Normal PopulationNCT06893692
Otago Exercise Program on Balance, Endurance and Motor Coordination in Pre-school Children
A study testing Otago exercise program and Balance Training Exercises in people with Normal Population, run by Riphah International University at 1 site in Pakistan.
Trial summary
Balance training is crucial for preschool children's motor development and physical health. Engaging in endurance training enhances their aerobic capacity and fitness, leading to better health and the ability to sustain activities without fatigue. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Population
- What is being tested?
- Otago exercise program and Balance Training Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Both Genders.
- 3-6 years age
- Guardian's informed consent and, children were able to collaborate and engage throughout the intervention.
- Flamingo test score between 15-30 seconds.
Who cannot join
- Associated orthopedics conditions.
- Underlying genetic disorders
- Developmental Delay
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Muhammad Asif Javed
Lahore, Punjab Province, 54900
Muhammad Asif Javed, MS-P(Neuro), 923224209422, a.javed@riphah.edu.pk
About this study
Official title: Effect of Otage Exercise Program on Balance, Endurance and Motor Coordination in Pre-school Children.
Balance training is crucial for preschool children's motor development and physical health. Engaging in endurance training enhances their aerobic capacity and fitness, leading to better health and the ability to sustain activities without fatigue. Early endurance development fosters lifelong physical activity habits, preventing childhood obesity and related health issues. Incorporating playful elements makes exercises engaging and age-appropriate. Regular balance training improves dynamic balance, essential for running, jumping, and sports, while reducing the risk of falls and injuries. Motor coordination training, combining balance and endurance, improves complex movement skills and spatial awareness. Adapting the Otago Exercise Program for young children addresses gaps in physical activity interventions, combating inactivity and obesity. This program aims to establish a foundation for lifelong physical activity and health by improving balance, endurance, and motor coordination.
The current study will be randomized control trial; data will be collected from Pre-school of Lahore. The sample size will be 30. Non-probability convenient sampling technique will be used. Inclusion criteria for the study will be both genders, 3-6 years age children and Guardians' informed consent and children were able to collaborate and engage throughout that intervention. Participants with associated orthopedics conditions, underlying genetic disorders and developmental delay will be excluded from the study. One experimental group will perform Otago Exercise Program (Warm-up Exercises and Strengthening Exercises) along balance Training Exercises and the other control group will perform Balance Training exercises (Single-leg stance with eyes open and closed, Standing on heels and toes, Tandem and semi tandem foot stance, Tandem walking, Walking backward and forward and Weight Shifting) Outcomes to be analyzed will be balance, endurance and motor coordination. For 12 weeks, participants in the study will undergo three sessions per week, lasting 40-45 minutes each. Tools used for data collection will be Four-stage balance test, 30 Second chair stand test and Time up and down stairs test, Balance beam test. Data will be analyzed through SPSS version 23.00.
Read the detailed description
Balance training is crucial for preschool children's motor development and physical health. Engaging in endurance training enhances their aerobic capacity and fitness, leading to better health and the ability to sustain activities without fatigue. Early endurance development fosters lifelong physical activity habits, preventing childhood obesity and related health issues. Incorporating playful elements makes exercises engaging and age-appropriate. Regular balance training improves dynamic balance, essential for running, jumping, and sports, while reducing the risk of falls and injuries. Motor coordination training, combining balance and endurance, improves complex movement skills and spatial awareness. Adapting the Otago Exercise Program for young children addresses gaps in physical activity interventions, combating inactivity and obesity. This program aims to establish a foundation for lifelong physical activity and health by improving balance, endurance, and motor coordination.
