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.: PACTR201804003311164 Date of Approval: 07/04/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Diet control program and exercise effect on obese children with chronic kidney disease
Official scientific title Effect of diet control program and exercise on obese children with chronic kidney disease
Brief summary describing the background and objectives of the trial Diet control program and exercise have improving effect on obese children with Chronic Kidney Disease so this study conducted to investigate the effect of diet control program and exercise on obese children with chronic kidney disease (after successive three months of treatment).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Chronic kideny disease, obsity,Paediatrics,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 03/10/2016
Actual trial start date 05/12/2016
Anticipated date of last follow up 04/03/2017
Actual Last follow-up date 16/07/2018
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL Effect of diet control program and exercise on obese children with chronic kidney disease
Secondary Ids Issuing authority/Trial register
The research ethical committee number approval is (P.T.REC/012/001861)
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 radomisation table created by a computer software program Numbered containers Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Gruop A As described by the physician Three months Routine medical treatment 15
Experimental Group Group B Routine medical treatment and diet control program and exercise three times per week Three months Routine medical treatment, diet control program and exercise in form of aerobic exercise Exercise was performed on bicycle ergometer for 20 minutes stages: (at 15W for 20min/d, 4d/wk) and walking on treadmill for 10 minutes followed by physical exercise three times per week for three months of treatment. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children with first two stages of chronic kidney disease None of the patients were on tube feeding or parenteral nutrition. They have no other neurological disorders that affect balance or mentality. (e.g. epilepsy) They can follow orders and they have average mentality They have no visual or hearing defects that can affect their performance They had surgical procedures up to 3 months (for orthopedic surgery) Patients who had congenital or acquired skeletal deformities Patients who had any cardiopulmonary dysfunctions Patients who had any neurological deficits such as convulsions, involuntary movements or receiving muscle relaxants 12 Year(s) 16 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 11/03/2018 Research Ethical committee, Faculty of Physical Therapy, Cairo University.
Ethics Committee Address
Street address City Postal code Country
El - Tahrir st. - in front of ben El - Sarayat Traffic Dokki - Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Diet control program and exercise may be helpful in improving obese children with first two stages Chronic Kidney Disease At the end of the treatment period
Secondary Outcome Lipid profiles improvement was noticeable At the end of the treatment period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pediatric Nephrology unit, Cairo University Elmanial St ElGiza 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faten Eltohamy Mostfa Elyawar street Ain Shamas,Cairo Egypt
Alaa Ramzy Elrafaay street Helwan,Cairo 11731 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alaa Ramzy Elrafaay street Helwan,Cairo 11731 Egypt Hospital
Primary Sponsor Faten Eltohamy Mostfa Elyawar street Ain Shamas,Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Pediatric Nephrology unit, Cairo University El-Kasr al ainy hospital Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alaa Morgan alaaramzy1980@yahoo.com +201225828140 Elrafaay street
City Postal code Country Position/Affiliation
Helwan,Cairo 11731 Egypt Fellow physiotherapy at El-Kasr al ainy hospital, Cairo university.
Role Name Email Phone Street address
Public Enquiries Alaa Morgan alaaramzy1980@yahoo.com +201225828140 Elrafaay street,Hadaak Helwaan
City Postal code Country Position/Affiliation
Cairo 11731 Egypt Fellow physiotherapy at El-Kasr al ainy hospital, Cairo university.
Role Name Email Phone Street address
Scientific Enquiries Alaa Morgan alaaramzy1980@yahoo.com +201225828140 Elrafaay street,Hadaak Helwaan
City Postal code Country Position/Affiliation
Cairo 11731 Egypt Fellow physiotherapy at El-Kasr al ainy hospital, Cairo university.
Role Name Email Phone Street address
Scientific Enquiries Faten Ali alifaten@rocketmail.com 01019200420 Mostfa Elyawar street, Ain Shamas
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer at faculty of physical therapy. Delta University for science and technology
REPORTING
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Changes to trial information