NCT05589623

Brief Summary

Groin injuries are among the three most common and time-consuming injuries in soccer, accounting for 19% of all injuries, with 0.1-2.1 injuries per 1000 hours of play. The Copenhagen Adduction Exercise (CAE) has been showing promising results in improving Eccentric Hip Adduction Strength (EHADS), leading to reducing the risk of groin pain and injury. This clinical trial aims to evaluate the effects of CAE on adductors strength, hip joint range of motion (ROM), and Patient-reported outcome measures among athletes with groin pain or injury. The main question it aims to answer is: Does the CAE improve EHAD strength, hip joint ROM, and patient-reported outcome measures among soccer players with groin pain or injury? Researchers will assess the participants' pre and post-intervention to determine the effects of CAE on adductors strength, hip joint ROM, and Patient-reported outcome measures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2023

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2023

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

October 14, 2022

Last Update Submit

July 5, 2023

Conditions

Keywords

Copenhagen Adduction ExerciseEccentric Hip Adduction StrengthGroin injury, groin painSoccer. athletes

Outcome Measures

Primary Outcomes (2)

  • Change in eccentric hip adduction strength from baseline

    A portable hand-held dynamometer (microFET2) will be used for the test. A blind physiotherapist will perform pre and post-testing. Each patient's affected leg will be tested. The examiner will position the hand-held dynamometer 5 cm proximal to the most prominent part of the medial malleolus. Eccentric hip adduction strength will be measured in a break test with the patient in a side-lying position, with the leg being tested in a straight position. The participant will perform a 3-5 second isometric maximum voluntary contraction against the dynamometer before the physiotherapist performs a contraction break to determine the eccentric hip adduction strength. The patient will complete one practice trial before three maximal tests are performed, with the best result recorded. The standardized command by the examiner will be "go ahead-push-push-push-push-push." Leg length will be used to calculate torque and be adjusted to body mass (Nm/kg).

    At the end of the intervention sessions (8 weeks)

  • Change in hip joint range of motion measures from baseline

    Hip joint ROM can be reliably assessed using a goniometer. The assessor will perform an internal and external hip joint range of motion testing with the subject supine and the hip and knee in 90 degrees of flexion pre-and post-testing will be performed. An assistant will be used to ensure that the hip and knee remain in their proper positions. The affected leg will be rotated to the maximum range of passive internal rotation (IR), external rotation (ER), and abduction movement (ABD). The standard goniometer will be used to make the measurements, and the testing period will be approximately ten minutes.

    At the end of the intervention sessions (8 weeks)

Secondary Outcomes (1)

  • Change in the Copenhagen Hip and Groin Outcome Score

    At the end of the intervention sessions (8 weeks)

Study Arms (2)

Copenhagen adduction exercise

EXPERIMENTAL

The CAE is a body-weight exercise that mainly works the groin and hip adductors. It has a significant eccentric component, meaning the muscles work while lengthening. The CAE is a simple isolated eccentric exercise that does not require special equipment. Due to the heaviness and the high dynamic demands of CAE, a modified progressive Copenhagen adduction (MPCA) program has been created. The MPCA exercise was adapted from the original CAE to lessen the risk of delayed onset muscle soreness (DOMS) and facilitate high participant compliance. An experienced physical therapist will include the MPCA in the usual rehabilitation program for eight weeks, twice weekly. Sessions will last between 30 and 120 minutes.

Other: Copenhagen adduction exercise

Usual rehabilitation program

ACTIVE COMPARATOR

The rehabilitation program will be an active exercise based on the available literature and considers the clinical experience in managing groin injuries. An experienced physical therapist will supervise the rehabilitation program for two sessions weekly for eight weeks, with difficulty and volume progressing incrementally. Sessions will last between 30 and 120 minutes.

Other: Usual rehabilitation program

Interventions

The CAE is a progressive eccentric training program that enhances hip adduction. The fact that exercises are done with a partner and do not require special equipment makes them more useful in a team setting. The MPCA program, adapted from the original CAE, included six progressive levels for eight weeks, beginning with an assisted isometric adduction hold (level 1) and progressing incrementally to a complete CAE as the original exercise (level 6). The progression in levels will depend on a pain score ≤ 4/10 numeric rating scale (NRS) in the adductor squeeze test and post-session DOMS score ≤ 4/10 NRS.

