- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07597720
Strengthening Children's Coordination and Balance in Everyday Life (KiKoBal)
Effects of a School-based Balance Training Program on Motor Proficiency in Children Aged 6 to 11 Years: A Randomized Controlled Trial
The World Health Organization recommends that children and teenagers aged 5 to 17 should be physically active for at least 60 minutes every day. This should include activities that make them breathe harder, as well as exercises that strengthen muscles and bones. National guidelines in Austria and Germany also highlight the importance of basic movement skills such as endurance, strength, coordination, and balance.
Regular physical activity is important for children's physical and mental health. It can help prevent problems such as obesity, diabetes, and heart disease. It can also support learning, concentration, and school performance. However, many children do not move enough. In Austria and Germany, only a small number of children and teenagers meet the recommended activity levels.
Because of this, many programs have been created to encourage children to be more active, for example through active breaks, park activities, or sports clubs. These programs often include simple movement games, warm-up exercises, and strengthening exercises such as squats. Balance and coordination exercises are used less often. Also, many programs mainly count how many children take part, but they do not always measure how the programs improve children's movement skills.
This study therefore looks at whether targeted balance and coordination training improves the motor skills of children aged 6 to 11 in school sports. It will compare this training with strength training. Over four weeks, children will take part in one of the two training programs. Their motor skills, such as coordination, strength, flexibility, and endurance, will be tested before and after the program. The study will also look at how the children's general physical activity level influences their motor development.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
According to the World Health Organization (WHO), physical activity plays a central role in promoting the health of children and adolescents. It recommends at least 60 minutes of daily physical activity at a moderate to vigorous intensity for 5- to 17-year-olds. In addition, muscle- and bone-strengthening exercises should be performed weekly. These recommendations are also reflected in national guidelines-such as the Austrian HBSC fact sheets or the German inventory on physical activity promotion, which further specify the WHO guidelines and focus on basic motor skills such as endurance, strength, and coordination.
A comprehensive Cochrane review demonstrates the positive effects of physical activity on physical and mental health in childhood and adolescence. Physical activity can not only reduce the risk of chronic diseases such as obesity, diabetes, or cardiovascular problems, but also positively influence cognitive development and academic performance.
Despite this knowledge, physical inactivity is widespread among young people: In Austria, according to the 2018 HBSC study, only 20% of 11- to 15-year-olds meet the recommended daily physical activity guidelines-a downward trend. In Germany, data from the Motor Skills Module (MoMo) show that only 15.3% of children and adolescents between the ages of 4 and 17 meet the physical activity recommendations.
Against this backdrop, numerous health promotion programs have been launched. These range from "Active Recess" and "Active in the Park" to sports club-based training concepts. Initial findings, such as those from the MoMo study or the work of Doose et al. 2021, point to a stabilization of activity levels. The problem with many of these programs, however, is that while participation is recorded as an important outcome, there is no data on the specific impact on motor developmen.
The programs mainly include exercises for general mobilization and loosening up (e.g., shoulder circles) as well as various strengthening exercises (e.g., squats), mostly in the form of games. Coordination and balance exercises (e.g., standing on one leg) as well as exercises to improve flexibility (e.g., yoga exercises) are used less frequently.
Based on this fact, the question arises as to what effect targeted coordination/balance training has on the motor performance of children and adolescents aged 6 to 11 years in the context of school sports, compared to strength training. Furthermore, the influence of physical activity levels on the development of motor performance will be investigated.