The current study will be randomized control trial; data will be collected from Pre-school of Lahore. The sample size will be 30. Non-probability convenient sampling technique will be used. Inclusion criteria for the study will be both genders, 3-6 years age children and Guardians' informed consent and children were able to collaborate and engage throughout that intervention. Participants with associated orthopedics conditions, underlying genetic disorders and developmental delay will be excluded from the study. One experimental group will perform Otago Exercise Program (Warm-up Exercises and Strengthening Exercises) along balance Training Exercises and the other control group will perform Balance Training exercises (Single-leg stance with eyes open and closed, Standing on heels and toes, Tandem and semi tandem foot stance, Tandem walking, Walking backward and forward and Weight Shifting) Outcomes to be analyzed will be balance, endurance and motor coordination. For 12 weeks, participants in the study will undergo three sessions per week, lasting 40-45 minutes each. Tools used for data collection will be Four-stage balance test, 30 Second chair stand test and Time up and down stairs test, Balance beam test. Data will be analyzed through SPSS version 23.00
- Conditions
- Normal Population
- Being tested
- Otago exercise program, Balance Training Exercises
- Keywords
- Otago Exercise Program, Pre-School Children, Balance, Endurance, Motor Coordination, Physical Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago exercise programOther
Experimental group: Group A will perform the Otago Exercise Program. The training protocol consisted of ten repetitions, with a 60-second rest interval between sets. The training protocol consisted of three sessions per week for 12 weeks.
Balance Training ExercisesOther
Controlled group: Group B will perform Balance Training Exercises for 12 weeks of three sessions per week. BT included exercises such as a single-leg stance with eyes open and closed, standing on heels or toes, tandem and semi-tandem foot stance, tandem walking, walking backward and forward, and weight shifting.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Group A will perform the Otago Exercise Program. The training protocol consisted of ten repetitions, with a 60-second rest interval between sets. The training protocol consisted of three sessions per week for 12 weeks. Receives: Other: Otago exercise program |
| Controlled group | Active comparator | Group B will perform Balance Training Exercises for 12 weeks of three sessions per week. BT included exercises such as a single-leg stance with eyes open and closed, standing on heels or toes, tandem and semi-tandem foot stance, tandem walking, walking backward and forward, and weight shifting. Receives: Other: Balance Training Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
The Beam Balance Test is an effective assessment for measuring balance and stability, especially in children and older adults. Participants stand on a slightly elevated narrow beam, typically made of wood or metal, and attempt to maintain balance for 30 seconds to 1 minute. This test helps identify balance skills and potential issues.
Measured: Baseline, 3 weeks, 6 weeks, 9 weeks and 12 weeks.
Endurance
The purpose of this test is to assess leg strength and endurance. The equipment needed includes a chair with a straight back without arm rests and a stopwatch. During the test, the participant sits in a chair with arms crossed over the chest and feet flat on the floor.
Measured: Baseline, 3 weeks, 6 weeks, 9 weeks and 12 weeks.
Coordination
The Time Up and Down Stairs Test measures cardiovascular endurance and mobility by timing how quickly an individual can ascend and descend a set of stairs.
Measured: Baseline, 3 weeks, 6 weeks, 9 weeks and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start15 Mar 2025
- Primary completion8 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Normal PopulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The current study will be randomized control trial, data will be collected from Pre-school of Lahore. Sample size will be 30. Inclusion criteria for the study will be both genders, 3-6 years age children and Guardians' informed consent and children were able to collaborate and engage throughout that intervention. Participants with associated orthopedics conditions, underlying genetic disorders and developmental delay will be excluded from the study. One experimental group will perform Otago Exercise Program along balance Training Exercises and the other control group will perform Balance Training exercises.Outcomes to be analyzed will be balance, endurance and motor coordination. For 12 weeks, participants in the study will undergo three sessions per week, lasting 40-45 minutes each. Tools used: Four-stage balance test, 30 Second chair stand test and Time up and down stairs test, Balance beam test.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tooba Kaukab, MS-PPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893692
- Sponsor's protocol ID
- REC/RCR/AHS/25/Tooba Kaukab
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hammami R, Aliani L, Gargallo P, Rebai H, Gene-Morales J, Colado JC. The effects of three types of balance training programs on measures of balance and muscle power in prepubertal children: A randomized controlled trial. J Sci Med Sport. 2023 Oct 16:S1440-2440(23)00425-5. doi: 10.1016/j.jsams.2023.10.004. Online ahead of print.
