YogaNCT04658563
Yoga for Adolescents
A study testing High Density Exercise Training Program - Yoga in people with Yoga, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: Specific effects of high-density Hatha Yoga(HY) training in adolescents have not yet been clarified. Aim of our study is to investigate the effects of high-density HY education on physical fitness, pulmonary function and quality of life in healthy adolescents. Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Yoga
- What is being tested?
- High Density Exercise Training Program - Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 1 Dec 2020
- 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 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female adolescents between the ages of 14 and 18
Who cannot join
- Individuals with recent muscular skeletal, neuromuscular and chronic systemic diseases that could prevent exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of High Density Hatha Yoga Training on Physical Fitness, Respiratory Functions and Quality of Life in Healthy Adolescents
Purpose: Specific effects of high-density Hatha Yoga(HY) training in adolescents have not yet been clarified. Aim of our study is to investigate the effects of high-density HY education on physical fitness, pulmonary function and quality of life in healthy adolescents. Methods: 28 female adolescents will be randomly divided into two groups as yoga training and control groups. Training group will receive high-density HY training for 8 weeks, two days a week under the supervision of a physiotherapist and one day a week home program. Control group will not receive any exercise. Flexibility of individuals will be determined by sit-reach, back scratching, lateral flexion tests; muscular endurance by sit-ups, sit down-stand up on chair tests, balance by time up-go test; cardiorespiratory capacity by incremental shuttle walking test(ISWT) and respiratory functions by spirometry, quality of life will be determined by with the Quality of Life Scale for Children.
- Conditions
- Yoga
- Being tested
- High Density Exercise Training Program - Yoga
- Keywords
- Yoga, physical fitness, adolescent, quality of life, sleep quality
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Density Exercise Training Program - YogaOther
Also called Yoga
A total of 8 weeks will be applied in our study, each session of the high-density yoga program will be started with 10 minute pranayama (breath) exercises as it is in classical yoga as a preliminary preparation for the participation of individuals; the program will be completed by applying 10-20 minutes warming-stretching movements, 40 minutes surya namaskar (SN) sets, 20-30 minutes dynamic yoga asanas and 10 minutes savasana. Participants will be encouraged to study the perceived difficulty levels between 14 and 17 using the Borg scale during the sessions
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Yoga | Experimental | High-density HY training; average 90-110 minutes, 2 sessions per week under the supervision of the physiotherapist, once a week as a home program, will be applied for a total of 8 weeks to the first group. Receives: Other: High Density Exercise Training Program - Yoga |
| Group 2: Control | No intervention | Individuals in the second group will not included in any exercise training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Health-Related Physical Fitness - Upper extremity flexibility
Lateral Flexion and Back Scratch Tests will be performed to evaluate upper extremity flexibility.
Measured: 8 weeks
Assessment of Health-Related Physical Fitness - Lower extremity flexibility
Sit and Reach Test will be performed to assess lower extremity flexibility.
Measured: 8 weeks
Assessment of Health-Related Physical Fitness - Balance
Time up-go test will be performed to evaluate the balance levels of the patients.
Measured: 8 weeks
Assessment of Health-Related Physical Fitness - Endurance
Upper extremity muscular endurance will be evaluated by Sit-up Test and lower extremity muscular endurance by Sit up-down on Chair Test
Measured: 8 weeks
Cardiorespiratory endurance
Incremental Shuttle Walking Test: The test is controlled by audible warnings between two marked points, 9 meters apart; individuals will be asked to walk at increasing speed with stimulus, and each meter they walk will be recorded as a shuttle.
