COPDNCT04020081
A Study to Evaluate the Effect of Yoga Exercises and Meditation on Lung Function and Quality of Life in COPD Patients.
A study testing Yoga breathing exercises and Meditation in people with COPD and Obstructive Pulmonary Disease, run by Chest Research Foundation, India at 1 site in India.
Trial summary
The Investigator would like to study the effect of yoga exercises and meditation on lung volume, respiratory impedance, 6-minute walk distance and quality of life in COPD patients. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- COPD, Obstructive Pulmonary Disease
- What is being tested?
- Yoga breathing exercises and Meditation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 9 Mar 2018to Jan 2020
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject who is willing to provide written informed consent.
- Male or female COPD patients aged ≥30 and < 70 years.
- Subjects who are willing to do yoga exercises.
- Clinical diagnosis of COPD confirmed on spirometry. Pre and post bronchodilator ratio of forced expiratory volume in 1sec/ forced vital capacity (FEV1/FVC) should be less than 0.7.
Who cannot join
- Active smoker.
- Pregnant women or nursing mothers. (Urine pregnancy test will be performed.)
- Those unable to perform spirometry and body plethysmography.
- Participants having symptoms of active pulmonary Koch's (tuberculosis).
- Contraindications for spirometry: Subject having any of the following contraindications for spirometry.
- History of the following a) Recent (within 1 month) myocardial infarction. b) Unstable heart condition c) Hemoptysis (blood in sputum on coughing) in recent past (1 month) or d) A recent (within last one month) eye, chest or abdominal surgery.
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- Contraindications for Body Plethysmography: Subject having any of the following contraindications for body plethysmography
- Mental confusion, muscular in coordination, body casts, or other conditions that prevent the subject from entering the plethysmograph cabinet or adequately performing the required maneuvers (i.e., panting against a closed shutter).
- History of Claustrophobia.
- Presence of devices or other conditions, such as continuous intravenous infusions with pumps or other equipment that will not fit into the plethysmograph, that should not be discontinued, or that might interfere with pressure changes (e.g., chest tube, trans tracheal O2 catheter, or ruptured eardrum).
- Anyone who is on continuous oxygen therapy
- Patients who are doing yoga or taking pulmonary rehabilitation from last 6 months.
- History of thoracic cage abnormality, musculoskeletal abnormality, interstitial lung disease, epilepsy
- Patients who are unable to perform yoga exercises.
- Contraindications for 6 Minute walk test:
- Absolute Contraindications: Unstable angina during the previous month and myocardial infarction during the previous month.
- Relative Contraindications : Resting heart rate of more than 120, a systolic blood pressure of more than 180 mm Hg, and a diastolic blood pressure of more than 100 mm Hg.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Chest Research Foundation
Pune, Maharashtra, 411014
Nitin Vanjare, M.Sc., +91 9970537116, vanjarenitin@crfindia.com
Shweta Rasam, B.Sc., +91 9881133834, shweta@crfindia.com
About this study
Official title: A Pilot Study to Evaluate the Effect of Yoga Exercises and Meditation on Lung Volume, Respiratory Impedance, 6-minute Walk Distance and Quality of Life in Chronic Obstructive Pulmonary Disease(COPD) Patients.
The Investigator would like to study the effect of yoga exercises and meditation on lung volume, respiratory impedance, 6-minute walk distance and quality of life in COPD patients.
Read the detailed description
Hypotheses : The Investigator hypothesized that Yoga exercises improve the lung function (i.e. decrease in the lung hyperinflation, air trapping and airway impedance) by stretching the lung tissue, strengthening the respiratory muscles and increasing the chest expansion. Yoga exercises help to increase exercise capacity. Meditation reduces anxiety and depression.
Research Question: Do yoga exercises and meditation help to reduce respiratory impedance, hyperinflation, air trapping and increase exercise capacity and improve quality of life in COPD patients compared to control arm?
Objectives: 1. To study the effect of yoga exercises and meditation on exercise capacity and quality of life in COPD patients after 4, 8 and 12-weeks of intervention.
2.To evaluate residual volume (RV), residual volume/ total lung volume RV/TLC, total lung capacity TLC,inspiratory capacity/total lung capacity IC/TLC, and respiratory impedance in COPD patients after 4, 8 and 12-weeks of yoga exercises and meditation practice.