Copenhagen adduction exercise

The usual rehabilitation program will include leg swings extension/flexion, leg swings abduction/adduction, standing hip circles, isometric standing hip adduction using elastic bands, stretching exercises, balance training on a wobble board, and single leg coordination exercises. Difficulty and volume are progressing incrementally.

Usual rehabilitation program

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Soccer players aged between 18 to 40 years.
  • They have groin pain or injury within two months during sports.
  • Pain or tenderness on palpation of adductors in clinical examination.
  • Pain on resisted hip adduction movement in clinical examination.
  • Desire to continue the sport at the same level.

You may not qualify if:

  • Groin pain or injury not involving the adductors on clinical examination.
  • They have any clinical finding indications of femoral or inguinal hernia.
  • Evidence of prostatitis, chronic urinary tract disease.
  • Evidence of hip joint osteoarthritis or hip joint disease.
  • Bursitis of the hip or groin region.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam Abdulrahman Bin Faisal University

Dammam, Saudi Arabia

Location

Related Publications (11)

  • Delahunt E, Thorborg K, Khan KM, Robinson P, Holmich P, Weir A. Minimum reporting standards for clinical research on groin pain in athletes. Br J Sports Med. 2015 Jun;49(12):775-81. doi: 10.1136/bjsports-2015-094839.

    PMID: 26031644BACKGROUND
  • Haroy 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.

    PMID: 28806100BACKGROUND
  • 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.

    PMID: 26589483BACKGROUND
  • Jansen JA, Mens JM, Backx FJ, Kolfschoten N, Stam HJ. Treatment of longstanding groin pain in athletes: a systematic review. Scand J Med Sci Sports. 2008 Jun;18(3):263-74. doi: 10.1111/j.1600-0838.2008.00790.x. Epub 2008 Apr 6.

    PMID: 18397195BACKGROUND
  • Mosler AB, Crossley KM, Thorborg K, Whiteley RJ, Weir A, Serner A, Holmich P. Hip strength and range of motion: Normal values from a professional football league. J Sci Med Sport. 2017 Apr;20(4):339-343. doi: 10.1016/j.jsams.2016.05.010. Epub 2016 Aug 23.

    PMID: 28185809BACKGROUND
  • Serner A, Jakobsen MD, Andersen LL, Holmich P, Sundstrup E, Thorborg K. EMG evaluation of hip adduction exercises for soccer players: implications for exercise selection in prevention and treatment of groin injuries. Br J Sports Med. 2014 Jul;48(14):1108-14. doi: 10.1136/bjsports-2012-091746. Epub 2013 Mar 19.

    PMID: 23511698BACKGROUND
  • Thorborg K, Holmich P, Christensen R, Petersen J, Roos EM. The Copenhagen Hip and Groin Outcome Score (HAGOS): development and validation according to the COSMIN checklist. Br J Sports Med. 2011 May;45(6):478-91. doi: 10.1136/bjsm.2010.080937.

    PMID: 21478502BACKGROUND
  • Thorborg K, Tijssen M, Habets B, Bartels EM, Roos EM, Kemp J, Crossley KM, Holmich P. Patient-Reported Outcome (PRO) questionnaires for young to middle-aged adults with hip and groin disability: a systematic review of the clinimetric evidence. Br J Sports Med. 2015 Jun;49(12):812. doi: 10.1136/bjsports-2014-094224. Epub 2015 Jan 13.

    PMID: 25586913BACKGROUND
  • Nussbaumer S, Leunig M, Glatthorn JF, Stauffacher S, Gerber H, Maffiuletti NA. Validity and test-retest reliability of manual goniometers for measuring passive hip range of motion in femoroacetabular impingement patients. BMC Musculoskelet Disord. 2010 Aug 31;11:194. doi: 10.1186/1471-2474-11-194.

    PMID: 20807405BACKGROUND
  • Holmich 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.

    PMID: 9989713BACKGROUND
  • Alsirhani AA, Muaidi QI, Nuhmani S, Thorborg K, Husain MA, Al Attar WSA. The effectiveness of the Copenhagen adduction exercise on improving eccentric hip adduction strength among soccer players with groin injury: a randomized controlled trial. Phys Sportsmed. 2024 Oct;52(5):497-506. doi: 10.1080/00913847.2024.2321958. Epub 2024 Mar 1.

Study Officials

  • Qassim Muaidi, Professor

    Imam Abdulrahman Bin Faisal University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 14, 2022

First Posted

October 21, 2022

Study Start

January 15, 2023

Primary Completion

April 3, 2023

Study Completion

April 27, 2023

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations