Quadriceps Tendon RuptureNCT04674072
The Effect of the Reverse Nordic Curl Exercise on Quadriceps Femoris Muscles Injury Rate Among Soccer Players
A study testing Reverse Nordic curl exercise and Usual warm up in people with Quadriceps Tendon Rupture and Quadriceps Strained Tendon, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial summary
The reverse Nordic curl is a body-weight exercise which mainly works the quadriceps and hip flexors. It has a large eccentric component, meaning the muscles are working whilst lengthening. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Quadriceps Tendon Rupture, Quadriceps Strained Tendon, Quadriceps Muscle Atrophy
- What is being tested?
- Reverse Nordic curl exercise and Usual warm up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 16 Jan 2021to 16 Jul 2021
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Soccer teams
- Amateur.
- Male .
- Training at least three times per week.
Who cannot join
- History of lower extremity injury requiring medical attention in the past 6 months, or systemic diseases, cardiovascular disease, neurological disorders or bone fractures or surgery in the previous year.
- Players who joined a participating team after the start of the trial will be excluded.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Umm Al Qura University
Mecca, 21955
Wesam Saleh A Al Attar, PhD, +966 54 820 6504, wsattar@uqu.edu.sa
Wesam Saleh A Al Attar, PhD
About this study
Official title: The Effect of the Reverse Nordic Curl Exercise on Quadriceps Femoris Muscles Injuries Rate Among Soccer Players: Cluster Randomized Controlled
The reverse Nordic curl is a body-weight exercise which mainly works the quadriceps and hip flexors. It has a large eccentric component, meaning the muscles are working whilst lengthening.
The purpose of this study is to investigate the effect of the reverse Nordic curl exercise on Quadriceps femoris muscles injuries among soccer players.
It hypothesized that reverse Nordic curl exercise has a beneficial effect in terms of Quadriceps femoris muscles injury prevention.
Read the detailed description
Description of intervention(s) / exposure The intervention group will be instructed to include the reverse Nordic curl exercise into their warm up 15 to 20 mins before training session (3 times per week) during one season (6 months).
Group sessions will be administered by an exercise physiologist and/ or athletic trainer and/ or soccer coaches and/ or strength and conditioning specialists and/ or physiotherapist.
Session attendance checklists will be used to assess or monitor adherence to the intervention.
The reverse Nordic curl is a body-weight exercise which mainly works the quadriceps and hip flexors. It has a large eccentric component, meaning the muscles are working whilst lengthening.
This is a very simple movement to do, but maintaining strict positioning is vital to get the full benefits. Here's how to do it:
Grab a mat on a soft floor. Kneel down, and sit on top of the feet. If trying this exercise for the first time, place the knees and feet close together, approximately hip-width apart. For more advanced, the feet and knees slightly wider, just outside the hips, to be able to lay back farther without hitting the legs.
Sit up in a tall kneeling position, push the hips forward, and lock the rib cage down. Looking to create a straight line down the front of the body, especially at the hips. This is to create a stretch at the hip flexor muscles.
Lower the shoulders towards the floor by bending at the knee, maintaining the "plank" position previously created. If hip extension is maintained, and the core adequately braced, there should be no strain on the low back, and an intense stretch felt down the front of the legs.
Continue to lean back as far as it is possible to control, then squeeze the quads to return to the starting position (this may not be very far to begin with). It is crucial to NOT let the hips drop backwards at any point during the movement. If they do, the stretch on the hip flexors will be released, defeating the point of the exercise.
Once reaching the floor and back is possible for multiple sets of 10+ repetitions, can begin loading the movement by holding a light plate, kettlebell or dumbbell.
- Being tested
- Reverse Nordic curl exercise, Usual warm up
- Keywords
- Injury Prevention Program, Reverse Nordic curl exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse Nordic curl exerciseOther
The reverse Nordic curl is a body-weight exercise which mainly works the quadriceps and hip flexors. It has a large eccentric component, meaning the muscles are working whilst lengthening.
Usual warm upOther
Usual warm up is defined as any basic exercises performed before a performance or practice to prepare the muscles for vigorous actions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will be instructed to include the reverse Nordic curl exercise into their warm up 15 to 20 mins before training session (3 times per week) during one season (6 months). Receives: Other: Reverse Nordic curl exercise |
| Control group | Active comparator | The control group will practice their usual warm up. Usual warm up is defined as any basic exercises performed before a performance or practice to prepare the muscles for vigorous actions Receives: Other: Usual warm up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of initial injuries
Injury is defined according to a consensus statement on injury definitions and data collection procedures in soccer studies; an injury will be recorded if it caused the player to be unable to completely participate in the following match or training session.