- Conditions
- COPD, Obstructive Pulmonary Disease
- Being tested
- Yoga breathing exercises and Meditation
- Keywords
- Yoga, Meditation, COPD, Lung function
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga breathing exercises and MeditationOther
8 Breathing exercises.The first set of 6 exercises is of the Upper Lobe breathing (Upper and Middle Lobe of the Lungs) while 7th exercise is abdominal breathing,8th exercise is yogic breathing.
6-steps Nirmal Dhyan (meditation).Step 1: Breath awareness,Step 2: Body awareness,Step 3: Thought awareness,Step 4: Refreshing awareness,Step 5: Gap awareness,Step 6: Expanding awareness.
| Study group | Role | What they receive |
|---|---|---|
| Effect of yoga exercises in COPD patients after 12 weeks. | Experimental | Yoga group Receives: Other: Yoga breathing exercises and Meditation |
| COPD patients lung functions without yoga excercises. | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
St.George's Respiratory Questionnaires (SGRQ) score for quality of life in numbers.
Effect of Yoga Exercises and Meditation on SGRQ score after 12 week in COPD patients.
Measured: 3 Months
Exercise capacity 6 minute walk distance (6MWD) in meter.
Effect of Yoga Exercises and Meditation on 6 minute walk distance (6 MWD) after 12 week in COPD patients.
Measured: 3 Months.
Secondary outcomes (3)
RV/TLC in%
Effect of Yoga Exercises and Meditation on lung function after 12 week in COPD patients.
Measured: 3 Months
TLC in liters
Effect of Yoga Exercises and Meditation on lung function after 12 week in COPD patients.
Measured: 3 Months
Respiratory impedance in kpa/(L/s)
Effect of Yoga Exercises and Meditation on lung function after 12 week in COPD patients.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start9 Mar 2018
- Primary completion20 Dec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chest Research Foundation, India
- Sponsor type
- University, hospital or other
- Collaborators
- Jupiter Hospital, India
- Responsible party
- Principal investigator, Dr.Sundeep S Salvi, Chest Research Foundation, India
- Investigators
- Dr. Sundeep Salvi, MD, Principal investigator, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020081
- Sponsor's protocol ID
- CRF/01/2017
- Status last verified
- Jul 2019
- First submitted
- 3 Jun 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Donesky-Cuenco D, Nguyen HQ, Paul S, Carrieri-Kohlman V. Yoga therapy decreases dyspnea-related distress and improves functional performance in people with chronic obstructive pulmonary disease: a pilot study. J Altern Complement Med. 2009 Mar;15(3):225-34. doi: 10.1089/acm.2008.0389.
PubMed 19249998Kaminsky DA, Guntupalli KK, Lippmann J, Burns SM, Brock MA, Skelly J, DeSarno M, Pecott-Grimm H, Mohsin A, LaRock-McMahon C, Warren P, Whitney MC, Hanania NA. Effect of Yoga Breathing (Pranayama) on Exercise Tolerance in Patients with Chronic Obstructive Pulmonary Disease: A Randomized, Controlled Trial. J Altern Complement Med. 2017 Sep;23(9):696-704. doi: 10.1089/acm.2017.0102. Epub 2017 Jul 17.
PubMed 28714735Liu XC, Pan L, Hu Q, Dong WP, Yan JH, Dong L. Effects of yoga training in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. J Thorac Dis. 2014 Jun;6(6):795-802. doi: 10.3978/j.issn.2072-1439.2014.06.05.
PubMed 24977005
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Effect of Yoga Exercises and Meditation on Lung Volume, Respiratory Impedance, 6-minute Walk Distance and Quality of Life in Chronic Obstructive Pulmonary Disease(COPD) Patients.
- ClinicalTrials.gov ID
- NCT04020081
- Acronym / sponsor ID
- CRF/01/2017
- Conditions
- COPD, Obstructive Pulmonary Disease
- Keywords
- Yoga, Meditation, COPD, Lung function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chest Research Foundation, IndiaUniversity, hospital or other
- Collaborators
- Jupiter Hospital, India
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 20 Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 15 Jul 2019 (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 Investigator would like to study the effect of yoga exercises and meditation on lung volume, respiratory impedance, 6-minute walk distance and quality of life in COPD patients.
Detailed description
Hypotheses : The Investigator hypothesized that Yoga exercises improve the lung function (i.e. decrease in the lung hyperinflation, air trapping and airway impedance) by stretching the lung tissue, strengthening the respiratory muscles and increasing the chest expansion. Yoga exercises help to increase exercise capacity. Meditation reduces anxiety and depression.