PubMed 39492052
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Otage Exercise Program on Balance, Endurance and Motor Coordination in Pre-school Children.
- ClinicalTrials.gov ID
- NCT06893692
- Acronym / sponsor ID
- REC/RCR/AHS/25/Tooba Kaukab
- Conditions
- Normal Population
- Keywords
- Otago Exercise Program, Pre-School Children, Balance, Endurance, Motor Coordination, Physical Development
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 8 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Balance training is crucial for preschool children's motor development and physical health. Engaging in endurance training enhances their aerobic capacity and fitness, leading to better health and the ability to sustain activities without fatigue. Early endurance development fosters lifelong physical activity habits, preventing childhood obesity and related health issues. Incorporating playful elements makes exercises engaging and age-appropriate. Regular balance training improves dynamic balance, essential for running, jumping, and sports, while reducing the risk of falls and injuries. Motor coordination training, combining balance and endurance, improves complex movement skills and spatial awareness. Adapting the Otago Exercise Program for young children addresses gaps in physical activity interventions, combating inactivity and obesity. This program aims to establish a foundation for lifelong physical activity and health by improving balance, endurance, and motor coordination.
The current study will be randomized control trial; data will be collected from Pre-school of Lahore. The sample size will be 30. Non-probability convenient sampling technique will be used. Inclusion criteria for the study will be both genders, 3-6 years age children and Guardians' informed consent and children were able to collaborate and engage throughout that intervention. Participants with associated orthopedics conditions, underlying genetic disorders and developmental delay will be excluded from the study. One experimental group will perform Otago Exercise Program (Warm-up Exercises and Strengthening Exercises) along balance Training Exercises and the other control group will perform Balance Training exercises (Single-leg stance with eyes open and closed, Standing on heels and toes, Tandem and semi tandem foot stance, Tandem walking, Walking backward and forward and Weight Shifting) Outcomes to be analyzed will be balance, endurance and motor coordination. For 12 weeks, participants in the study will undergo three sessions per week, lasting 40-45 minutes each. Tools used for data collection will be Four-stage balance test, 30 Second chair stand test and Time up and down stairs test, Balance beam test. Data will be analyzed through SPSS version 23.00.
Detailed description
Balance training is crucial for preschool children's motor development and physical health. Engaging in endurance training enhances their aerobic capacity and fitness, leading to better health and the ability to sustain activities without fatigue. Early endurance development fosters lifelong physical activity habits, preventing childhood obesity and related health issues. Incorporating playful elements makes exercises engaging and age-appropriate. Regular balance training improves dynamic balance, essential for running, jumping, and sports, while reducing the risk of falls and injuries. Motor coordination training, combining balance and endurance, improves complex movement skills and spatial awareness. Adapting the Otago Exercise Program for young children addresses gaps in physical activity interventions, combating inactivity and obesity. This program aims to establish a foundation for lifelong physical activity and health by improving balance, endurance, and motor coordination.
