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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04658563
Other study ID # KA18 / 345
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date December 1, 2020

Study information

Verified date May 2021
Source Baskent University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date December 1, 2020
Est. primary completion date December 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
High Density Exercise Training Program - 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

Locations

Country Name City State
Turkey Baskent University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of Health-Related Physical Fitness - Upper extremity flexibility Lateral Flexion and Back Scratch Tests will be performed to evaluate upper extremity flexibility. 8 weeks
Primary Assessment of Health-Related Physical Fitness - Lower extremity flexibility Sit and Reach Test will be performed to assess lower extremity flexibility. 8 weeks
Primary Assessment of Health-Related Physical Fitness - Balance Time up-go test will be performed to evaluate the balance levels of the patients. 8 weeks
Primary 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 8 weeks
Primary 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. 8 weeks
Primary 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. 8 weeks
Primary Forced vital capacity (FVC) Forced vital capacity (FVC) will be measured in Liter and %. 8 weeks
Primary First-second forced expiratory volume (FEV1) First-second forced expiratory volume (FEV1) will be measured in Liter and %. 8 weeks
Primary Peak flow rate (PEF) Peak flow rate (PEF) will be measured in Liter/second. 8 weeks
Primary 25-75% of forced expiratory flow rate (FEF (25-75%) 25-75% of forced expiratory flow rate will be measured in Liter. 8 weeks
Primary Inspiratory capacity (IC) Inspiratory capacity (IC) will be measured in Liter. 8 weeks
Primary Vital capacity (VC) Vital capacity (VC) will be measured in Liter. 8 weeks
Primary 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. 8 weeks
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