UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050140 |
|---|---|
| Receipt number | R000057118 |
| Scientific Title | Development of a short-term exercise program specialized in improving children balance function for practical use in schools |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/04/08 14:34:04 |
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Basic information
Public title
Development of a short-term exercise program specialized in improving children balance function for practical use in schools
Acronym
Development of a short-term exercise program focused on improving balance function in children
Scientific Title
Development of a short-term exercise program specialized in improving children balance function for practical use in schools
Scientific Title:Acronym
Development of a short-term exercise program focused on improving balance function in children
Region
| Japan |
Condition
Condition
Healthy child
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is of great social significance because it aims to develop an exercise program to prevent and improve physical function decline due to inactivity brought on by the COVID-19 epidemic. In addition, this research is a groundbreaking approach toward a new approach of collaboration between academia and government, and we believe it is highly original. Specifically, we believe that the following three points can be achieved.
The study will identify children with impaired balance function by assessing their physical function in the athletic medical checkup.
Develop a short-term exercise program specialized for improving balance function, based on the data accumulated in the past.
Confirm the effectiveness of the developed exercise program in improving balance function, and put the program into practical use at collaborating schools.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to develop an effective short-term intervention program for the decline of children's balance function. If we can develop an exercise program to maintain or improve physical function and obtain the effect of the intervention, it will be possible to propose an exercise program to schools, local governments, and school boards for after COVID-19 convergence, which will lead to the prevention of physical function decline in children.
The results of this study will lead to the practical application in schools of exercise programs specifically designed to improve children's balance function for after COVID-19 convergence.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Physical function assessment: gait function, body composition measurement, muscle strength measurement, balance function assessment, agility assessment, postural alignment, activity level
2. Lifestyle assessment by questionnaire: physical activity time, sleep time, screen time, self-esteem
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
A 60-minute exercise program (with a 15-minute break) will be conducted at the applicant's medical institution for a period of three months (a total of 8 sessions on every Sunday:Include two reserve days to accommodate absences). The exercise program will include a dance program to the music produced, exercises using balance pads, ladders, and balance balls to improve balance function, and lower extremity strength training (squatting and jumping), based on previous studies (Huang SY. Am J Health Promot 2012; Anjos I. Rev Paul Pediatr 2018; Yanovich E. Children 2022), combined with 6-8 different programs.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | years-old | <= |
Age-upper limit
| 9 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Initiate locomotor physical examinations to identify children with impaired balance function.
Analyze the data of children who have participated in the locomotor physical checkups over the past 4 years and establish the reference values for balance function. For children whose balance function is judged to be lower than the standard value, distribute a survey form to those who wish to participate in a short-term exercise program specialized in balance function, and recruit participants.
Among the children who have participated in the physical exercise examination in the past (approximately 650 children as of September 2022), those whose balance function has been determined to be impaired will be contacted by their guardians to explain the exercise program, and consent for participation will be obtained from the children and their guardians if they wish to participate in the program.
Using G*Power (Heinrich Heine University, Germany), with effect size (d = 0.8), two-sided alpha value of 0.05, and power of 0.95, the optimal sample size for this study was confirmed to be 24 participants, therefore, considering a 30% dropout rate, 31 Participants will be recruited.
Key exclusion criteria
Orthopedic diseases, neuromuscular diseases
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Ito |
Organization
Aichi Prefectural Mikawa Aoitori Medical and Rehabilitation Center for Developmental Disabilities
Division name
Three-Dimensional Motion Analysis Laboratory
Zip code
444-0002
Address
9-3 Koyaba, Kouryuji-cho, Okazaki
TEL
0564-64-7980
tadashi.ito.0805@gmail.com
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Narahara |
Organization
Aichi Prefectural Mikawa Aoitori Medical and Rehabilitation Center for Developmental Disabilities
Division name
Department of Pediatrics
Zip code
444-0002
Address
9-3 Koyaba, Kouryuji-cho, Okazaki
TEL
0564-64-7980
Homepage URL
narahara@mikawa-aoitori.jp
Sponsor or person
Institute
Aichi Prefectural Mikawa Aoitori Medical and Rehabilitation Center for Developmental Disabilitie
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya University
Name of secondary funder(s)
Saitama Medical University
IRB Contact (For public release)
Organization
Aichi Prefectural Mikawa Aoitori Ethics Review Board
Address
9-3 Koyaba, Kouryuji-cho, Okazaki
Tel
0564-64-7980
sanjigen@mikawa-aoitori.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
愛知県三河青い鳥医療療育センター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
Results
There was a total of 24 participants over two months, (n=12 boys, n=12 girls). Significant differences in height were observed as they increased throughout the growth of the participants involved in this dance program. However, there were no significant differences in the weight and body mass index and body fat percentages among the participants. Grip strength, standing broad jump, and two-step test improved from before the program. There was no change in physical activity time and back muscle strength.
Results date posted
| 2023 | Year | 10 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 04 | Month | 08 | Day |
Baseline Characteristics
The dance was developed by a sports science permanent teacher, a professional dancer, and a physical therapist and evaluated in a community-based participatory study. In this program, trained dance instructors conducted one-hour dance sessions in a medical center. The sessions were held once a week for two months from June to August 2023. A physical therapist and a dance instructors led the elementary school children and assessed outcomes such as grip strength, lower extremity muscle strength, back muscle strength, balance function during movement, physical activity time, and adiposity. Descriptive statistics were used as the method of analysis.
Participant flow
Before initiating the development of the dance program, which was a collaborative effort between academic and medical institutions, children from Okazaki, Aichi Prefecture, underwent a medical examination and physical function evaluation before and during the COVID-19 epidemic to explore physical function that are likely to deteriorate. The study revealed a tendency for muscle strength and balance function to decline. The program was designed to be performed in a safe indoor environment and is free of charge for participants. Based on the research conducted by Schroeder et al., a dance program was developed with the involvement of dance instructors, sports instructors, physical therapists, and pediatricians as key advisors.
There were 36 total participants in the sample who applied to participate in this dance program. Data collected from the participants were evaluated before the start of the class and only once after the end of the class. Exclusion criteria included those with orthopedic, neurological, respiratory, or ophthalmologic problems; those with digestive disorders; and those who had more than 4 absences from the dance program, which could have affected the results of the physical function assessment and thus provided incomplete data. As a result, 12 of the 36 individuals were excluded, leaving 24 as the final sample used in this study.
Adverse events
Nothing in particular
Outcome measures
Grip strength
Standing broad jump
Back muscle strength
Two-Step Test
Physical Activity Time
Body Fat Percentage
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 26 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057118
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