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.: PACTR201804003248173 Date of Approval: 24/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Whole Body Vibration Training on Bone Mineral Density and Functional Capacity in Children with Thalassemia
Official scientific title Effect of Whole Body Vibration Training on Bone Mineral Density and Functional Capacity in Children with Thalassemia
Brief summary describing the background and objectives of the trial Children with thalassemia have impaired bone matrix, defective mineralization and reduced bone formation rate with iron deposition within bone. Other risk factors that affect bone mass in children with thalassemia, include ineffective erythropoiesis that leads to bone marrow hyperplasia and cortical thinning. Children with thalassemia are less physically active than their healthy peers and generally have decreased muscle strength and flexibility. This leads to feeling of fatigue as well as anxiety and depression. Functional capacity is reduced in children with thalassemia major due to the complications of the disease and the overprotection by their parents who do not encourage physical activity. Therefore, the lack of physical activity is considered a predisposing factor for developing osteoporosis in patients with thalassemia and muscle activity has to be encouraged in these patients. Up to date, the clinical effect of whole body vibration (WBV) on bone mineral density (BMD) and functional capacity in children with thalassemia is still not investigated. Therefore, the purpose of this study was to investigate the effectiveness of WBV training on BMD and functional capacity in children with ¿-thalassemia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Other, thalassemia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 15/09/2017
Actual trial start date 20/09/2017
Anticipated date of last follow up 20/03/2018
Actual Last follow-up date 20/03/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 40
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Using computer-generated random numbers Following the baseline measurements, the randomization process was conducted for 39 children using computer-generated random numbers. Stratification of subjects according to age and gender was conducted to be equally distributed in both groups. Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Whole body vibration training A peak-to-peak displacement of 2 mm, and the frequency of vibration was set at 25-30 Hz for 10 repetitions (30 to 60 s) with a 1-min rest in between. Three times per week for 24 weeks treatment duration The children were instructed to stand on the platform without shoes in squatting position with flexed knees at 30 degrees 19 Active-Treatment of Control Group
Experimental Group Medical treatment + Physical therapy program + Whole body vibration training A peak-to-peak displacement of 2 mm, and the frequency of vibration was set at 25-30 Hz for 10 repetitions (30 to 60 s) with a 1-min rest in between. Three times per week for 24 weeks treatment duration The children were instructed to stand on the platform without shoes in squatting position with flexed knees at 30 degrees 19
Control Group Medical treatment + Physical therapy program Three sessions per week for 24 weeks Each session lasted one hour, three sessions per week for 24 weeks Gentle stretching exercises, strengthening exercises, balance and proprioceptive training 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children who had confirmed diagnosis of ¿-thalassemia major and their BMD at baseline at Z-score less than -1 at the lumber spine, femoral neck and the total body were included in the study children who had treated with bisphosphonate therapy in the previous 6 months. A history of bone marrow transplant or musculoskeletal deformities and cardiac complications were excluded from the study 6 Year(s) 10 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 10/09/2017 Cairo University ethics committee
Ethics Committee Address
Street address City Postal code Country
Abdelkhalik Tharwat street Cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Bone mineral density BMD: by using DEXA at the lumbar spine, femoral neck and total body was conducted before and after 6 months of the treatment program
Primary Outcome Functional capacity Functional capacity was measured by using the six-minute walk test (6MWT). The 6MWT was conducted before and after 6 months of the treatment program.
Secondary Outcome No secondary outcomes were present in the current study No secondary outcomes were present in the current study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Specialized Pediatric Hospital Kasr AL-Aini street Cairo 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo University Abdelkhalik Tharwat street Cairo 12613 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Abdelkhalik Tharwat street Cairo 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sobhy Mahmoud Aly Abdelkhalik Tharwat street Cairo 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Eid mohamed.eid27@yahoo.com 00966597620659 Abdelkhalik Tharwat street
City Postal code Country Position/Affiliation
Cairo 12613 Egypt Assistant Prof at the department of pediatric rehabilitation
Role Name Email Phone Street address
Public Enquiries Mohamed Eid mohamed.eid27@yahoo.com 00966597620659 Abdelkhalik Tharwat street
City Postal code Country Position/Affiliation
Cairo 12613 Egypt Assistant Prof at the department of pediatric rehabilitation
Role Name Email Phone Street address
Scientific Enquiries Sobhy Aly drsobhymahmoud@gmail.com 00966568582276 Abdelkhalik Tharwat street
City Postal code Country Position/Affiliation
Cairo 12613 Egypt Assistant Prof at the department of Biomechanics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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