NCT04658563

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
Last Updated

May 24, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

October 22, 2020

Last Update Submit

May 21, 2021

Conditions

Yoga

Keywords

Yogaphysical fitnessadolescentquality of lifesleep quality

Outcome Measures

Primary Outcomes (13)

  • 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

  • Assessment of Health-Related Physical Fitness - Lower extremity flexibility

    Sit and Reach Test will be performed to assess lower extremity flexibility.

    8 weeks

  • Assessment of Health-Related Physical Fitness - Balance

    Time up-go test will be performed to evaluate the balance levels of the patients.

    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

    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.

    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.

    8 weeks

  • Forced vital capacity (FVC)

    Forced vital capacity (FVC) will be measured in Liter and %.

    8 weeks

  • First-second forced expiratory volume (FEV1)

    First-second forced expiratory volume (FEV1) will be measured in Liter and %.

    8 weeks

  • Peak flow rate (PEF)

    Peak flow rate (PEF) will be measured in Liter/second.

    8 weeks

  • 25-75% of forced expiratory flow rate (FEF (25-75%)

    25-75% of forced expiratory flow rate will be measured in Liter.

    8 weeks

  • Inspiratory capacity (IC)

    Inspiratory capacity (IC) will be measured in Liter.

    8 weeks

  • Vital capacity (VC)

    Vital capacity (VC) will be measured in Liter.

    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.

    8 weeks

Study Arms (2)

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.

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

Interventions

High Density Exercise Training Program - YogaOTHER

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

Also known as: Yoga
Group 1: Yoga

Eligibility Criteria

Age14 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- Female adolescents between the ages of 14 and 18

You may not qualify if:

  • \- Individuals with recent muscular skeletal, neuromuscular and chronic systemic diseases that could prevent exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Ankara, 06790, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Yoga

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Proffesor

Study Record Dates

First Submitted

October 22, 2020

First Posted

December 8, 2020

Study Start

October 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

May 24, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)