muscle using an isokinetic dynamometer. Participants will be shown a video demonstrating the movement for MVIC, and before the test, they will be asked to warm up for 5 minutes on a treadmill at submaximal speed and then perform the movement. To ensure electromyography (EMG) normalization, participants will be asked to perform 3 repetitions, and the average of these three values will be taken.
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 4 Apr 2024.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Elif AYGUN POLAT, PhD principal investigator
Ordu University
Nevin A. GUZEL, Prof study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric quadriceps exercises in people with ACL Injury and Sport Injury, run by Ordu University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 4 Apr 2024. 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 Turkey (Türkiye). 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?
Surface EMG Measurement (time frame: in an average of one hour). The study lists 2 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 4 Apr 2024.