The current study will be randomized control trial; data will be collected from Pre-school of Lahore. The sample size will be 30. Non-probability convenient sampling technique will be used. Inclusion criteria for the study will be both genders, 3-6 years age children and Guardians' informed consent and children were able to collaborate and engage throughout that intervention. Participants with associated orthopedics conditions, underlying genetic disorders and developmental delay will be excluded from the study. One experimental group will perform Otago Exercise Program (Warm-up Exercises and Strengthening Exercises) along balance Training Exercises and the other control group will perform Balance Training exercises (Single-leg stance with eyes open and closed, Standing on heels and toes, Tandem and semi tandem foot stance, Tandem walking, Walking backward and forward and Weight Shifting) Outcomes to be analyzed will be balance, endurance and motor coordination. For 12 weeks, participants in the study will undergo three sessions per week, lasting 40-45 minutes each. Tools used for data collection will be Four-stage balance test, 30 Second chair stand test and Time up and down stairs test, Balance beam test. Data will be analyzed through SPSS version 23.00
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The current study will be randomized control trial, data will be collected from Pre-school of Lahore. Sample size will be 30. Inclusion criteria for the study will be both genders, 3-6 years age children and Guardians' informed consent and children were able to collaborate and engage throughout that intervention. Participants with associated orthopedics conditions, underlying genetic disorders and developmental delay will be excluded from the study. One experimental group will perform Otago Exercise Program along balance Training Exercises and the other control group will perform Balance Training exercises.Outcomes to be analyzed will be balance, endurance and motor coordination. For 12 weeks, participants in the study will undergo three sessions per week, lasting 40-45 minutes each. Tools used: Four-stage balance test, 30 Second chair stand test and Time up and down stairs test, Balance beam test.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Otago exercise programGroup A will perform the Otago Exercise Program. The training protocol consisted of ten repetitions, with a 60-second rest interval between sets. The training protocol consisted of three sessions per week for 12 weeks. |
| Controlled group | Active comparator | Other: Balance Training ExercisesGroup B will perform Balance Training Exercises for 12 weeks of three sessions per week. BT included exercises such as a single-leg stance with eyes open and closed, standing on heels or toes, tandem and semi-tandem foot stance, tandem walking, walking backward and forward, and weight shifting. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Both Genders.
- 3-6 years age
- Guardian's informed consent and, children were able to collaborate and engage throughout the intervention.
- Flamingo test score between 15-30 seconds.
Key exclusion criteria (3 listed)
- Associated orthopedics conditions.
- Underlying genetic disorders
- Developmental Delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Otago exercise programExperimental group: Group A will perform the Otago Exercise Program. The training protocol consisted of ten repetitions, with a 60-second rest interval between sets. The training protocol consisted of three sessions per week for 12 weeks. | Other | Experimental group |
| Balance Training ExercisesControlled group: Group B will perform Balance Training Exercises for 12 weeks of three sessions per week. BT included exercises such as a single-leg stance with eyes open and closed, standing on heels or toes, tandem and semi-tandem foot stance, tandem walking, walking backward and forward, and weight shifting. | Other | Controlled group |
Primary outcome
Balance
Time frame: Baseline, 3 weeks, 6 weeks, 9 weeks and 12 weeks.
The Beam Balance Test is an effective assessment for measuring balance and stability, especially in children and older adults. Participants stand on a slightly elevated narrow beam, typically made of wood or metal, and attempt to maintain balance for 30 seconds to 1 minute. This test helps identify balance skills and potential issues.
Endurance
Time frame: Baseline, 3 weeks, 6 weeks, 9 weeks and 12 weeks.
The purpose of this test is to assess leg strength and endurance. The equipment needed includes a chair with a straight back without arm rests and a stopwatch. During the test, the participant sits in a chair with arms crossed over the chest and feet flat on the floor.
Coordination
Time frame: Baseline, 3 weeks, 6 weeks, 9 weeks and 12 weeks.
The Time Up and Down Stairs Test measures cardiovascular endurance and mobility by timing how quickly an individual can ascend and descend a set of stairs.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Background: PubMed 39492052Hammami R, Aliani L, Gargallo P, Rebai H, Gene-Morales J, Colado JC. The effects of three types of balance training programs on measures of balance and muscle power in prepubertal children: A randomized controlled trial. J Sci Med Sport. 2023 Oct 16:S1440-2440(23)00425-5. doi: 10.1016/j.jsams.2023.10.004. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tooba Kaukab, MS-PPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otago exercise program and Balance Training Exercises in people with Normal Population, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IMRAN AMJAD, PhD (9233224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: Baseline, 3 weeks, 6 weeks, 9 weeks and 12 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06893692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.