Groin InjuriesNCT04673903
The Effect of the Copenhagen Adduction Exercise on Groin Injuries Rate Among Soccer Players.
A study testing Copenhagen adduction exercise and Usual warm up in people with Groin Injuries, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial summary
The effect of the Copenhagen Adduction Exercise on groin injuries rate among soccer players The Copenhagen adduction exercise is a body-weight exercise which mainly works the groin and hip Adductors. 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
- Groin Injuries
- What is being tested?
- Copenhagen adduction 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.
About this study
Official title: The Effect of the Copenhagen Adduction Exercise on Groin Injuries Rate Among Soccer Players. A Cluster Randomized Controlled Trial.
The effect of the Copenhagen Adduction Exercise on groin injuries rate among soccer players The Copenhagen adduction exercise is a body-weight exercise which mainly works the groin and hip Adductors. 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 Copenhagen adduction exercise on groin injuries among soccer players.
It hypothesized that Copenhagen adduction exercise has a beneficial effect in terms of groin injury prevention.
Read the detailed description
Study type Interventional Description of intervention(s) / exposure The intervention group will be instructed to include the Copenhagen adduction exercise into their warm up 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 Copenhagen adduction exercise is a body-weight exercise which mainly works the groin and hip adductor. It has a large eccentric component, meaning the muscles are working whilst lengthening.
The Copenhagen Adduction exercise is a simple isolated eccentric partner exercise and doesn't require special equipment and can be performed as a warm up activity on the pitch.
The Copenhagen Adduction exercise requires a partner who will hold the player's upper leg in an extended position nearly at the hip level of the partner, with one hand supporting the knee and the other upholding the ankle. Meanwhile, the player will lie on one side and support the body with the forearm on the ground and the top arm being placed along the body. Then, the player will elevate the trunk from the floor and raise the lower leg in a straight line. The player will repeat this for 3 seconds until the feet touch each other. This will be followed by slightly lowering the body just to the ground for 3 seconds until it touches the level of the foot.
It must be performed on both limbs. It is crucial to note that the most accurate performance of the exercise must avoid trunk bending. In terms of the training form, the frequency is three-two sessions per week while the repetition varies according to the different levels of the players ranging from 3-12 times in one-two sets.
Prevention Comparator / control treatment 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.
- Conditions
- Groin Injuries
- Being tested
- Copenhagen adduction exercise, Usual warm up
- Keywords
- Copenhagen Adduction Exercise, Groin injuries, Soccer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copenhagen adduction exerciseOther
The Copenhagen Adduction exercise is a simple isolated eccentric partner exercise and doesn't require special equipment and can be performed as a warm up activity on the pitch.
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 Copenhagen adduction exercise into their warm up before training session (3 times per week) during one season (6 months).
The Copenhagen adduction exercise is a body-weight exercise which mainly works the groin and hip adductor. It has a large eccentric component, meaning the muscles are working whilst lengthening. Receives: Other: Copenhagen adduction 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.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.
Data will be collected from Sports Injury Tracker injury reporting form. 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.
Data will be collected from Sports Injury Tracker injury reporting form.
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 time of any injury occurring throughout intervention soccer 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 posted17 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 (5)Papers the sponsor has linked to this study.
- Other trials for Groin InjuriesStudies 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 Copenhagen adduction exercise into their warm up before training session (3 times per week) during one season (6 months).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.
- 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
- NCT04673903
- Sponsor's protocol ID
- HAPO-02-K-012-2020-11-481
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 17 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
Ishoi L, Sorensen CN, Kaae NM, Jorgensen LB, Holmich P, Serner A. Large eccentric strength increase using the Copenhagen Adduction exercise in football: A randomized controlled trial. Scand J Med Sci Sports. 2016 Nov;26(11):1334-1342. doi: 10.1111/sms.12585. Epub 2015 Nov 21.
PubMed 26589483Haroy J, Clarsen B, Wiger EG, Oyen MG, Serner A, Thorborg K, Holmich P, Andersen TE, Bahr R. The Adductor Strengthening Programme prevents groin problems among male football players: a cluster-randomised controlled trial. Br J Sports Med. 2019 Feb;53(3):150-157. doi: 10.1136/bjsports-2017-098937. Epub 2018 Jun 10.
PubMed 29891614Holmich P, Uhrskou P, Ulnits L, Kanstrup IL, Nielsen MB, Bjerg AM, Krogsgaard K. Effectiveness of active physical training as treatment for long-standing adductor-related groin pain in athletes: randomised trial. Lancet. 1999 Feb 6;353(9151):439-43. doi: 10.1016/S0140-6736(98)03340-6.
PubMed 9989713Holmich P. Groin injuries in athletes--development of clinical entities, treatment, and prevention. Dan Med J. 2015 Dec;62(12):B5184.
PubMed 26621401Haroy J, Thorborg K, Serner A, Bjorkheim A, Rolstad LE, Holmich P, Bahr R, Andersen TE. Including the Copenhagen Adduction Exercise in the FIFA 11+ Provides Missing Eccentric Hip Adduction Strength Effect in Male Soccer Players: A Randomized Controlled Trial. Am J Sports Med. 2017 Nov;45(13):3052-3059. doi: 10.1177/0363546517720194. Epub 2017 Aug 14.