Coaches in both the experimental and control groups will be reporting injuries during training and matches by filling in forms once per week and submitting the information using the Sports Injury Tracker injury reporting form (Sports Medicine Australia).
Injury rates will be summarised as number of injuries per 1000 player-hours for both matches and training. Exposure time in hours will be calculated for each team over a 6-month period.
Measured: At the end of the intervention season (6 months).
The incidence of recurrent injuries
Recurrent injury is defined as a repeat episode of a fully recovered injury. Injury is defined according to a consensus statement on injury definitions and data collection procedures in soccer studies; an injury will be recorded if it caused the player to be unable to completely participate in the following match or training session.
Coaches in both the experimental and control groups will be reporting injuries during training and matches by filling in forms once per week and submitting the information using the Sports Injury Tracker injury reporting form (Sports Medicine Australia).
Injury rates will be summarised as number of injuries per 1000 player-hours for both matches and training. Exposure time in hours will be calculated for each team over a 6-month period.
Measured: At the end of the intervention season (6 months)
Secondary outcomes (2)
Injury severity
Defined as time loss in days (days unable to train): minor (1 to 7 days lost), moderate (8 to 21 days lost), or severe (>21 days lost). Injury severity data will be collected from Sports Injury Tracker injury reporting form.
Measured: At the end of the intervention season (6 months)
Compliance with the intervention
The rate of compliance using attendance log
Measured: At the end of the intervention season (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start16 Jan 2021 (estimated)
- Primary completion16 Jun 2021 (estimated)
- Study completion16 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quadriceps Tendon RuptureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group will be instructed to include the reverse Nordic curl exercise into their warm up 15 to 20 mins before training session (3 times per week) during one season (6 months).
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wesam Saleh A. Al Attar, PT, MSc, PhD, Umm Al-Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674072
- Sponsor's protocol ID
- HAPO-02-K-012-2020-11-480
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after de-identification will be shared.
Publications
Alonso-Fernandez D, Docampo-Blanco P, Martinez-Fernandez J. Changes in muscle architecture of biceps femoris induced by eccentric strength training with nordic hamstring exercise. Scand J Med Sci Sports. 2018 Jan;28(1):88-94. doi: 10.1111/sms.12877. Epub 2017 Apr 10.
PubMed 28314091Al Attar WSA, Soomro N, Sinclair PJ, Pappas E, Sanders RH. Effect of Injury Prevention Programs that Include the Nordic Hamstring Exercise on Hamstring Injury Rates in Soccer Players: A Systematic Review and Meta-Analysis. Sports Med. 2017 May;47(5):907-916. doi: 10.1007/s40279-016-0638-2.
PubMed 27752982
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Reverse Nordic Curl Exercise on Quadriceps Femoris Muscles Injuries Rate Among Soccer Players: Cluster Randomized Controlled
- ClinicalTrials.gov ID
- NCT04674072
- Acronym / sponsor ID
- HAPO-02-K-012-2020-11-480
- Keywords
- Injury Prevention Program, Reverse Nordic curl exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 16 Jan 2021 (estimated)
- Primary completion
- 16 Jun 2021 (estimated)
- Study completion
- 16 Jul 2021 (estimated)
- First posted
- 19 Dec 2020 (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 reverse Nordic curl is a body-weight exercise which mainly works the quadriceps and hip flexors. It has a large eccentric component, meaning the muscles are working whilst lengthening.
The purpose of this study is to investigate the effect of the reverse Nordic curl exercise on Quadriceps femoris muscles injuries among soccer players.
It hypothesized that reverse Nordic curl exercise has a beneficial effect in terms of Quadriceps femoris muscles injury prevention.
Detailed description
Description of intervention(s) / exposure The intervention group will be instructed to include the reverse Nordic curl exercise into their warm up 15 to 20 mins before training session (3 times per week) during one season (6 months).
Group sessions will be administered by an exercise physiologist and/ or athletic trainer and/ or soccer coaches and/ or strength and conditioning specialists and/ or physiotherapist.
Session attendance checklists will be used to assess or monitor adherence to the intervention.
The reverse Nordic curl is a body-weight exercise which mainly works the quadriceps and hip flexors. It has a large eccentric component, meaning the muscles are working whilst lengthening.
This is a very simple movement to do, but maintaining strict positioning is vital to get the full benefits. Here's how to do it:
Grab a mat on a soft floor. Kneel down, and sit on top of the feet. If trying this exercise for the first time, place the knees and feet close together, approximately hip-width apart. For more advanced, the feet and knees slightly wider, just outside the hips, to be able to lay back farther without hitting the legs.
Sit up in a tall kneeling position, push the hips forward, and lock the rib cage down. Looking to create a straight line down the front of the body, especially at the hips. This is to create a stretch at the hip flexor muscles.