Research Question: Do yoga exercises and meditation help to reduce respiratory impedance, hyperinflation, air trapping and increase exercise capacity and improve quality of life in COPD patients compared to control arm?
Objectives: 1. To study the effect of yoga exercises and meditation on exercise capacity and quality of life in COPD patients after 4, 8 and 12-weeks of intervention.
2.To evaluate residual volume (RV), residual volume/ total lung volume RV/TLC, total lung capacity TLC,inspiratory capacity/total lung capacity IC/TLC, and respiratory impedance in COPD patients after 4, 8 and 12-weeks of yoga exercises and meditation practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effect of yoga exercises in COPD patients after 12 weeks. | Experimental | Other: Yoga breathing exercises and MeditationYoga group |
| COPD patients lung functions without yoga excercises. | No intervention | –Control group |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject who is willing to provide written informed consent.
- Male or female COPD patients aged ≥30 and < 70 years.
- Subjects who are willing to do yoga exercises.
- Clinical diagnosis of COPD confirmed on spirometry. Pre and post bronchodilator ratio of forced expiratory volume in 1sec/ forced vital capacity (FEV1/FVC) should be less than 0.7.
Key exclusion criteria (17 listed)
- Active smoker.
- Pregnant women or nursing mothers. (Urine pregnancy test will be performed.)
- Those unable to perform spirometry and body plethysmography.
- Participants having symptoms of active pulmonary Koch's (tuberculosis).
- Contraindications for spirometry: Subject having any of the following contraindications for spirometry.
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 |
|---|---|---|
| Yoga breathing exercises and Meditation8 Breathing exercises.The first set of 6 exercises is of the Upper Lobe breathing (Upper and Middle Lobe of the Lungs) while 7th exercise is abdominal breathing,8th exercise is yogic breathing. 6-steps Nirmal Dhyan (meditation).Step 1: Breath awareness,Step 2: Body awareness,Step 3: Thought awareness,Step 4: Refreshing awareness,Step 5: Gap awareness,Step 6: Expanding awareness. | Other | Effect of yoga exercises in COPD patients after 12 weeks. |
Primary outcome
St.George's Respiratory Questionnaires (SGRQ) score for quality of life in numbers.
Time frame: 3 Months
Effect of Yoga Exercises and Meditation on SGRQ score after 12 week in COPD patients.
Exercise capacity 6 minute walk distance (6MWD) in meter.
Time frame: 3 Months.
Effect of Yoga Exercises and Meditation on 6 minute walk distance (6 MWD) after 12 week in COPD patients.
3 secondary outcomes
RV/TLC in%
Time frame: 3 Months
TLC in liters
Time frame: 3 Months
Respiratory impedance in kpa/(L/s)
Time frame: 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Background: PubMed 19249998Donesky-Cuenco D, Nguyen HQ, Paul S, Carrieri-Kohlman V. Yoga therapy decreases dyspnea-related distress and improves functional performance in people with chronic obstructive pulmonary disease: a pilot study. J Altern Complement Med. 2009 Mar;15(3):225-34. doi: 10.1089/acm.2008.0389.
- Background: PubMed 28714735Kaminsky DA, Guntupalli KK, Lippmann J, Burns SM, Brock MA, Skelly J, DeSarno M, Pecott-Grimm H, Mohsin A, LaRock-McMahon C, Warren P, Whitney MC, Hanania NA. Effect of Yoga Breathing (Pranayama) on Exercise Tolerance in Patients with Chronic Obstructive Pulmonary Disease: A Randomized, Controlled Trial. J Altern Complement Med. 2017 Sep;23(9):696-704. doi: 10.1089/acm.2017.0102. Epub 2017 Jul 17.
- Results publication: PubMed 24977005Liu XC, Pan L, Hu Q, Dong WP, Yan JH, Dong L. Effects of yoga training in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. J Thorac Dis. 2014 Jun;6(6):795-802. doi: 10.3978/j.issn.2072-1439.2014.06.05.
- Individual participant dataSharing planned: No
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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.
Dr. Sundeep Salvi, MD principal investigator
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga breathing exercises and Meditation in people with COPD and Obstructive Pulmonary Disease, run by Chest Research Foundation, India at 1 site in India.
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 4 inclusion and 17 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 15 Jul 2019. 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 India. 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?
Contact Nitin Vanjare, M.Sc. (+91 9970537116, vanjarenitin@crfindia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
St.George's Respiratory Questionnaires (SGRQ) score for quality of life in numbers. (time frame: 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04020081, which also lists 3 linked publications.
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 15 Jul 2019.