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.: PACTR201602001478123 Date of Approval: 19/02/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of specific weight bearing program on balance and lower extremity muscles strength in osteopenia
Official scientific title Weight bearing exercise for better balance (WEBB) program improves strength, balance and bone mineral density in osteopenia: a randomized trial
Brief summary describing the background and objectives of the trial Exercise is widely recommended to preserve bone health and muscles strength and reduce risk of falling by maintaining postural balance. The primary purpose of this study was to investigate the effect of weight bearing exercise for better balance (WEBB) program on hip flexors¿, extensors¿, abductors¿, and adductors¿ and knee flexors¿ and extensors¿ strength and balance in osteopenia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 18/01/2015
Actual trial start date 26/02/2015
Anticipated date of last follow up 19/10/2015
Actual Last follow-up date 26/10/2015
Anticipated target sample size (number of participants) 78
Actual target sample size (number of participants) 24
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
P.T.REC/012/00731
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 A total of 78 participants were assessed, and 54 who did not meet the inclusion criteria were excluded. Twenty-four participants were included in the study and were randomly assigned to an experimental group or a control group, according to a computer-generated random assignment list Simple randomization using a randomization table created by a computer software program Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Weight bearing exercise for Better Balance (WEBB) program training program in form of strength and balance exrcises six weeks weight bearing program 12
Control Group no intervention no intervention six weeks just control without intervention 12 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: 1-They were diagnosed with osteopenia with a T-score value between -1 and -2.5 SD of the normal mean value of young persons of same sex. 2-They don¿t participate in sports or athletic activities. 3-They have hip and knee muscles strength of at least grade four as assessed using manual muscle test. Subjects were excluded if: 1-There was any musculoskeletal, neurological, cardiovascular, or respiratory problems. 2-They were receiving medications that lead to bone loss. 3-They had hyperthyroidism or hyperparathyroidism. 4-They had symptoms of vertigo, dizziness or any vestibular problems. 5-They had poor diet with lack of calcium and vitamin D. 50 Year(s) 60 Year(s) Female
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 18/01/2015 faculty of physical therapy, cairo university
Ethics Committee Address
Street address City Postal code Country
Ahmed ElZayat street, Dokki, Egypt Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcomes were isokinetic PT/BW values for hip and knee muscles. -Before training -six weeks after training
Secondary Outcome Balance score of Berg Balance Scale -before training -six weeks after training of WEBB program
Secondary Outcome Bone mineral density -before training -six weeks after training
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El-Haram Hospital El-Haram street, Giza Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
cairo university Giza Giza 12612 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university Giza Giza 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ghada Mohammed El Hafez Giza Giza 12612 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Azza Abd El Mohsen dr_azzamohammed@yahoo.com 01145046304 17 Masgid El Rahma street, Fesal, Giza
City Postal code Country Position/Affiliation
Giza 12612 Egypt assistant lecturer of Biomechanics, Faculty of Physical Thrapy, Cairo University
Role Name Email Phone Street address
Public Enquiries Ghada El Hafez egyptsalam@yahoo.co.uk 0109415932 12 Ahmed El ZAYAT Street, Giza, Egypt
City Postal code Country Position/Affiliation
Giza 12612 Egypt professor of Biomechanics, faculty of physical Therapy, Cairo university
Role Name Email Phone Street address
Scientific Enquiries Azza Abd El Mohsen dr_azzamohammed@yahoo.com 01145046304 17 Masgid El Rahma street, Fesal, Giza
City Postal code Country Position/Affiliation
Giza 12612 Egypt assistant lecturer of Biomechanics, Faculty of Physical Thrapy, Cairo University
Role Name Email Phone Street address
Scientific Enquiries Azza Abd El Mohsen dr_azzamohammed@yahoo.com 01145046304 17 Masgid El Rahma street, Fesal, Giza
City Postal code Country Position/Affiliation
Giza 12612 Egypt assistant lecturer of Biomechanics, Faculty of Physical Thrapy, Cairo University
REPORTING
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