NCT04107415

Brief Summary

This study was conducted to find out the effect of yoga applied to asthma patients on the patients' respiratory functions, symptom control and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable asthma

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

4 months

First QC Date

September 21, 2019

Last Update Submit

September 25, 2019

Conditions

Keywords

Asthmanursingpatientyoga

Outcome Measures

Primary Outcomes (3)

  • Asthma Quality of Life Questionnaire

    Performed to determine the quality of life of asthma patients. Asthma Quality of Life Questionnaire , which addresses both the physical and emotional aspects of the disease has 32 items and four sub-dimensions. These sub-dimensions are activity limitation (items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32), symptoms (items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30), emotional functions (items 7, 13, 15, 21, 27) and environmental stimulants (items 9, 17, 23, 26). The scale is a 7-Likert type scale with "1" having the lowest point and "7" the highest point. Weights for the points of the questions are equal. General quality of life is calculated with the averages of all questions, while sub-dimensions are calculated by adding the scores of the related fields. Total score of the scale differs between 32 and 224. Higher total score and sub-dimension score averages mean higher quality of life. diagnosis

    6 week

  • Asthma Control Test

    The test consists of 5 questions. In this 5-Likert type scale, the scores of the answers are added up and the patient's state is evaluated. The maximum score one can get from this test is 25, while the minimum score is 5. While scoring Asthma Control Test, 25 points is accepted as "full control", 20-24 points is accepted as "good control" and less than 19 points is accepted as "no control". The highest score indicates the best control, while scores less than 19 indicate that the disease is not under control and that modifications should be made in the treatment to reach control.

    6 week

  • Respiratory Function tests

    Respiratory Function tests is a physiological parameter. Respiratory Function tests are assessed to find out the degree of airway constriction with spirometer and also to find out whether the disease is reversible and to make asthma diagnosis. Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), peak expiratory flow rate (PEF) and FEV1/FVC measurements were used to evaluate airway constriction

    6 week

Study Arms (2)

Yoga group

EXPERIMENTAL

group doing yoga

Other: yoga

No yoga group

NO INTERVENTION

group not doing yoga

Interventions

yogaOTHER

A total of 12 yoga sessions, 2 sessions a week for 6 weeks, was applied to the patients in the experimental group.

Yoga group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • must be between 18 and 55 years old
  • must be diagnosed with asthma at least for six months,
  • must be living in the city centre,
  • must be literate and volunteered to participated in the study, were included in the study

You may not qualify if:

  • be participated in a regular exercise program in the last 6 months,
  • be have another respiratory system disease
  • be in the exacerbation period,
  • have a physical disease or cognitive deficiency and a psychiatric disease diagnosis that could prevent understanding the training given,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk university nursing faculty

Erzurum, Center, 25240, Turkey (Türkiye)

Location

Related Publications (2)

  • Kavak F, Ekinci M. The Effect of Yoga on Functional Recovery Level in Schizophrenic Patients. Arch Psychiatr Nurs. 2016 Dec;30(6):761-767. doi: 10.1016/j.apnu.2016.07.010. Epub 2016 Jul 30.

    PMID: 27888972BACKGROUND
  • Bahcecioglu Turan G, Tan M. The effect of yoga on respiratory functions, symptom control and life quality of asthma patients: A randomized controlled study. Complement Ther Clin Pract. 2020 Feb;38:101070. doi: 10.1016/j.ctcp.2019.101070. Epub 2019 Oct 28.

MeSH Terms

Conditions

Asthma

Interventions

Yoga

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Gülcan Bahçecioğlu Turan, Dr.

    Ataturk Üniversty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomization; participants were divided into two groups by using simple random numbers table, and then the first group which was drawn by lot method was named as the experimental group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor Research Assistant

Study Record Dates

First Submitted

September 21, 2019

First Posted

September 27, 2019

Study Start

December 15, 2017

Primary Completion

April 15, 2018

Study Completion

December 15, 2018

Last Updated

September 27, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

after the article is published

Locations