As part of an extramural prospective 2-arm study, the differences between an additional 4-week balance/coordination training program versus strength training within the context of school physical education on motor skills (measured using the Bruininks-Oseretzky Test Version 2, Jamar Hand Dynamometer, Sit and Reach, and 6-minute endurance run) of students aged 6 to 11, and the influence of physical activity levels (MoMo Questionnaire for Physical Activity) will be analyzed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Upper Austria
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Linz, Upper Austria, Austria, 4020
- University of Applied Sciences for Health Professions Upper Austria
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- primary school children aged 6 to 11 years
Exclusion Criteria:
- Official exemption from physical education in school
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Balance Training Group
|
The balance exercise program is conducted over a four-week period and consists of two training sessions per week. Each session lasts about 30 to 35 minutes. During each session, various balance exercises are performed, with each exercise consisting of two sets of 30 seconds each. There is a 60-second rest between sets and a 90-second rest between individual exercises. The intensity of the training is adjusted by progressively increasing the level of difficulty. Initially, the exercises are performed with support and under simpler conditions, while additional challenges-such as closing the eyes, omitting arm support, or performing additional cognitive tasks-are integrated as the program progresses. The training method consists of functional balance training with static and dynamic exercises on stable and unstable surfaces (e.g., exercise mat, balance board, or balance beam). The strength training program is conducted over a period of four weeks and includes two training sessions per week. Each session lasts about 30 to 35 minutes and includes six to eight exercises. These are performed in two sets with a variable number of repetitions, with breaks of one to two minutes between exercises. The intensity of the training is controlled by the number of repetitions and the subjective exertion, which should not exceed a value of 6 on a scale of 1 to 10. The exercises are performed at a slow to moderate speed to ensure controlled execution. The program consists of functional strength exercises using one's own body weight as well as simple training equipment (e.g., medicine ball or exercise ball). It primarily incorporates coordinative and stabilizing movement patterns designed to be child-friendly (e.g., crawling movements, holding exercises, or dynamic whole-body exercises). |
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Active Comparator: Strength Training Group
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The balance exercise program is conducted over a four-week period and consists of two training sessions per week. Each session lasts about 30 to 35 minutes. During each session, various balance exercises are performed, with each exercise consisting of two sets of 30 seconds each. There is a 60-second rest between sets and a 90-second rest between individual exercises. The intensity of the training is adjusted by progressively increasing the level of difficulty. Initially, the exercises are performed with support and under simpler conditions, while additional challenges-such as closing the eyes, omitting arm support, or performing additional cognitive tasks-are integrated as the program progresses. The training method consists of functional balance training with static and dynamic exercises on stable and unstable surfaces (e.g., exercise mat, balance board, or balance beam). The strength training program is conducted over a period of four weeks and includes two training sessions per week. Each session lasts about 30 to 35 minutes and includes six to eight exercises. These are performed in two sets with a variable number of repetitions, with breaks of one to two minutes between exercises. The intensity of the training is controlled by the number of repetitions and the subjective exertion, which should not exceed a value of 6 on a scale of 1 to 10. The exercises are performed at a slow to moderate speed to ensure controlled execution. The program consists of functional strength exercises using one's own body weight as well as simple training equipment (e.g., medicine ball or exercise ball). It primarily incorporates coordinative and stabilizing movement patterns designed to be child-friendly (e.g., crawling movements, holding exercises, or dynamic whole-body exercises). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Bruininks-Oseretsky Motor Proficiency Test 2nd Edition german version
Time Frame: At baseline and day 77
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Bruininks-Oseretsky Test of Motor Proficiency, 2nd Edition is standardized for children and adolescents aged 4 to 21 years and 11 months, and the full test takes 45 to 60 minutes to perform.
The BOT-2 is used to detect deviations from the norm and to support the assessment of motor impairments, including the likelihood of a diagnosis for DCD.
It measures fine and gross motor proficiency, with subtests focusing on stability, mobility, strength, coordination, and object manipulation.
Results can be reported as raw scores, scale scores, composite scores, percentile ranks, or standard scores.
The minimum and maximum values depend on the specific subtest or composite score used.
For standard scores, higher values indicate a better result, as they reflect stronger motor proficiency compared with age-based norms.
Lower values indicate greater deviation from the norm and poorer motor performance.
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At baseline and day 77
|
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Handgrip strength
Time Frame: At baseline and day 77
|
The Jamar Hand Dynamometer is a standardized instrument used to measure hand grip strength in children, adolescents, and adults.
It is commonly used in clinical practice and research to assess upper limb strength, functional hand performance, and changes in muscle strength over time.
The test is typically performed within a few minutes and involves the participant squeezing the dynamometer with maximal effort, usually across repeated trials for each hand.
The result is recorded in kilograms or pounds of force.
The minimum value is 0 kg/lb, if no grip force is produced.
The maximum value depends on the measuring range of the specific dynamometer model, commonly up to about 90 kg or 200 lb.
Higher values indicate a better result, as they reflect greater isometric hand grip strength and upper limb muscle function.
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At baseline and day 77
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Flexibility
Time Frame: At baseline and day 77
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The Sit and Reach Test is a standardised test used to assess flexibility, particularly that of the lower back and hamstring muscles.
It is commonly used with children, adolescents and adults in clinical, educational and research settings.
The test is quick to administer and usually takes only a few minutes to perform.
During the test, the participant sits with their legs extended and reaches forward as far as possible towards or beyond their toes.
The distance reached is then measured using a sit-and-reach box or measuring scale.
The result is recorded in centimetres.
Depending on the test setup, values may be positive when the participant reaches beyond the toes and negative when they do not reach the toes.
Therefore, there is no fixed universal minimum or maximum value, as the range depends on the measuring scale and individual performance.
Higher values indicate greater flexibility of the lower back and hamstring muscles, and therefore a better result.
|
At baseline and day 77
|
|
Aerobic endurance
Time Frame: At baseline and day 77
|
The 6-Minute Walk/Run Test is a standardised field test used to evaluate the aerobic endurance and cardiorespiratory fitness of children, adolescents and adults.
The test takes six minutes to complete.
During the test, participants are instructed to walk or run as far as possible on a marked track or defined course within six minutes.
The total distance covered is recorded in metres and can be compared with age- and sex-specific reference values.
The minimum value is 0 metres if no distance is covered.
There is no fixed maximum value as this depends on the individual's performance and the distance they complete within six minutes.
Higher values indicate a better result as they reflect greater aerobic endurance, cardiorespiratory fitness and functional exercise capacity.
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At baseline and day 77
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported level of physical activity
Time Frame: At baseline
|
The MoMo Questionnaire for Students is a standardised self-report tool used to evaluate the physical activity and sports-related behaviour of children and adolescents.
It records activity in various contexts, including everyday life, school, leisure time and sports clubs, and considers frequency, duration and intensity.
Outcome variables can include activity days per week, minutes per week and metabolic equivalent of task (MET) minutes per week.
MET-minutes per week are calculated as follows: MET-min/week = days/week × minutes/day × MET value.
The minimum value is 0 MET-min/week, while the maximum depends on the reported duration and assigned intensity.
Higher values indicate a better result as they reflect a greater amount and/or intensity of physical activity.
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At baseline
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Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Chaput JP, Willumsen J, Bull F, Chou R, Ekelund U, Firth J, Jago R, Ortega FB, Katzmarzyk PT. 2020 WHO guidelines on physical activity and sedentary behaviour for children and adolescents aged 5-17 years: summary of the evidence. Int J Behav Nutr Phys Act. 2020 Nov 26;17(1):141. doi: 10.1186/s12966-020-01037-z.
- Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.
- World Health Organization. (2022). Primary health care for children and adolescents: A framework for ac-tion.
- Woll A, Kurth BM, Opper E, Worth A, Bos K. The 'Motorik-Modul' (MoMo): physical fitness and physical activity in German children and adolescents. Eur J Pediatr. 2011 Sep;170(9):1129-42. doi: 10.1007/s00431-010-1391-4. Epub 2011 Feb 12.
- Woll A, Klos L, Burchartz A, Hanssen-Doose A, Niessner C, Oriwol D, Schmidt SCE, Bos K, Worth A. Cohort Profile Update: The Motorik-Modul (MoMo) Longitudinal Study-physical fitness and physical activity as determinants of health development in German children and adolescents. Int J Epidemiol. 2021 May 17;50(2):393-394. doi: 10.1093/ije/dyaa281. No abstract available.
- Sportunion Österreich. (2007). UGOTCHI - Kinder gesund bewegen. https://ugotchi.at/
- Pfeifer K, Rutten A. [National Recommendations for Physical Activity and Physical Activity Promotion]. Gesundheitswesen. 2017 Mar;79(S 01):S2-S3. doi: 10.1055/s-0042-123346. Epub 2017 Apr 11. No abstract available. German.
- Paulus, P. (Hrsg.). (2016). Bildungsförderung durch Gesundheit: Bestandsaufnahme und Perspektiven für eine gute gesunde Schule (Dr. nach Typoskript). Juventa-Verl.
- Mlinek, T. (2025, August 11). Die Tägliche Bewegungseinheit. tbe Kindergarten Volkschule Sekundasstufe I. https://www.bewegungseinheit.gv.at/volksschule/bewegte-schule
- Hanssen-Doose, A., Oriwol, D., Niessner, C., Schmidt, S. C. E., Klemm, K., Woll, A., & Worth, A. (2021). Dauerhaftes Sporttreiben im Sportverein und motorische Entwicklung: Ergebnisse der MoMo-Längsschnitt-studie (2003-2017). Forum Kinder- und Jugendsport, 2(2), 122-130. https://doi.org/10.1007/s43594-021-00054-5
- Förderverein Nachwuchsleistungssport Tirol. (2025, August 11). MEIN KIND IM SPORT. https://www.mein-kindimsport.at/ueberblick
- Bundesministerium für Soziales, Gesundheit, Pflege und Konsumentenschutz. (2020, September 1). Das Be-wegungsverhalten österreichischer Schülerinnen und Schüler HBSC-Factsheet 05: Ergebnisse der HBSC-Studie 2018.
- Barbosa A, Whiting S, Simmonds P, Scotini Moreno R, Mendes R, Breda J. Physical Activity and Academic Achievement: An Umbrella Review. Int J Environ Res Public Health. 2020 Aug 17;17(16):5972. doi: 10.3390/ijerph17165972.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-2026-041
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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