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

COPD Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04020081
• Other study ID #: CRF/01/2017
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2018
• Est. completion date: January 2020

Study information

• Verified date: July 2019
• Source: Chest Research Foundation, India
• Contact: Nitin Vanjare, M.Sc.
• Phone: +91 9970537116
• Email: vanjarenitin[@]crfindia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Obstructive Pulmonary Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 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.

Locations

Country	Name	City	State
India	Chest Research Foundation	Pune	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
Chest Research Foundation, India	Jupiter Hospital, India

Country where clinical trial is conducted

India, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 Months
Primary	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.	3 Months.
Secondary	RV/TLC in%	Effect of Yoga Exercises and Meditation on lung function after 12 week in COPD patients.	3 Months
Secondary	TLC in liters	Effect of Yoga Exercises and Meditation on lung function after 12 week in COPD patients.	3 Months
Secondary	Respiratory impedance in kpa/(L/s)	Effect of Yoga Exercises and Meditation on lung function after 12 week in COPD patients.	3 Months