- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04658563
Yoga for Adolescents
May 21, 2021 updated by: Neslihan Duruturk, Baskent University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey, 06790
- Başkent University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female adolescents between the ages of 14 and 18
Exclusion Criteria:
- Individuals with recent muscular skeletal, neuromuscular and chronic systemic diseases that could prevent exercise
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1: Yoga
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.
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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
Other Names:
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No Intervention: Group 2: Control
Individuals in the second group will not included in any exercise training program
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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8 weeks
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Assessment of Health-Related Physical Fitness - Lower extremity flexibility
Time Frame: 8 weeks
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Sit and Reach Test will be performed to assess lower extremity flexibility.
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8 weeks
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Assessment of Health-Related Physical Fitness - Balance
Time Frame: 8 weeks
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Time up-go test will be performed to evaluate the balance levels of the patients.
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8 weeks
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Assessment of Health-Related Physical Fitness - Endurance
Time Frame: 8 weeks
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Upper extremity muscular endurance will be evaluated by Sit-up Test and lower extremity muscular endurance by Sit up-down on Chair Test
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8 weeks
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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.
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8 weeks
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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.
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8 weeks
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Forced vital capacity (FVC)
Time Frame: 8 weeks
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Forced vital capacity (FVC) will be measured in Liter and %.
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8 weeks
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First-second forced expiratory volume (FEV1)
Time Frame: 8 weeks
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First-second forced expiratory volume (FEV1) will be measured in Liter and %.
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8 weeks
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Peak flow rate (PEF)
Time Frame: 8 weeks
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Peak flow rate (PEF) will be measured in Liter/second.
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8 weeks
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25-75% of forced expiratory flow rate (FEF (25-75%)
Time Frame: 8 weeks
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25-75% of forced expiratory flow rate will be measured in Liter.
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8 weeks
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Inspiratory capacity (IC)
Time Frame: 8 weeks
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Inspiratory capacity (IC) will be measured in Liter.
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8 weeks
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Vital capacity (VC)
Time Frame: 8 weeks
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Vital capacity (VC) will be measured in Liter.
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8 weeks
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Assessment of quality of life
Time Frame: 8 weeks
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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.
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8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Actual)
December 1, 2020
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
October 22, 2020
First Submitted That Met QC Criteria
December 7, 2020
First Posted (Actual)
December 8, 2020
Study Record Updates
Last Update Posted (Actual)
May 24, 2021
Last Update Submitted That Met QC Criteria
May 21, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- KA18 / 345
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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