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.: PACTR201810754318796 Date of Approval: 01/10/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFICACY OF ADDING POST-TRAINING NORDIC EXERCISES TO HAMSTRING INJURY PREVENTION PROGRAM IN SOCCER PLAYERS
Official scientific title EFFICACY OF ADDING POST-TRAINING NORDIC EXERCISES TO HAMSTRING INJURY PREVENTION PROGRAM IN SOCCER PLAYERS
Brief summary describing the background and objectives of the trial The main objective of the study is to apply a clinical trial to find a new program more effective in reducing the total injuries for the team compared to the last season, initial, recurrent injuries, and severity of each hamstring injury for soccer players, by applying the NH as pre and post-training program as experimental group, and applying NH as pre-training program only, under physiotherapist supervision and with the highest compliance possible.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) NHE
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/12/2017
Actual trial start date 01/01/2018
Anticipated date of last follow up 01/04/2018
Actual Last follow-up date 01/04/2018
Anticipated target sample size (number of participants) 34
Actual target sample size (number of participants) 32
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 Numbered containers Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intervention group (2 session/week) except the first week was once/week, this intervention group received 50 NH sessions The protocol was 12 weeks The players do a pre and post NH, with the warming up and cooling down, but in different doses where the post-training Nordic was less in number and intenisty. 17
Control Group Control group 2 session / week except the first week was once/week. received total 25 NH sessions. 12 weeks program. Performe only the NH as pre-training program beside traditional warming up and cooling down exercises. 17 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- All players were males with normal healthy subjects. 2- Ages of players ranged from 21 to 35 years. 3- All players were active players. 4- The participants were free of any hamstring injury at least for 6 months before applying the protocol. 5- All players entered the study had their signed consent form 1. Commencing participation in a team after the start of the trial. 2. Any previous lower extremity injury that required medical attention in the past 6 months. 3. Any systemic disease, cardiovascular disease, neurological disorders. 4. Any surgery in the previous year. Adult: 19 Year-44 Year 21 Year(s) 35 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 01/01/2018 Cairo University Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El Zayyat Street, Dokki, Giza, Egypt. Cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The initial and recurrent injury rates were decreased in both the intervention and control group, but the intervention was with more decrease than the control in which the intervention was only one hamstring strain injury that lasts for one day with no recurrences, but the control group was 3 hamstring injuries that lasted from 2-3 days, and 1 recurrent injury and, so total 4 injuries and one recurrent compared to last season 13 injuries and recurrent 7 injuries one of them was severe and exceeded 2 months absence of play and 5 was moderate injury with average week to 10 days absence of play. The initial, recurrent injury in numbers, and severity of each injury measured on termination of the 12 week program
Secondary Outcome increase the performance and sprinting velocity After the completion of the 12 week program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sporting club Abou Quer street, AR Riyadah, qesm Sidi Gaber Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hend Adel Abdelhalim Dorgham Miamy, Elbekbashy street, beside Alexcan Alexandria Egypt personal sponsoring for my own study
COLLABORATORS
Name Street address City Postal code Country
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 Researcher physiotherapist
Role Name Email Phone Street address
Scientific Enquiries Ahmed Elerian dr_ahmed_elerian77@yahoo.com 201116752333 7 Ahmed Elzayat street, Dokki, Giza, Egypt
City Postal code Country Position/Affiliation
Alexandria Egypt Supervisor for the thesis
Role Name Email Phone Street address
Public Enquiries Hend Dorgham drhenddorgham@rocketmail.com 201003752883 Miamy , Elbekbashy street.
City Postal code Country Position/Affiliation
Alexandria Egypt Researcher physiotherapist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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