search
Back to results

EFFECT OF PRANAYAMA YOGA ON COPD (COPD)

Primary Purpose

Asthma, Chronic Obstructive Pulmonary Disease (COPD), or Chronic Lung Disease (E.G., Chronic Bronchitis and Restrictive Lung Diseases Such as Asbestosis), The Effect of Yoga, Paranayama Yoga Practice on Respiratory Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pranayama Yoga
Sponsored by
Yeditepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma, Chronic Obstructive Pulmonary Disease (COPD), or Chronic Lung Disease (E.G., Chronic Bronchitis and Restrictive Lung Diseases Such as Asbestosis) focused on measuring Pranayama Yoga, COPD, Semptoms, Fatigue, Pulmonary functions

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Between the ages of 40-65 To have been diagnosed with Stage I or Stage II COPD for at least six months Absence of any communication problem [decreased hearing, visual impairment, inability to understand/speak Turkish] that would prevent participation in the research, Least literate Do not have any mental or physical disability that would prevent them from practicing Pranayama Yoga. Not having done pranayama yoga before No tracheostomy Telephone communication is possible. The patients who accepted to participate in the study voluntarily constitute the sample of the study. Exclusion Criteria: Being diagnosed with Stage III and Stage IV COPD, Patients under the age of 40 and not over the age of 65 Individuals who are bored during the interview and give up on the interview will not be included in the study and their data will not be used.

Sites / Locations

  • UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pranayam Yoga Group

Non-Pranayama Yoga Group

Arm Description

It was planned to use a simple random sampling method among individuals who met the research inclusion criteria and agreed to participate voluntarily in the study. During randomization; Patients in the study and control groups will be determined using the random.org site. While the routine treatment of the patients in the study group continues, 20 minutes of pranayama yoga training will be given by the yoga instructor to the patient and his relatives, and it is planned that the patient will practice pranayama yoga, which is taught for 20 minutes every day for 21 days. Patients or their relatives will be called every morning by phone or video communication will be made online and pranayama yoga will be provided. In addition, a training booklet describing pranayama yoga exercises in detail, a training video and a 21-day checklist of doing yoga will be given to the patients. function test will be done and checklists will be taken back from patients.

The routine treatment of the control group will continue and any intervention will not be applied. After the data collection process of the study is completed, paranayama yoga training will be given to the patients in the control group and they will be advised to do it regularly for at least 21 days.

Outcomes

Primary Outcome Measures

COPD Assesment Test (CAT)
Assesment Test

Secondary Outcome Measures

SPIROMETER
MIR-Spirobank Portable Spirometer
Asthma Fatigue Scale (CAFS)
Assesment Test

Full Information

First Posted
July 23, 2023
Last Updated
September 1, 2023
Sponsor
Yeditepe University
search

1. Study Identification

Unique Protocol Identification Number
NCT06022627
Brief Title
EFFECT OF PRANAYAMA YOGA ON COPD
Acronym
COPD
Official Title
EFFECT OF PRANAYAMA YOGA ON SYMPTOMS, FATIGUE AND RESPIRATORY PARAMETERS IN INDIVIDUALS WITH COPD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2023 (Anticipated)
Primary Completion Date
September 16, 2023 (Anticipated)
Study Completion Date
September 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yeditepe 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
The aim of the study In this study, pranayama yoga practices are the sub-dimensions of respiratory parameters, symptom and disease affection level, psychosocial adjustment and psychosocial adjustment in individuals with COPD. It was planned in a randomized controlled manner to examine the effects of healthcare compliance, professional environment, family environment, sexual relations, extended family relationships, social environment and psychological pressure. Pranayama yoga practices are aimed to reduce the frequency of symptoms and the level of disease exposure in individuals with COPD. Pranayama yoga practices are aimed to increase psychosocial adjustment in individuals with COPD. Pranayama yoga practices aim to increase compliance with health care, occupational, social and family environment, sexual and extended family relationships, and psychological pressure, which are the sub-dimensions of psychosocial adjustment in individuals with COPD. It is observed that all the yoga practices performed have improved the pulmonary functions of individuals with COPD, decrease the severity of symptoms, relieve inflammation, and increase muscle strength and physical performance. It was concluded that because of yoga increases awareness in patients, patients significantly reduce their level of depression and anxiety and adapt to social life. Yoga improves patients' quality of life by alleviating symptoms and increasing self-awareness. pranayama yoga practices are safe, home-applied, effective, cost-effective, complementary to drug therapy and can be performed during pulmonary rehabilitation for individuals with COPD (1-2) . The results of this study are important in guiding caregivers and healthcare professionals during the holistic care of COPD individuals and in pulmonary rehabilitation.
Detailed Description
Deep breathing exercises called pranayama yoga increase the oxygen and diffusion capacity of the alveolar in the lungs and facilitate gas exchange (1-3). Thus, tissue perfusion increases, more oxygen binds to hemoglobin and is transported (4-5). Material and Method Purpose and Type of Study: This study was planned as a randomized controlled study to examine the effects of pranayama yoga practices on symptoms, fatigue and respiratory parameters in individuals with COPD. Research Goals Pranayama yoga practices are aimed to increase the FEV1, FVC, FV1/FVC … parameters of individuals with COPD. Pranayama yoga practices are aimed at improving the symptom level of individuals with COPD. Pranayama yoga practices are aimed at reducing fatigue levels in individuals with COPD. Research Hypotheses H1: Pranayama yoga increases COPD respiratory parameters (FEV1, FVC, FV1/FVC, PEF, FEF AND VC) H2: Pranayama yoga reduces COPD symptom level H3: Pranayama yoga reduces COPD fatigue level Patient selection and administration The study was conducted using simple random sampling method among individuals with COPD who met the inclusion criteria and voluntarily agreed to participate in the study. Patients GOLD, 2021 COPD classification, disease stages of the patients were determined and 66 patients with group B Stage I and Stage II COPD were included in the study. The patients included in the study were numbered by identifying the patients in the study and control groups using the random.org website. 66 individuals with COPD included by randomization were divided into two groups as 33 (16 Stage I and 17 Stage II) study group and 33 (16 Stage I and 17 Stage II) control group. According to the spirometric FEV 1 values of the patients in the study and control groups, 16 patients with Stage I and 17 Stage II COPD in each group were included in the study. While the routine treatment of the patients in the study group continued, 20 minutes of pranayama yoga training was given to the patient and his relatives by the yoga instructor (researcher), and it was planned that the patient would practice pranayama yoga, which was taught for 20 minutes a day for 21 days. In addition, patients will be given a training booklet detailing pranayama yoga exercises, a training video, and a 21-day checklist of practicing yoga. Patients or their relatives will be called every morning by phone or online communication will be established and pranayama yoga will be provided. After the application is over, the patients will be visited at the hospital or at their homes, and the re-interview form, COPD Assessment Test (CAT), COPD and Asthma Fatigue Scale (CAFS) will be filled and pulmonary function test will be performed and checklists will be taken back from the patients. The routine treatment of the control group will continue and no intervention will be applied. After the data collection process of the study is completed, paranayama yoga training will be given to the patients in the control group and they will be advised to do it regularly for at least 21 days. Resources Ranjita, R., Hankey, A., Nagendra, H. R., & Mohanty, S. (b2016). Yoga-based pulmonary rehabilitation for the management of dyspnea in coal miners with chronic obstructive pulmonary disease: a randomized controlled trial. Journal of Ayurveda and integrative medicine, 7(3), 158-166. Soni, R., Munish, K., Singh, K. P., & Singh, S. (2012). Study of the effect of yoga training on diffusion capacity in chronic obstructive pulmonary disease patients: A controlled trial. International journal of yoga, 5(2), 123. Zeng, Y., Jiang, F., Chen, Y., Chen, P., & Cai, S. (2018). Exercise assessments and trainings of pulmonary rehabilitation in COPD: a literature review. International journal of chronic obstructive pulmonary disease, 2013-2023. Li, C., Liu, Y., Ji, Y., Xie, L., & Hou, Z. (2018). Efficacy of yoga training in chronic obstructive pulmonary disease patients: a systematic review and meta-analysis. Complementary therapies in clinical practice, 30, 33-37. doi: 10.1016/j.ctcp.2017.11.006 Pomidori, L., Campigotto, F., Amatya, T. M., Bernardi, L., & Cogo, A. (2009). Efficacy and tolerability of yoga breathing in patients with chronic obstructive pulmonary disease: a pilot study. Journal of cardiopulmonary rehabilitation and prevention, 29(2), 133-137. Available at: https://insights.ovid.com/pubmed?pmid=1930523. Thokchom, S. K., Gulati, K., Ray, A., & Menon, B. K. (2018). Effects of yogic intervention on pulmonary functions and health status in patients of COPD and the possible mechanisms. Complementary Therapies in Clinical Practice, 33, 20-26. doi: 10.1016/j.ctcp.2018.07.008