Measured: 8 weeks
Assessment of Respiratory Functions
The pulmonary functions of the individuals will be evaluated in the sitting position using the portable spirometer device (COSMED, Micro Quark Spirometer, Rome, Italy) according to the ATS/ERS criteria. The individuals who participated in the study will be informed about the test before the test. The test will be repeated twice and the best results will be recorded. The individual is seated on a chair without a cuff, a latch is attached to his nose, his mouth is asked to be closed tightly so that the edges of the mouths could fully grasp the device. In respiratory function test, forced vital capacity (FVC) (Liter-L and %), first-second forced expiratory volume (FEV1)(L and %), FEV1/FVC, peak flow rate (PEF)(L/second), 25-75% of forced expiratory flow rate (FEF (25-75%)(L)), inspiratory capacity (IC) (L) and vital capasity (VC) (L) values will be recorded along with expected values and percentages by age, height, body weight and gender.
Measured: 8 weeks
Forced vital capacity (FVC)
Forced vital capacity (FVC) will be measured in Liter and %.
Measured: 8 weeks
First-second forced expiratory volume (FEV1)
First-second forced expiratory volume (FEV1) will be measured in Liter and %.
Measured: 8 weeks
Peak flow rate (PEF)
Peak flow rate (PEF) will be measured in Liter/second.
Measured: 8 weeks
25-75% of forced expiratory flow rate (FEF (25-75%)
25-75% of forced expiratory flow rate will be measured in Liter.
Measured: 8 weeks
Inspiratory capacity (IC)
Inspiratory capacity (IC) will be measured in Liter.
Measured: 8 weeks
Vital capacity (VC)
Vital capacity (VC) will be measured in Liter.
Measured: 8 weeks
Assessment of quality of life
The form which is prepared for adolescents aged 13-18 and validated and reliable in our country of The Pediatric Quality of Life Inventory. The 23 items of the scale developed for children aged 2-18 are scored between 0-100; the answers will be 100 if 'never' are preferred, 75 if 'rarely, 50 if 'sometimes, 25 if 'often, and 0 if 'always,. The higher the total score, the better the quality of life is.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Oct 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for YogaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Duruturk, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658563
- Sponsor's protocol ID
- KA18 / 345
- Status last verified
- May 2021
- First submitted
- 22 Oct 2020
- Last updated
- 24 May 2021
- 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 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Density Hatha Yoga Training on Physical Fitness, Respiratory Functions and Quality of Life in Healthy Adolescents
- ClinicalTrials.gov ID
- NCT04658563
- Acronym / sponsor ID
- KA18 / 345
- Conditions
- Yoga
- Keywords
- Yoga, physical fitness, adolescent, quality of life, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 8 Dec 2020 (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.
Purpose: Specific effects of high-density Hatha Yoga(HY) training in adolescents have not yet been clarified. Aim of our study is to investigate the effects of high-density HY education on physical fitness, pulmonary function and quality of life in healthy adolescents. Methods: 28 female adolescents will be randomly divided into two groups as yoga training and control groups. Training group will receive high-density HY training for 8 weeks, two days a week under the supervision of a physiotherapist and one day a week home program. Control group will not receive any exercise. Flexibility of individuals will be determined by sit-reach, back scratching, lateral flexion tests; muscular endurance by sit-ups, sit down-stand up on chair tests, balance by time up-go test; cardiorespiratory capacity by incremental shuttle walking test(ISWT) and respiratory functions by spirometry, quality of life will be determined by with the Quality of Life Scale for Children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Yoga | Experimental | Other: High Density Exercise Training Program - YogaHigh-density HY training; average 90-110 minutes, 2 sessions per week under the supervision of the physiotherapist, once a week as a home program, will be applied for a total of 8 weeks to the first group. |
| Group 2: Control | No intervention | –Individuals in the second group will not included in any exercise training program |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Female adolescents between the ages of 14 and 18
Key exclusion criteria (1 listed)
- Individuals with recent muscular skeletal, neuromuscular and chronic systemic diseases that could prevent exercise
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 |
|---|---|---|
| High Density Exercise Training Program - YogaAlso: YogaA total of 8 weeks will be applied in our study, each session of the high-density yoga program will be started with 10 minute pranayama (breath) exercises as it is in classical yoga as a preliminary preparation for the participation of individuals; the program will be completed by applying 10-20 minutes warming-stretching movements, 40 minutes surya namaskar (SN) sets, 20-30 minutes dynamic yoga asanas and 10 minutes savasana. Participants will be encouraged to study the perceived difficulty levels between 14 and 17 using the Borg scale during the sessions | Other | Group 1: Yoga |
Primary outcome
Assessment of Health-Related Physical Fitness - Upper extremity flexibility
Time frame: 8 weeks
Lateral Flexion and Back Scratch Tests will be performed to evaluate upper extremity flexibility.