Lower the shoulders towards the floor by bending at the knee, maintaining the "plank" position previously created. If hip extension is maintained, and the core adequately braced, there should be no strain on the low back, and an intense stretch felt down the front of the legs.
Continue to lean back as far as it is possible to control, then squeeze the quads to return to the starting position (this may not be very far to begin with). It is crucial to NOT let the hips drop backwards at any point during the movement. If they do, the stretch on the hip flexors will be released, defeating the point of the exercise.
Once reaching the floor and back is possible for multiple sets of 10+ repetitions, can begin loading the movement by holding a light plate, kettlebell or dumbbell.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention group will be instructed to include the reverse Nordic curl exercise into their warm up 15 to 20 mins before training session (3 times per week) during one season (6 months).
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Reverse Nordic curl exerciseThe intervention group will be instructed to include the reverse Nordic curl exercise into their warm up 15 to 20 mins before training session (3 times per week) during one season (6 months). |
| Control group | Active comparator | Other: Usual warm upThe control group will practice their usual warm up. Usual warm up is defined as any basic exercises performed before a performance or practice to prepare the muscles for vigorous actions |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Soccer teams
- Amateur.
- Male .
- Training at least three times per week.
Key exclusion criteria (2 listed)
- History of lower extremity injury requiring medical attention in the past 6 months, or systemic diseases, cardiovascular disease, neurological disorders or bone fractures or surgery in the previous year.
- Players who joined a participating team after the start of the trial will be excluded.
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 |
|---|---|---|
| Reverse Nordic curl exerciseThe reverse Nordic curl is a body-weight exercise which mainly works the quadriceps and hip flexors. It has a large eccentric component, meaning the muscles are working whilst lengthening. | Other | Intervention group |
| Usual warm upUsual warm up is defined as any basic exercises performed before a performance or practice to prepare the muscles for vigorous actions. | Other | Control group |
Primary outcome
Incidence of initial injuries
Time frame: At the end of the intervention season (6 months).
Injury is defined according to a consensus statement on injury definitions and data collection procedures in soccer studies; an injury will be recorded if it caused the player to be unable to completely participate in the following match or training session. Coaches in both the experimental and control groups will be reporting injuries during training and matches by filling in forms once per week and submitting the information using the Sports Injury Tracker injury reporting form (Sports Medicine Australia). Injury rates will be summarised as number of injuries per 1000 player-hours for both matches and training. Exposure time in hours will be calculated for each team over a 6-month period.
The incidence of recurrent injuries
Time frame: At the end of the intervention season (6 months)
Recurrent injury is defined as a repeat episode of a fully recovered injury. Injury is defined according to a consensus statement on injury definitions and data collection procedures in soccer studies; an injury will be recorded if it caused the player to be unable to completely participate in the following match or training session. Coaches in both the experimental and control groups will be reporting injuries during training and matches by filling in forms once per week and submitting the information using the Sports Injury Tracker injury reporting form (Sports Medicine Australia). Injury rates will be summarised as number of injuries per 1000 player-hours for both matches and training. Exposure time in hours will be calculated for each team over a 6-month period.
2 secondary outcomes
Injury severity
Time frame: At the end of the intervention season (6 months)
Compliance with the intervention
Time frame: At the end of the intervention season (6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Background: PubMed 28314091Alonso-Fernandez D, Docampo-Blanco P, Martinez-Fernandez J. Changes in muscle architecture of biceps femoris induced by eccentric strength training with nordic hamstring exercise. Scand J Med Sci Sports. 2018 Jan;28(1):88-94. doi: 10.1111/sms.12877. Epub 2017 Apr 10.
- Results publication: PubMed 27752982Al Attar WSA, Soomro N, Sinclair PJ, Pappas E, Sanders RH. Effect of Injury Prevention Programs that Include the Nordic Hamstring Exercise on Hamstring Injury Rates in Soccer Players: A Systematic Review and Meta-Analysis. Sports Med. 2017 May;47(5):907-916. doi: 10.1007/s40279-016-0638-2.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after de-identification will be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reverse Nordic curl exercise and Usual warm up in people with Quadriceps Tendon Rupture and Quadriceps Strained Tendon, run by Umm Al-Qura University at 1 site in Saudi Arabia.
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 2 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: status not confirmed, as of the sponsor's last update on 19 Dec 2020. 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 Saudi Arabia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wesam Saleh A. Al Attar, PhD (+966 54 820 6504, wsattar@uqu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of initial injuries (time frame: At the end of the intervention season (6 months).). 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?
On the ClinicalTrials.gov record for NCT04674072, which also lists 2 linked publications.
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 19 Dec 2020.