Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201610001808141 Date of Approval: 04/10/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of core stability exercises on trunk and hip muscles performance in healthy adults
Official scientific title Effect of core stability exercises on trunk and hip muscles strength in healthy adults
Brief summary describing the background and objectives of the trial core stability is the function of lumbopelvic hip complex. it is the ability to maintain proximal stability for distal mobility. The purpose of the current study was to investigate the effect of beginners core stability exercises on trunk flexors, extensors, hip flexors, extensors, abductors, and adductors peak torques in healthy adults.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied healthy adults - trunk and hip muscle strength
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2012
Actual trial start date 15/05/2012
Anticipated date of last follow up 01/09/2012
Actual Last follow-up date 10/09/2012
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 32
Recruitment status Stopped early/ terminated
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised simple random sampling by computer software program other investigator did the allocation Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group core training (McGill protocol) trice a week six weeks core training (McGill protocol) was pergormed by the experimental group trice a week for six weeks 17
Control Group no treatment no dose six weeks control group did not receive any treatment 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The subjects included in the study met the following criteria: - All participants were healthy (free from musculoskeletal injuries, deformities and not taking medications for pain at the time of testing). - Trunk and hip muscles strength of at least grade four as assessed by manual muscle test. - Body mass index ranges from 18 to 25 kg/m². - Normal flexibility of the lower back muscles of more than 5 cm as assessed by modified Schober test. (Appendix I). - Normal flexibility test of hip flexors as assessed by modified Thomas test (Hip flexor test). Subjects were excluded if there was: - Any previous musculoskeletal or neurological deficits. - Previous experience with stabilization exercises. 18 Year(s) 25 Year(s) Both
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 03/04/2012 Research ethics committee of faculty of physical therapy, Cairo University
Ethics Committee Address
Street address City Postal code Country
Cairo university Giza 16126 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome isokinetic trunk strength isokinetic trunk flexors peak torques isokinetic trunk extensors peak torques
Secondary Outcome isokinetic hip strength isokinetic hip flexors peak torques isokinetic hip extensors peak torques isokinetic hip abductors peak torques isokinetic hip adductors peak torques
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy Cairo University 7 aHMED EZZAYAT STREET, Bien ElSaryat, Giza, Egypt Giza 16216 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo University Cairo University Giza 16216 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Cairo University Giza 16126 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Azza Mohammed Abd El Mohsen 7 aHMED EZZAYAT STREET, Bien ElSaryat, Giza, Egypt Giza 16126 Egypt
Sobhy Mahmoud Abd Elwahid 7 aHMED EZZAYAT STREET, Bien ElSaryat, Giza, Egypt Giza 16126 Egypt
Salam Mohammed Elhafez 7 aHMED EZZAYAT STREET, Bien ElSaryat, Giza, Egypt Giza 16126 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Azza Abd El Mohsen DR_AZZAMOHAMMED@YAHOO.COM 01145046304 7 Ahmed Ezzayat street, Bien Essarayat
City Postal code Country Position/Affiliation
GIZA 16126 Egypt assistant lecturer, faculty of physical therapy, Cairo University
Role Name Email Phone Street address
Public Enquiries Azza Abd El Mohsen dr_azzamohammed@yahoo.com 01145046304 7 Ahmed Ezzayat street, Bien Essarayat
City Postal code Country Position/Affiliation
GIZA 16126 Egypt assistant lecturer, faculty of physical therapy, Cairo University
Role Name Email Phone Street address
Scientific Enquiries Azza Abd El Mohsen dr_azzamohammed@yahoo.com 01145046304 7 Ahmed Ezzayat street, Bien Essarayat
City Postal code Country Position/Affiliation
GIZA 16126 Egypt assistant lecturer, faculty of physical therapy, Cairo University
REPORTING
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