PubMed 28806100
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Copenhagen Adduction Exercise on Groin Injuries Rate Among Soccer Players. A Cluster Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04673903
- Acronym / sponsor ID
- HAPO-02-K-012-2020-11-481
- Conditions
- Groin Injuries
- Keywords
- Copenhagen Adduction Exercise, Groin injuries, Soccer
- 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
- 17 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 effect of the Copenhagen Adduction Exercise on groin injuries rate among soccer players The Copenhagen adduction exercise is a body-weight exercise which mainly works the groin and hip Adductors. 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 Copenhagen adduction exercise on groin injuries among soccer players.
It hypothesized that Copenhagen adduction exercise has a beneficial effect in terms of groin injury prevention.
Detailed description
Study type Interventional Description of intervention(s) / exposure The intervention group will be instructed to include the Copenhagen adduction exercise into their warm up 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 Copenhagen adduction exercise is a body-weight exercise which mainly works the groin and hip adductor. It has a large eccentric component, meaning the muscles are working whilst lengthening.
The Copenhagen Adduction exercise is a simple isolated eccentric partner exercise and doesn't require special equipment and can be performed as a warm up activity on the pitch.
The Copenhagen Adduction exercise requires a partner who will hold the player's upper leg in an extended position nearly at the hip level of the partner, with one hand supporting the knee and the other upholding the ankle. Meanwhile, the player will lie on one side and support the body with the forearm on the ground and the top arm being placed along the body. Then, the player will elevate the trunk from the floor and raise the lower leg in a straight line. The player will repeat this for 3 seconds until the feet touch each other. This will be followed by slightly lowering the body just to the ground for 3 seconds until it touches the level of the foot.
It must be performed on both limbs. It is crucial to note that the most accurate performance of the exercise must avoid trunk bending. In terms of the training form, the frequency is three-two sessions per week while the repetition varies according to the different levels of the players ranging from 3-12 times in one-two sets.
Prevention Comparator / control treatment 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.
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 Copenhagen adduction exercise into their warm up before training session (3 times per week) during one season (6 months).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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Copenhagen adduction exerciseThe intervention group will be instructed to include the Copenhagen adduction exercise into their warm up before training session (3 times per week) during one season (6 months). The Copenhagen adduction exercise is a body-weight exercise which mainly works the groin and hip adductor. It has a large eccentric component, meaning the muscles are working whilst lengthening. |
| 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 (1 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 |
|---|---|---|
| Copenhagen adduction exerciseThe Copenhagen Adduction exercise is a simple isolated eccentric partner exercise and doesn't require special equipment and can be performed as a warm up activity on the pitch. | 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.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. Data will be collected from Sports Injury Tracker injury reporting form. 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. Data will be collected from Sports Injury Tracker injury reporting form.
2 secondary outcomes
Injury severity
Time frame: At time of any injury occurring throughout intervention soccer 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 17 Dec 2020.
- Background: PubMed 26589483Ishoi L, Sorensen CN, Kaae NM, Jorgensen LB, Holmich P, Serner A. Large eccentric strength increase using the Copenhagen Adduction exercise in football: A randomized controlled trial. Scand J Med Sci Sports. 2016 Nov;26(11):1334-1342. doi: 10.1111/sms.12585. Epub 2015 Nov 21.
- Background: PubMed 29891614Haroy J, Clarsen B, Wiger EG, Oyen MG, Serner A, Thorborg K, Holmich P, Andersen TE, Bahr R. The Adductor Strengthening Programme prevents groin problems among male football players: a cluster-randomised controlled trial. Br J Sports Med. 2019 Feb;53(3):150-157. doi: 10.1136/bjsports-2017-098937. Epub 2018 Jun 10.
- Background: PubMed 9989713Holmich P, Uhrskou P, Ulnits L, Kanstrup IL, Nielsen MB, Bjerg AM, Krogsgaard K. Effectiveness of active physical training as treatment for long-standing adductor-related groin pain in athletes: randomised trial. Lancet. 1999 Feb 6;353(9151):439-43. doi: 10.1016/S0140-6736(98)03340-6.
- Background: PubMed 26621401Holmich P. Groin injuries in athletes--development of clinical entities, treatment, and prevention. Dan Med J. 2015 Dec;62(12):B5184.
- Background: PubMed 28806100Haroy J, Thorborg K, Serner A, Bjorkheim A, Rolstad LE, Holmich P, Bahr R, Andersen TE. Including the Copenhagen Adduction Exercise in the FIFA 11+ Provides Missing Eccentric Hip Adduction Strength Effect in Male Soccer Players: A Randomized Controlled Trial. Am J Sports Med. 2017 Nov;45(13):3052-3059. doi: 10.1177/0363546517720194. Epub 2017 Aug 14.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Copenhagen adduction exercise and Usual warm up in people with Groin Injuries, 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 1 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 17 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?
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?
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 NCT04673903, which also lists 5 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 17 Dec 2020.