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.: PACTR201911718624716 Date of Approval: 19/11/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Relation Between Body Mass Index and Lung Functions in Obese and Over weighted Children with Down Syndrome
Official scientific title Relation Between Body Mass Index and Lung Functions in Obese and Over weighted Children with Down Syndrome
Brief summary describing the background and objectives of the trial The body mass index (BMI) is the metric currently in use for defining anthropometric height/weight characteristics and for classifying (categorizing) them into groups Obesity has been defined as an abnormal and excessive fat accumulation that may impair health in practice. Respiratory function is a term used to describe how well the lungs work in helping a person breathes. During breathing, oxygen is taken into the lungs, where it passes into the blood and travels to the body’s tissues.The purpose of the study is to compare pulmonary functions among eutrophic, overweight and obese down syndrome.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Genetic Diseases,Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/10/2019
Actual trial start date 03/10/2019
Anticipated date of last follow up 06/11/2019
Actual Last follow-up date 09/11/2019
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Completed
Publication URL https://www.seronijihou.com/article/relation-between-body-mass-index-and-lung-functions-in-obese-and-overweight-children-with-down-syndrome
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group measurement using BMI 30 min one month applying the Body Mass Index equation same as adults 45 Active-Treatment of Control Group
Experimental Group Pulmonary function tests using Spirometer 30min one month applying the Body Mass Index equation same as adults and measuring pulmonary functions using spiromety 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Ages range from 7-9 years from both genders. • The ability to understand and properly perform the tests involved in the study. • A history of cardiorespiratory, neuromuscular, rheumatic, and neurological diseases. • Any acute illness at the time of collection of data. • Forced expiratory volume in one second (FEV1) lower than 80% of the predicted Child: 6 Year-12 Year 7 Year(s) 9 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 29/09/2019 Faculty of Physical Therapy Ethical committee
Ethics Committee Address
Street address City Postal code Country
El zayat Giza 0003 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The outcome measures were the following: FEV1, FVC, FEV1/FVC ratio and PEFR. Then we recorded the results. 6weeks
Secondary Outcome The correlation between normal, overweight, obese down syndrome BMI and Pulmonary functions in this age group. 6weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy Cairo University El Zayat Giza 0003 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Radwa Saeid Abdulrahman El zayat Giza 0003 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical therapy El zayat Giza 0003 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mostafa Soliman Mostafa Ali El Zayat Giza 0003 Egypt
Mohamed Hanea Ahmed El zayat Giza 0003 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Radwa AbdulRahman radwakku@gmail.com 00201027713662 El zayat
City Postal code Country Position/Affiliation
Giza 0003 Egypt Lecturer in department of physical therapy of pediatrics
Role Name Email Phone Street address
Public Enquiries Mostafa Ali drmostafamalak9912@gmail.com 00201097720514 El Zayat
City Postal code Country Position/Affiliation
Giza 0003 Egypt lecturer in department of physical therapy in pediatrics
Role Name Email Phone Street address
Scientific Enquiries Mohamed Ahmed mohhanypt2002@gmail.com 00201093707581 El zayat
City Postal code Country Position/Affiliation
Giza 0003 Egypt Msc. in Pediatric Physical therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes here by we the authors and with the consent of the participants and patients we approve to share our results within 12 months from the end of our study. Statistical Analysis Plan 12 months controlled through third party to review the request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.seronijihou.com/article/relation-between-body-mass-index-and-lung-functions-in-obese-and-overweight-children-with-down-syndrome 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