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.: PACTR202212863607265 Date of Approval: 21/12/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of a multicomponent physical activity intervention on Tunisian preschool children's postural control
Official scientific title The effect of a multicomponent physical activity intervention on preschool children's postural control
Brief summary describing the background and objectives of the trial Postural control is a key factor for good motor development, physical well-being, literacy skills and school readiness in typically developed preschoolers. Therefore, the aim of this study was to evaluate the effect of a multicomponent intervention program on postural control in preschool children aged 5-6 years compared to others who practice kindergarten free play program only.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/10/2021
Actual trial start date 05/10/2021
Anticipated date of last follow up 30/06/2022
Actual Last follow-up date 07/07/2022
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 61
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
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group multicomponent physical activity intervention 8 months After the initial assessment, the intervention group was enrolled in a multi-component physical education program for 8 months, the children had 2 sessions per week, one of which was a structured physical activity session to promote motor skills and the other was a dance session. For the Structured Physical Activity session, each class (lasting 60min) included a warm-up and social interaction phase (_5min) a central phase (_50min) including specific activities to develop fundamental motor and sensory skills in preschool children; a recovery phase (_5min) to relax the children and explore their level of satisfaction. As for the dance session: The course structure included: • Warming up with dynamic stretching exercises and music (Chatzopoulos et al., 2015; Lykesas et al., 2020). 5 minutes • Introduction of dance theme and dance steps. 10 minutes • Practice the dance steps. 25mins • Dance improvisation; search for personal expression. 5 minutes At the end of the intervention, the preschoolers were reassessed 31
Control Group unstructured free play 8 months have 20min per day of free play as physical activity program 30 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
aged 5 years old typically developed physical disabilities children with any developmental disorder visual disabilities vestibular disabilities practice any extra physical activity Preschool Child: 2 Year-5 Year 59 Month(s) 63 Month(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 08/02/2020 Comite de Protection des personnes Sud C.P.P.SUD
Ethics Committee Address
Street address City Postal code Country
Road Manzel Cheker Sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postural control pre intervention and post intervention after 8 months
Secondary Outcome physical activity level pre intervention
Secondary Outcome anthropometric measurements pre intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Labib kindergarten Mahdia road Sfax 3011 Tunisia
kotteb Al Rahim mahdia road sfax 3011 Tunisia
Kotteb Al Moumen Road Sidi Mansour Sfax Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
khouloud Mnejja mahdia road km6 Sfax 3011 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Laboratory EM2S Airport road Sfax 3000 Tunisia laboratory
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Khouloud Mnejja khouloudmnejja19@gmail.com 26247909 Mahdia road
City Postal code Country Position/Affiliation
Sfax 3011 Tunisia LR19JS01
Role Name Email Phone Street address
Public Enquiries Khouloud Mnejja khouloudmnejja19@gmail.com 26247909 Mahdia road
City Postal code Country Position/Affiliation
Sfax 3011 Tunisia LR19JS01
Role Name Email Phone Street address
Scientific Enquiries Khouloud Mnejja khouloudmnejja19@gmail.com 26247909 Mahdia road
City Postal code Country Position/Affiliation
Sfax 3011 Tunisia LR19JS01
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after disidentification (text, tables, figures, and appendices) Informed Consent Form 12 months following the study publication Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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