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.: PACTR201907504136763 Date of Approval: 24/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Physical Activities on Children with Juvenile Idiopathic Arthritis
Official scientific title Efficacy of Physical Activities on Children with Juvenile Idiopathic Arthritis
Brief summary describing the background and objectives of the trial Juvenile idiopathic arthritis (JIA) is one of the serious chronic rheumatic disorders in children and adolescents which results in less physical activities and restlessness hours than their peer. The study aims to assess the efficacy of physical fitness training exercises on aerobic capacity and muscular strength of children with JIA.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/01/2019
Actual trial start date 01/01/2019
Anticipated date of last follow up 30/04/2019
Actual Last follow-up date 30/04/2019
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 65
Recruitment status Completed
Publication URL https://www.researchgate.net/publication/333385874_Efficacy_of_Physical_Activities_on_Children_with_Juvenile_Idiopathic_Arthritis_A_Randomized_Controlled_Trail
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group physical agents 3 times per week 12 weeks 1. hot packs 2. TENS 3. Strengthening exercises 33 Active-Treatment of Control Group
Experimental Group physical activities 3 times/week 12 weeks 1. swimming pool 2. bicycle ergometer 3. treadmill 4. hot packs 5. TENS 6. Strengthening exercises 32
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Medical diagnosis of juvenile idiopathic arthritis was conducted by a pediatric rheumatologist according to the criteria of international league against rheumatology. 2) Children were able to understand and follow verbal commands and instructions and co-operate with testing and training protocols. 1) Children complained from severe pain according to verbal pain intensity scale. 11 2) Children had cardiac, pulmonary or metabolic disease. 3) Children had active features of systemic arthritis. 4) Children had fixed deformity (bony or soft tissue contracture) of both upper and lower limbs. 5) Children had previous surgical interventions which may include soft tissues release, synovectomies, arthodeses and joints replacements. 6) Children had visual or auditory defects. Child: 6 Year-12 Year 8 Year(s) 12 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 09/09/2018 Faculty of Physical therapy
Ethics Committee Address
Street address City Postal code Country
7 ahmad zyaed street Giza 12613 Egypt
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 09/09/2018 Research Ethical Committee Faculty of physical therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzayat, Dokki Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome peak oxygen uptake (Vo2 peak) during an incremental treadmill test and muscle strength assessed by isokinetic testing device. after 12 weeks
Secondary Outcome pain measurements post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kafrelsheikh Governorate Al Gish Kafrelsheikh Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Wanees M. Badawy Al gish street Kafrelsheik Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Wanees Mohamed Alamir 7 ahmad elzayaed street giza Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mahmoud Labib Al gish street Kafrelsheikh 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Ibrahim mohamedbedier32@yahoo.com +201201857949 al gish
City Postal code Country Position/Affiliation
Kafrelsheikh Egypt Assistant professor Kafrelsheikh University.
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Labib Mahmoudlabib80@yahoo.com +2026406066 Al gish
City Postal code Country Position/Affiliation
Kafrelsheikh Egypt Lecuturer Kafrelsheikh University
Role Name Email Phone Street address
Public Enquiries Hamed Khozamy h_khozamy@yahoo.com +201010066026 Al gish
City Postal code Country Position/Affiliation
Kafrelsheikh University Egypt Lecturer Kafrelsheikh University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the peak oxygen uptake= 28.19 ml/kg/min, peak torque of knee extensors = 40.13 Nm and flexors = 18.24 Nm of right lower limb and peak torque of wrist extensors= 3.12 Nm and flexors = 4.89 Nm of right upper limb during the concentric contraction mode. Clinical Study Report,Study Protocol 2 years primary ID
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.researchgate.net/publication/333385874_Efficacy_of_Physical_Activities_on_Children_with_Juvenile_Idiopathic_Arthritis_A_Randomized_Controlled_Trail Yes Cardiopulmonary capacity testing Comparison of pre intervention Vo2 peak means of both groups revealed that there were no statistically significant differences between them (p < 0.05). A significant increase in the means of Vo2 peak was found in the study and control groups post treatment (p = 0.001, 0.01 respectively). Moreover, a significant difference was detected between both groups post intervention with remarkable improvement in the study group (P = 0.014). Muscle performance testing using the isokinetic dynamometer In comparison of pre intervention values of peak torque of knee extensors and flexors, and peak torque of wrist extensors and flexors, there were no statistically significant differences of means between both groups (p < 0.05). However the both groups showed improvement post intervention (p < 0.05). The comparison between the mean values of the muscles’ torques post intervention revealed that there were significant differences (p < 0.05) between both groups in favor of the study group. 23/07/2019 23/07/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.researchgate.net/publication/333385874_Efficacy_of_Physical_Activities_on_Children_with_Juvenile_Idiopathic_Arthritis_A_Randomized_Controlled_Trail
Changes to trial information