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.: PACTR201604001541203 Date of Approval: 25/03/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title the effect of core and treadmill training on isokinetic core muscles strength and skeletal mineralization
Official scientific title the effect of core and treadmill training on isokinetic core muscles strength and skeletal mineralization
Brief summary describing the background and objectives of the trial The purpose of this study was to investigate the effect of core and treadmill training on isokinetic core muscles strength and skeletal mineralization in postmenopausal women with osteoporosis.
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 06/07/2014
Actual trial start date 25/07/2014
Anticipated date of last follow up 12/10/2015
Actual Last follow-up date 12/10/2015
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
cairo university- faculty of physical therapy ethics committee cairo university- faculty of physical therapy ethics committee
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 randomisation using a randomisation table from a statistics book Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group core training 5-8 cycles, hold this posture for 7-8 seconds , three sessions weekly for three months 3 months Warm up exercise, Curl up exercise, Isometric side-bridge, Bird-dog exercise 10
Experimental Group Treadmill training Warm-up at 45% of heart rate reserve. Effort increased to 65% of the subjects' heart rate reserve. for 3 months The treadmill was set at no incline. At the first week, patients completed two miles per session, at the second week 2.5 miles, at the third week three miles and the fourth week 3.5 miles. Training sessions were repeated for three months. 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Postmenopausal women with at least one year post menopause. 2.Diagnosed as osteoporotic with BMD of 2.5 SD or more below the young adult mean. 3.They didn¿t use any medication that alters bone mineral density. 4.They didn¿t use estrogen hormone therapy. 5.They had a sedentary life style (no regular physical exercise or weight training program for at least two years ago). 6.They had not apparent occupational or leisure time responsibilities that impede their participation. 7.They had good self-reported general health, and balanced food intake. 1.History of severe renal, hepatic, endocrine or cardiac diseases. 2.Progressive neurological disease that alters the trunk and /or lower limbs physical conditions. 3.Musculoskeletal problems such as mechanical problems, previous fractures, leg length discrepancy, and structural deformities as scoliosis. 4.Symptoms of vertigo or dizziness. 5.History of smoking or currently are smokers. 6.Uncontrolled hypertension or diabetes. 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 17/06/2014 CAIRO university- faculty of physical therapy ethics committee
Ethics Committee Address
Street address City Postal code Country
giza- bein elsarayat GIZA 002 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome hip flexors, extensors, abductors, adductors, trunk flexors and extensors isokinetic peak torques pre-intervention post-intervention(after 3 months).
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
cairo university- faculty of physical therapy. Giza- bein el-sarayat- faculty of physical therapy GIZA 002 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding 6- october GIZA 002 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof. Salam el-hafez faculty of physical therapy- cairo university. GIZA 002 Egypt University
COLLABORATORS
Name Street address City Postal code Country
DR.Hossam fawaz. faculty of physical therapy- cairo university. GIZA 002 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator DR.HAMADA MOHAMED HAMADA rabiallah97@yahoo.com 00201117893697 faculty of physical therapy, cairo university
City Postal code Country Position/Affiliation
GIZA 002 Egypt
Role Name Email Phone Street address
Principal Investigator Prof. salam elhafez egyptsalam@yahoo.co.uk 00201117922990 cairo university, faculty of physical therapy
City Postal code Country Position/Affiliation
GIZA 002 Egypt
Role Name Email Phone Street address
Public Enquiries mohamed essa mohamedmohamed1990mohamed@yahoo.com 00201285584224 6 october city- 8th district- block 31.
City Postal code Country Position/Affiliation
Giza 002 Egypt
Role Name Email Phone Street address
Scientific Enquiries mohamed essa mohamedmohamed1990mohamed@yahoo.com 00201285584224 6- october
City Postal code Country Position/Affiliation
GIZA 002 Egypt
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information