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Chronic Obstructive Pulmonary Disease (COPD), or Chronic Lung Disease (E.G., Chronic Bronchitis and Restrictive Lung Diseases Such as Asbestosis), The Effect of Yoga, Paranayama Yoga Practice on Respiratory Diseases
Keywords
Pranayama Yoga, COPD, Semptoms, Fatigue, Pulmonary functions

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
66 individuals with COPD included by randomization were divided into two groups as 33 (16 Stage I and 17 Stage II) study group and 33 (16 Stage I and 17 Stage II) control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pranayam Yoga Group
Arm Type
Experimental
Arm Description
It was planned to use a simple random sampling method among individuals who met the research inclusion criteria and agreed to participate voluntarily in the study. During randomization; Patients in the study and control groups will be determined using the random.org site. While the routine treatment of the patients in the study group continues, 20 minutes of pranayama yoga training will be given by the yoga instructor to the patient and his relatives, and it is planned that the patient will practice pranayama yoga, which is taught for 20 minutes every day for 21 days. Patients or their relatives will be called every morning by phone or video communication will be made online and pranayama yoga will be provided. In addition, a training booklet describing pranayama yoga exercises in detail, a training video and a 21-day checklist of doing yoga will be given to the patients. function test will be done and checklists will be taken back from patients.
Arm Title
Non-Pranayama Yoga Group
Arm Type
No Intervention
Arm Description
The routine treatment of the control group will continue and any intervention will not be applied. After the data collection process of the study is completed, paranayama yoga training will be given to the patients in the control group and they will be advised to do it regularly for at least 21 days.
Intervention Type
Behavioral
Intervention Name(s)
Pranayama Yoga
Intervention Description
Doing practice of paranayam yoga which including breathing exercises yoga-life energy
Primary Outcome Measure Information:
Title
COPD Assesment Test (CAT)
Description
Assesment Test
Time Frame
21 days
Secondary Outcome Measure Information:
Title
SPIROMETER
Description
MIR-Spirobank Portable Spirometer
Time Frame
21 days
Title
Asthma Fatigue Scale (CAFS)
Description
Assesment Test
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Between the ages of 40-65 To have been diagnosed with Stage I or Stage II COPD for at least six months Absence of any communication problem [decreased hearing, visual impairment, inability to understand/speak Turkish] that would prevent participation in the research, Least literate Do not have any mental or physical disability that would prevent them from practicing Pranayama Yoga. Not having done pranayama yoga before No tracheostomy Telephone communication is possible. The patients who accepted to participate in the study voluntarily constitute the sample of the study. Exclusion Criteria: Being diagnosed with Stage III and Stage IV COPD, Patients under the age of 40 and not over the age of 65 Individuals who are bored during the interview and give up on the interview will not be included in the study and their data will not be used.
Facility Information:
Facility Name
University
City
Istanbul
State/Province
Ataşehir
ZIP/Postal Code
34758
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selman ÇELİK, PHD
Phone
05423440717
Email
selman.celik@yeditepe.edu.tr
First Name & Middle Initial & Last Name & Degree
Sıdıka OĞUZ, PROF.
Phone
05334651099
Email
soguz@marmara.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

EFFECT OF PRANAYAMA YOGA ON COPD

We'll reach out to this number within 24 hrs