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.: PACTR202310549826921 Date of Approval: 03/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Tai-chi program improves physical performance measures in Down Syndrome adolescents and reduces parents’ symptoms of depression, anxiety and stress
Official scientific title Tai-chi program improves physical performance measures in Down Syndrome adolescents and reduces thier parents’ symptoms of depression, anxiety and stress
Brief summary describing the background and objectives of the trial Individuals with Down syndrome (DS) face unique physical, intellectual and cognitive challenges. Tai Chi, a mind-body practice known for improving balance, flexibility, and cognitive function, has been studied in various populations but remains underexplored in the context of DS. This study aims to investigate the effect of Tai-Chi training program on physical performance in Down DS adolescents and its influence on the psychological well-being of these parents. Twenty-five adolescents with DS (age 14.4±1.3 yrs.) were randomly assigned to a control group (CG, n=10) or a Tai-Chi training group (TG, n=15). The TG completed Tai-chi training program over 6-week period , while the CG maintained their normal daily activity. Before and after the training period, anthropometric parameters, lower limb explosive strength (LES), upper limb strength (ULS), flexibility and balance were assessed in all participants, as well as symptoms of depression, anxiety and stress in parents. Following 6-week Tai-Chi training program, significant improvements in LES, ULS, flexibility and static balance were observed in TG, whereas no improvements were observed in CG. Furthermore, significant reduction of depression, anxiety and stress scores were observed in parents’ TG after the training period. These findings suggest that Tai-Chi training is a feasible and effective approach to improve physical performance measures in DS adolescents, as well as reducing symptoms of depression, anxiety and stress in their parents.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Genetic Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 21/04/2022
Actual trial start date 03/05/2022
Anticipated date of last follow up 17/06/2022
Actual Last follow-up date 29/06/2022
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 25
Recruitment status Active, not recruiting
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tai Chi training program 18 sessions, 45-min per session 06 weeks (three sessions per week) The intervention was designed in 6 weeks with three sessions per week on non-consecutive days (even days, from 11 am to 11.45 am). Each training session included a 10-minute warm-up, including range of motion and stretching, 25 minutes of practicing TC techniques including five forms: Single whip, Waving hands in clouds (WHIC), Bruch knee, Playing the lute and Repulse Monkey (RM) of Yang style TC are practiced during the program. Based on the participants' abilities, this protocol is led by a trainer and three assistants witch continuously encouraged the participants verbally with the aid of physical guidance, patterning and attention cues, section by- section practice. Participants were instructed to follow along and imitate the instructor's posture and motions throughout the training session and those who participated in the course and mimicked the actions of the coach, at the end of the training, they were given a prize and a success certificate. Finally, each session ends with a 10-minutes cool-down (stretching, breathing exercises). 15
Control Group no intervention maintained their normal daily activity 06 weeks maintained their normal daily activity 10 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Regular participation in physical education activities of at least once per week. - age between 12 and 16 years. - Intelligence quotient (IQ) below 35. - No prior experience in martial arts. - The presence of significant physical disabilities that could potentially interfere with the exercise program (e.g., cardiac problems, epilepsy, injury, hearing impairment). - The use of drug therapies related to a psychiatric diagnosis. Adolescent: 13 Year-18 Year 12 Year(s) 16 Year(s) Male
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 24/02/2022 ethic committee of Research Unit Sport Sciences Health and Movement of High Institute of Sport and Physical Education of Kef
Ethics Committee Address
Street address City Postal code Country
University of Jendouba Higher Institute of Sport and Physical Education of Kef Boulifa University Campus Kef Tunisia. Kef 7100 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Tai Chi training program improved physical performance measures in Down Syndrome adolescents. Pre and post 06 weeks intervention
Secondary Outcome Tai-Chi training resulted in a significant decrease in depression , anxiety and stress in Training group parent’s. Pre and post training intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tajerouine Public Handicap School Kef Tunisia Tajerouine Tunisia Tajerouine 7150 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Research Unit Sport Sciences Health and Movement of High Institute of Sport and Physical Education of Kef Boulifa University Campus 7100 Kef Tunisia kef 7100 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NO NO NO 0000 Tunisia Individual
COLLABORATORS
Name Street address City Postal code Country
Ala Cherni City Jebabli Tajerouine Tajerouine 7150 Tunisia
Nejmeddine Ouerghi Dahmani Dahmani 7170 Tunisia
Nidhal Jebabli City Jebabli Tajerouine tajerouine 7150 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ala Cherni cherni19a@gmail.com +21646248605 City Jebabli Tajerouine
City Postal code Country Position/Affiliation
tajerouine 7150 Tunisia PhD student
Role Name Email Phone Street address
Scientific Enquiries Nejmeddine Ouerghi najm_ouerghi@hotmail.com 0021625300232 Dahmani
City Postal code Country Position/Affiliation
Dahmani 7170 Tunisia PhD researcher in High Institute of Sport and Physical Education of Kef
Role Name Email Phone Street address
Public Enquiries Nidhal Jebabli jnidhal@gmail.com +2623253160 City Jebabli Tajerouine
City Postal code Country Position/Affiliation
Tajerouine 7150 Tunisia PhD researcher in High Institute of Sport and Physical Education of Kef
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes As part of our commitment to transparency and scientific collaboration, we plan to share the individual trial participant data in an anonymized manner. In accordance with the World Health Organization's (WHO) data sharing policy, this IPD sharing statement aims to promote the replicability of study results and facilitate further analysis by the scientific community. The individual trial participant data collected for this study includes demographic information, medical history, treatment interventions, and clinical outcomes. All personally identifiable information has been rigorously removed or anonymized to protect the confidentiality of the participants. Only anonymous identification codes are used to link the data to individual participants. Statistical Analysis Plan,Study Protocol The IPD of this study are available from any demands open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 03/09/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 16/09/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information