Assessment of Health-Related Physical Fitness - Lower extremity flexibility
Time frame: 8 weeks
Sit and Reach Test will be performed to assess lower extremity flexibility.
Assessment of Health-Related Physical Fitness - Balance
Time frame: 8 weeks
Time up-go test will be performed to evaluate the balance levels of the patients.
Assessment of Health-Related Physical Fitness - Endurance
Time frame: 8 weeks
Upper extremity muscular endurance will be evaluated by Sit-up Test and lower extremity muscular endurance by Sit up-down on Chair Test
Cardiorespiratory endurance
Time frame: 8 weeks
Incremental Shuttle Walking Test: The test is controlled by audible warnings between two marked points, 9 meters apart; individuals will be asked to walk at increasing speed with stimulus, and each meter they walk will be recorded as a shuttle.
Assessment of Respiratory Functions
Time frame: 8 weeks
The pulmonary functions of the individuals will be evaluated in the sitting position using the portable spirometer device (COSMED, Micro Quark Spirometer, Rome, Italy) according to the ATS/ERS criteria. The individuals who participated in the study will be informed about the test before the test. The test will be repeated twice and the best results will be recorded. The individual is seated on a chair without a cuff, a latch is attached to his nose, his mouth is asked to be closed tightly so that the edges of the mouths could fully grasp the device. In respiratory function test, forced vital capacity (FVC) (Liter-L and %), first-second forced expiratory volume (FEV1)(L and %), FEV1/FVC, peak flow rate (PEF)(L/second), 25-75% of forced expiratory flow rate (FEF (25-75%)(L)), inspiratory capacity (IC) (L) and vital capasity (VC) (L) values will be recorded along with expected values and percentages by age, height, body weight and gender.
Forced vital capacity (FVC)
Time frame: 8 weeks
Forced vital capacity (FVC) will be measured in Liter and %.
First-second forced expiratory volume (FEV1)
Time frame: 8 weeks
First-second forced expiratory volume (FEV1) will be measured in Liter and %.
Peak flow rate (PEF)
Time frame: 8 weeks
Peak flow rate (PEF) will be measured in Liter/second.
25-75% of forced expiratory flow rate (FEF (25-75%)
Time frame: 8 weeks
25-75% of forced expiratory flow rate will be measured in Liter.
Inspiratory capacity (IC)
Time frame: 8 weeks
Inspiratory capacity (IC) will be measured in Liter.
Vital capacity (VC)
Time frame: 8 weeks
Vital capacity (VC) will be measured in Liter.
Assessment of quality of life
Time frame: 8 weeks
The form which is prepared for adolescents aged 13-18 and validated and reliable in our country of The Pediatric Quality of Life Inventory. The 23 items of the scale developed for children aged 2-18 are scored between 0-100; the answers will be 100 if 'never' are preferred, 75 if 'rarely, 50 if 'sometimes, 25 if 'often, and 0 if 'always,. The higher the total score, the better the quality of life is.
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 24 May 2021.
- 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 High Density Exercise Training Program - Yoga in people with Yoga, run by Baskent University at 1 site in Turkey (Türkiye).
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 1 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 24 May 2021. 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 Turkey (Türkiye). 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?
Assessment of Health-Related Physical Fitness - Upper extremity flexibility (time frame: 8 weeks). The study lists 13 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 24 May 2021.