Asthma, Chronic Obstructive Pulmonary Disease (COPD), or Chronic Lung Disease (E.G., Chronic Bronchitis and Restrictive Lung Diseases Such as Asbestosis)COPDNCT06022627
EFFECT OF PRANAYAMA YOGA ON COPD
A study testing Pranayama Yoga in people with Asthma, Chronic Obstructive Pulmonary Disease (COPD), or Chronic Lung Disease (E.G., Chronic Bronchitis and Restrictive Lung Diseases Such as Asbestosis) and The Effect of Yoga, Paranayama Yoga Practice on Respiratory Diseases, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- 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
- What is being tested?
- Pranayama Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2023to 20 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- No tracheostomy
- Telephone communication is possible.
- The patients who accepted to participate in the study voluntarily constitute the sample of the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University
Istanbul, Ataşehir, 34758
Selman ÇELİK, PHD, 05423440717, selman.celik@yeditepe.edu.tr
Sıdıka OĞUZ, PROF., 05334651099, soguz@marmara.edu.tr
About this study
Official title: EFFECT OF PRANAYAMA YOGA ON SYMPTOMS, FATIGUE AND RESPIRATORY PARAMETERS IN INDIVIDUALS WITH COPD
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.
Read the 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
- Conditions
- 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
- Being tested
- Pranayama Yoga
- Keywords
- Pranayama Yoga, COPD, Semptoms, Fatigue, Pulmonary functions
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pranayama YogaBehavioural
Doing practice of paranayam yoga which including breathing exercises yoga-life energy
| Study group | Role | What they receive |
|---|---|---|
| Pranayam Yoga Group | Experimental | 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. Receives: Behavioral: Pranayama Yoga |
| Non-Pranayama Yoga Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD Assesment Test (CAT)
Assesment Test
Measured: 21 days
Secondary outcomes (2)
SPIROMETER
MIR-Spirobank Portable Spirometer
Measured: 21 days
Asthma Fatigue Scale (CAFS)
Assesment Test
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start25 Aug 2023 (estimated)
- Primary completion16 Sep 2023 (estimated)
- Study completion20 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, Chronic Obstructive Pulmonary Disease (COPD), or Chronic Lung Disease (E.G., Chronic Bronchitis and Restrictive Lung Diseases Such as Asbestosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022627
- Sponsor's protocol ID
- 1707
- Acronym
- COPD
- Status last verified
- Sep 2023
- First submitted
- 23 Jul 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF PRANAYAMA YOGA ON SYMPTOMS, FATIGUE AND RESPIRATORY PARAMETERS IN INDIVIDUALS WITH COPD
- ClinicalTrials.gov ID
- NCT06022627
- Acronym / sponsor ID
- COPD / 1707
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 25 Aug 2023 (estimated)
- Primary completion
- 16 Sep 2023 (estimated)
- Study completion
- 20 Sep 2023 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pranayam Yoga Group | Experimental | Behavioral: Pranayama YogaIt 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. |
| Non-Pranayama Yoga Group | No intervention | –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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pranayama YogaDoing practice of paranayam yoga which including breathing exercises yoga-life energy | Behavioural | Pranayam Yoga Group |
Primary outcome
COPD Assesment Test (CAT)
Time frame: 21 days
Assesment Test
2 secondary outcomes
SPIROMETER
Time frame: 21 days
Asthma Fatigue Scale (CAFS)
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pranayama Yoga in people with Asthma, Chronic Obstructive Pulmonary Disease (COPD), or Chronic Lung Disease (E.G., Chronic Bronchitis and Restrictive Lung Diseases Such as Asbestosis) and The Effect of Yoga, Paranayama Yoga Practice on Respiratory Diseases, run by Yeditepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD Assesment Test (CAT) (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.