A Study to Evaluate the Effect of Yoga Exercises and Meditation on Lung Function and Quality of Life in COPD Patients.

NCT ID: NCT04020081

Last Updated: 2019-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-09

Study Completion Date

2020-01-31

Brief Summary

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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

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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

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COPD Obstructive Pulmonary Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Effect of yoga exercises in COPD patients after 12 weeks.

Yoga group

Group Type EXPERIMENTAL

Yoga breathing exercises and Meditation

Intervention Type OTHER

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.

COPD patients lung functions without yoga excercises.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Yoga breathing exercises and Meditation

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Subject who is willing to provide written informed consent.
2. Male or female COPD patients aged ≥30 and \< 70 years.
3. Subjects who are willing to do yoga exercises.
4. 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.

Exclusion Criteria

1. Active smoker.
2. Pregnant women or nursing mothers. (Urine pregnancy test will be performed.)
3. Those unable to perform spirometry and body plethysmography.
4. Participants having symptoms of active pulmonary Koch's (tuberculosis).
5. 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.
6. Contraindications for Body Plethysmography: Subject having any of the following contraindications for body plethysmography

1. 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).
2. History of Claustrophobia.
3. 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).
7. Anyone who is on continuous oxygen therapy
8. Patients who are doing yoga or taking pulmonary rehabilitation from last 6 months.
9. History of thoracic cage abnormality, musculoskeletal abnormality, interstitial lung disease, epilepsy
10. Patients who are unable to perform yoga exercises.
11. Contraindications for 6 Minute walk test:

1. Absolute Contraindications: Unstable angina during the previous month and myocardial infarction during the previous month.
2. 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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jupiter Hospital, India

UNKNOWN

Sponsor Role collaborator

Chest Research Foundation, India

OTHER

Sponsor Role lead

Responsible Party

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Dr.Sundeep S Salvi

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Sundeep Salvi, MD

Role: PRINCIPAL_INVESTIGATOR

Director

Locations

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Chest Research Foundation

Pune, Maharashtra, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Nitin Vanjare, M.Sc.

Role: CONTACT

+91 9970537116

Shweta Rasam, B.Sc.

Role: CONTACT

+91 9881133834

Facility Contacts

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Nitin Vanjare, M.Sc.

Role: primary

+91 9970537116

Shweta Rasam, B.Sc.

Role: backup

+91 9881133834

References

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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.

Reference Type BACKGROUND
PMID: 19249998 (View on PubMed)

Kaminsky 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.

Reference Type BACKGROUND
PMID: 28714735 (View on PubMed)

Liu 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.

Reference Type RESULT
PMID: 24977005 (View on PubMed)

Other Identifiers

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CRF/01/2017

Identifier Type: -

Identifier Source: org_study_id

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