Yoga for Adolescents

• ClinicalTrials.gov Identifier: NCT04658563
• Recruitment Status: Completed
• First Posted: December 8, 2020
• Last Update Posted: May 24, 2021
• Sponsor: Baskent University
• Information provided by (Responsible Party): Neslihan Duruturk, Baskent University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Yoga	Other: High Density Exercise Training Program - Yoga	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Effect of High Density Hatha Yoga Training on Physical Fitness, Respiratory Functions and Quality of Life in Healthy Adolescents
• Actual Study Start Date: October 1, 2020
• Actual Primary Completion Date: December 1, 2020
• Actual Study Completion Date: December 1, 2020

Arms and Interventions

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.	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; Other Name: Yoga
No Intervention: Group 2: Control; Individuals in the second group will not included in any exercise training program

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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
5. 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.
6. 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.
7. Forced vital capacity (FVC) [ Time Frame: 8 weeks ]
   Forced vital capacity (FVC) will be measured in Liter and %.
8. First-second forced expiratory volume (FEV1) [ Time Frame: 8 weeks ]
   First-second forced expiratory volume (FEV1) will be measured in Liter and %.
9. Peak flow rate (PEF) [ Time Frame: 8 weeks ]
   Peak flow rate (PEF) will be measured in Liter/second.
10. 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.
11. Inspiratory capacity (IC) [ Time Frame: 8 weeks ]
    Inspiratory capacity (IC) will be measured in Liter.
12. Vital capacity (VC) [ Time Frame: 8 weeks ]
    Vital capacity (VC) will be measured in Liter.
13. 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.

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Turkey

Baskent University

Ankara, Turkey, 06790

Sponsors and Collaborators

Baskent University

More Information

• Responsible Party: Neslihan Duruturk, Associated Proffesor, Baskent University
• ClinicalTrials.gov Identifier: NCT04658563
• Other Study ID Numbers: KA18 / 345
• First Posted: December 8, 2020
• Last Update Posted: May 24, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Neslihan Duruturk, Baskent University:

Yoga; physical fitness; adolescent; quality of life; sleep quality