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The Effect of Yoga on Respiratory Functions, Symptom Control and Life Quality of Asthma Patients

Primary Purpose

Asthma, Yoga

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
yoga
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring Asthma, nursing, patient, yoga

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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,

Sites / Locations

  • Atatürk university nursing faculty

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Yoga group

No yoga group

Arm Description

group doing yoga

group not doing yoga

Outcomes

Primary Outcome Measures

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
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.
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

Secondary Outcome Measures

Full Information

First Posted
September 21, 2019
Last Updated
September 25, 2019
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT04107415
Brief Title
The Effect of Yoga on Respiratory Functions, Symptom Control and Life Quality of Asthma Patients
Official Title
The Effect of Yoga on Respiratory Functions, Symptom Control and Life Quality of Asthma Patients: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
April 15, 2018 (Actual)
Study Completion Date
December 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
While there are studies conducted with yoga on different patient groups in Turkey, no studies have been found on asthma patients specifically. For this reason, it was thought that studies are needed which will prove the effect of yoga practices in preventing and controlling symptoms of asthma patients and which will contribute to nursing literature.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Yoga
Keywords
Asthma, nursing, patient, yoga

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Investigator
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga group
Arm Type
Experimental
Arm Description
group doing yoga
Arm Title
No yoga group
Arm Type
No Intervention
Arm Description
group not doing yoga
Intervention Type
Other
Intervention Name(s)
yoga
Intervention Description
A total of 12 yoga sessions, 2 sessions a week for 6 weeks, was applied to the patients in the experimental group.
Primary Outcome Measure Information:
Title
Asthma Quality of Life Questionnaire
Description
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
Time Frame
6 week
Title
Asthma Control Test
Description
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.
Time Frame
6 week
Title
Respiratory Function tests
Description
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
Time Frame
6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülcan Bahçecioğlu Turan, Dr.
Organizational Affiliation
Ataturk Üniversty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atatürk university nursing faculty
City
Erzurum
State/Province
Center
ZIP/Postal Code
25240
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
after the article is published
Citations:
PubMed Identifier
27888972
Citation
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.
Results Reference
background
PubMed Identifier
31679902
Citation
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.
Results Reference
derived

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The Effect of Yoga on Respiratory Functions, Symptom Control and Life Quality of Asthma Patients

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