NCT05684926

Brief Summary

In our study, yoga asana and pranayama practices, which will be applied by video call from computer or phone, will be advantageous in terms of time, transportation and access to asthmatic children whose anxiety and anxiety levels increase during the COVID-19 period, whose access to hospital services is difficult, and whose physical activity level decreases due to the increase in screen time. It was aimed to examine the effects of these group exercises on Asthma Control, Functional Capacity, Physical Fitness, Physical Activity and Quality of Life. In the randomized controlled study, the treatment and control group will be determined by the closed envelope method, the control group will be placed on the waiting list and yoga will be practiced at the end of the study. The first and final evaluation will be done face to face in a clinical setting. The total duration will be 12 weeks, 3 days a week and 36 sessions between 8-8:40 in the evening. Researchers who will do yoga have a certificate of practice. Patients will be followed up in Hacettepe University Medical Faculty Asthma Allergy Clinic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

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

September 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1 month

First QC Date

January 12, 2023

Last Update Submit

March 13, 2024

Conditions

Keywords

AsthmaRehabilitationPhysical FitnessPhysical activity

Outcome Measures

Primary Outcomes (1)

  • respiratory function (pulmoner function test)

    It is evaluated with the Pulmonary Function Test. After a deep, full inspiration, a forced expiratory maneuver is performed. Used with disposable antiviral filter. The patient's height and body weight are measured and recorded with age. It is done 3 times, there should be no more than 10% difference between the values. The highest value is accepted.

    one day

Secondary Outcomes (7)

  • asthma control

    one day

  • functional capacity

    one day

  • physical fitness

    one day

  • physical activity

    one day

  • pediatric asthma quality of life questionnaire

    one day

  • +2 more secondary outcomes

Study Arms (2)

Experimental Group

EXPERIMENTAL

The intervention group is a group of asthmatic children aged 6-11 years, determined by randomization. Yoga asana includes pranayama and concentration. It will be held 3 days a week for 12 weeks.

Other: Telerehabilitation yoga

Control Group

NO INTERVENTION

The control group is a group of asthmatic children aged 6-11 years, determined by randomization method. He will be put on the waiting list and after the second evaluation, yoga exercises will be done for 8 weeks.

Interventions

Yoga consists of bodily postures or poses called asanas, breathing practices called pranayama, and meditation sections that provide focus. Children's yoga aims to teach pre-school (3-6 years) and school (7-12 years) children to breathe correctly, to practice yoga postures using their imaginations, to preserve their existing body flexibility and to teach correct posture. It consists of compositions such as postures, breathing exercises, imitations of living things in nature, memory games. They also relax with the pranayama breathing exercises done during the session. It aims to develop children's creativity through relaxation exercises, moving poses and stories told. Children's yoga also serves an artistic aspect with activities such as listening to music, singing, rhythm games, and drawing.

Also known as: Yoga/Pranayama
Experimental Group

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Hacettepe University Faculty of Medicine, Department of Pediatrics, Allergy and Asthma Unit patients were referred for Cardiopulmonary Rehabilitation,
  • Those who have been diagnosed with asthma,
  • Not in an asthma attack but clinically stable,
  • Between the ages of 6-11,
  • Giving consent on a voluntary basis,
  • cooperative,
  • Ability to use a smart phone or computer,

You may not qualify if:

  • Individuals with internet connection will be included in the research. Individuals with asthma were included in the study.
  • In an asthma attack and clinically unstable,
  • Having serious diseases such as cancers, heart failure and acute respiratory infections,
  • Having chronic lung disease other than asthma,
  • Severe neuromuscular and musculoskeletal problems,
  • Uncooperative to make surveys and scales,
  • Admitted or hospitalized due to an asthma attack in the last 3 months for safety reasons,
  • Having neuropsychiatric diseases,
  • Individuals who do not volunteer to participate in the study will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AsthmaMotor Activity

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 13, 2023

Study Start

September 1, 2022

Primary Completion

October 15, 2022

Study Completion

May 15, 2023

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations