Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201911817207971 Date of Approval: 19/11/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Prevention effects of the pre and post-training Nordic Hamstring Exercise on the adductor muscle injury for professional soccer players
Official scientific title Prevention effects of the pre and post-training Nordic Hamstring Exercise on the adductor muscle injury for professional soccer players
Brief summary describing the background and objectives of the trial The adductor injury rates are one the most common injuries in football. Finding an effective prevention program is very important. The aim of this study is to test the efficacy of applying a prevention program as two different protocols, one as pre and post Nordic training, and the other as pre training only beside the normal warming up and cooling down protocols, then comparing there injury rates to another team which performed no prevention protocol.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2019
Actual trial start date
Anticipated date of last follow up 30/03/2019
Actual Last follow-up date 01/06/2019
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group pre and post training nordic hamstring exercise two sessions weekly for 12 weeks the group is half of the experimental group and they performed the pre and post nordic hamstring exercise as warming up and cooling down protocol, beside there normal warming up and cooling down protocols, aiming to decrease the adducutor muscle injury rates. 51
Experimental Group intervention group 2 2 sessions weekly 12 weeks this group performed the pre training only training nordic training as warming up protocol beside the normal warming up, aiming to decrease the adducutor injury rates. 51
Control Group control group 2 session per week 12 weeks this group which was a full other team ( similar in all subjective data) didn't perform any prevention protocol, and the injury rates where collected at the end of the period, and they do only the normal warming up and cooling down protocols. 90 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Male football players with normal healthy conditions. Fisrt team players with age range 19-29 years old. All were active players. The participants were free of any adductor injury in the last 3 months. Participation in the team after starting the trial. Any previous lower extremity injury that require medical attention in the past 6 months. Any cardiovascular disease, neurological disorders. Any surgery in the previous year. Adult: 19 Year-44 Year 19 Year(s) 29 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/11/2019 Faculty of Physical therepy Research Ethical Committee.
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzayat Street, Dokki, Giza, Egypt Cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome of this study was the incidence of adductor injuries as initial, recurrent injuries. After full complition of the full trial.
Secondary Outcome Sevirity of adductor muscle injury in term of absence days, and compliance of the players to the protocol. After complition of the trial.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria football teams Sporting area, Alexandria, Egypt Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hend Adel Abdelhalim Dorgham Miami Elbekbashy street Alexandria 21614 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hend Adel Abdelhalim Dorgham Miami, elbekbashy street. Alexandria Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
David Rodriguez Sanz Faculty of sports science, Universidad Complutense de Madrid. Madrid Spain
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hend Dorgham drhenddorgham@rocketmail.com +201003752883 Miamy el bekbashy street
City Postal code Country Position/Affiliation
ALEXANDRIA Egypt PHD researcher
Role Name Email Phone Street address
Public Enquiries Ahmed Elerian dr_ahmed_elerian77@yahoo.com +201116752333 7 Ahmed Elzayyat street, Dokki
City Postal code Country Position/Affiliation
Cairo Egypt Professor in Cairo University
Role Name Email Phone Street address
Scientific Enquiries David Sanz davidrodriguezsanz@gmail.com +34677395217 Faculty of sports science, Univerisidad Complutense De Madrid
City Postal code Country Position/Affiliation
Madrid Spain Professor in Faculty of sports science Univerisidad Complutense De Madrid.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results are within 12 months if the study completion date. Clinical Study Report,Study Protocol 12 months Controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information