Exercise TestNCT06393686
The Effect of Yoga on the Fitness of Children
A study testing yoga in people with Exercise Test and Physical Endurance, run by Near East University, Turkey at 1 site in Cyprus.
Trial summary
This study aims to evaluate the effect of yoga on physical fitness among healthy primary school children using a randomized control design. A total of 52 children, ages 8-13, will be randomly assigned to either the Yoga Group or the Control Group. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Test, Physical Endurance, Muscles
- What is being tested?
- yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Mar 2020to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants who do not have any mental or physical disabilities
- Participants who have not participated in any exercise regime for the previous six months
Who cannot join
- Individuals who do not participate in 90 percent of the 10-week yoga training program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Yoga Intervention on Physical Fitness Parameters in Preadolescent Children: A Randomized Controlled Trial
This study aims to evaluate the effect of yoga on physical fitness among healthy primary school children using a randomized control design. A total of 52 children, ages 8-13, will be randomly assigned to either the Yoga Group or the Control Group. Participants will be assessed using the EUROFIT Test Battery as the primary outcome measure.
The Yoga Group will do 45-minute yoga sessions twice a week for 10 weeks, while the Control Group will not receive any intervention. Outcome assessments will be repeated at the end of the 10-week intervention period.
Read the detailed description
This investigation is a randomized controlled trial designed to assess the physical fitness levels among primary school-age children subjected to diverse yoga interventions, comparing them with the outcomes observed in a control group devoid of such interventions.The study encompasses a 10-week intervention phase, during which participants undergo evaluation at two specific time points: Initial assessment (M1), conducted one week preceding the commencement of the exercise program, and subsequent evaluation (M2), executed one week post the conclusion of the program.Anthropometric measurements will determine the height of the participants using a non-elastic measuring tape (SECA brand) attached to the wall. Body Mass Index (BMI) will be calculated with the Tanita MC-180MA III device.The physical fitness of children will be measured with the Eurofit test battery.
- Conditions
- Exercise Test, Physical Endurance, Muscles
- Being tested
- yoga
- Keywords
- Yoga, Muscle Stretching Exercises, Physical Endurance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yogaOther
The yoga intervention will be implemented every two weeks, with each session lasting 45 minutes and implemented for 10 weeks. Sessions will always be led by the same certified yoga instructor. Each session will include a variety of different yoga poses, as well as breathing techniques and deep relaxation methods.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Group | Experimental | The yoga intervention will be implemented every two weeks, with each session lasting 45 minutes and implemented for 10 weeks. Sessions will always be led by the same certified yoga instructor. Each session will include a variety of different yoga poses, as well as breathing techniques and deep relaxation methods. Receives: Other: yoga |
| Control Group | No intervention | There will be no intervention in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
EUROFIT Test Battery
The 10 tests for the Eurofit Test Battery are used as standards in the measurements of school-aged children.
Anthropometry: Height, Weight, BMI, Skinfold thickness
- Flamingo balance test
- Arm movement speed
- Sit and reach
- Standing long jump
- Hand grip strength
- 30s Shuttle Bent arm hanging
- 10 x 5 meter shuttle run
- 20 m endurance (shuttle) run
Measured: 12 weeks
Anthropometric measurements
Anthropometric measurements involved determining participants' height using a non-elastic measuring tape (SECA brand), affixed to a wall. The Tanita MC-180MA III device facilitated weight analysis, and Body Mass Index (BMI) (kg/m2) was calculated by dividing body weight (in kilograms) by the square of height (in meters).
Measured: 12 weeks
Body Mass Index
Weight in kilograms and height in meters will been calculated and, weight and height will be combined to report BMI in kg/m2.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Mar 2020
- Primary completion1 Jun 2020
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TestStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RANDOMIZED CONTROLLED TRIAL
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melis Bagkur, Near East University, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393686
- Sponsor's protocol ID
- YDU/2019/74-938
- Status last verified
- May 2024
- First submitted
- 17 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Yoga Intervention on Physical Fitness Parameters in Preadolescent Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06393686
- Acronym / sponsor ID
- YDU/2019/74-938
- Conditions
- Exercise Test, Physical Endurance, Muscles
- Keywords
- Yoga, Muscle Stretching Exercises, Physical Endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 1 May 2024 (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.
This study aims to evaluate the effect of yoga on physical fitness among healthy primary school children using a randomized control design. A total of 52 children, ages 8-13, will be randomly assigned to either the Yoga Group or the Control Group. Participants will be assessed using the EUROFIT Test Battery as the primary outcome measure.
The Yoga Group will do 45-minute yoga sessions twice a week for 10 weeks, while the Control Group will not receive any intervention. Outcome assessments will be repeated at the end of the 10-week intervention period.
Detailed description
This investigation is a randomized controlled trial designed to assess the physical fitness levels among primary school-age children subjected to diverse yoga interventions, comparing them with the outcomes observed in a control group devoid of such interventions.The study encompasses a 10-week intervention phase, during which participants undergo evaluation at two specific time points: Initial assessment (M1), conducted one week preceding the commencement of the exercise program, and subsequent evaluation (M2), executed one week post the conclusion of the program.Anthropometric measurements will determine the height of the participants using a non-elastic measuring tape (SECA brand) attached to the wall. Body Mass Index (BMI) will be calculated with the Tanita MC-180MA III device.The physical fitness of children will be measured with the Eurofit test battery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RANDOMIZED CONTROLLED TRIAL
| Arm | Type | Receives |
|---|---|---|
| Yoga Group | Experimental | Other: yogaThe yoga intervention will be implemented every two weeks, with each session lasting 45 minutes and implemented for 10 weeks. Sessions will always be led by the same certified yoga instructor. Each session will include a variety of different yoga poses, as well as breathing techniques and deep relaxation methods. |
| Control Group | No intervention | –There will be no intervention in the control group. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Participants who do not have any mental or physical disabilities
- Participants who have not participated in any exercise regime for the previous six months
Key exclusion criteria (1 listed)
- Individuals who do not participate in 90 percent of the 10-week yoga training program.
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 |
|---|---|---|
| yogaThe yoga intervention will be implemented every two weeks, with each session lasting 45 minutes and implemented for 10 weeks. Sessions will always be led by the same certified yoga instructor. Each session will include a variety of different yoga poses, as well as breathing techniques and deep relaxation methods. | Other | Yoga Group |
Primary outcome
EUROFIT Test Battery
Time frame: 12 weeks
The 10 tests for the Eurofit Test Battery are used as standards in the measurements of school-aged children. Anthropometry: Height, Weight, BMI, Skinfold thickness * Flamingo balance test * Arm movement speed * Sit and reach * Standing long jump * Hand grip strength * 30s Shuttle Bent arm hanging * 10 x 5 meter shuttle run * 20 m endurance (shuttle) run
Anthropometric measurements
Time frame: 12 weeks
Anthropometric measurements involved determining participants' height using a non-elastic measuring tape (SECA brand), affixed to a wall. The Tanita MC-180MA III device facilitated weight analysis, and Body Mass Index (BMI) (kg/m2) was calculated by dividing body weight (in kilograms) by the square of height (in meters).
Body Mass Index
Time frame: 12 weeks
Weight in kilograms and height in meters will been calculated and, weight and height will be combined to report BMI in kg/m2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yoga in people with Exercise Test and Physical Endurance, run by Near East University, Turkey at 1 site in Cyprus.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 6 May 2024. 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 Cyprus. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EUROFIT Test Battery (time frame: 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?
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 6 May 2024.