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

Not Applicable

• Conditions: Obstructive Pulmonary Disease; COPD
• Interventions: Other: Yoga breathing exercises and Meditation

• Registration Number: NCT04020081
• Lead Sponsor: Chest Research Foundation, India

Brief 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.

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 Timeline

• Study Start: 2018-03-09
• Study First Submitted: 2019-06-03
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-11
• Last Update Submitted: 2019-07-11
• Study First Posted: 2019-07-15
• Last Update Posted: 2019-07-15
• Primary Completion: 2019-12-20
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Effect of yoga exercises in COPD patients after 12 weeks.	Yoga breathing exercises and Meditation	Yoga group

Primary Outcome Measures

Name	Time	Method
St.George's Respiratory Questionnaires (SGRQ) score for quality of life in numbers.	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.	3 Months.	Effect of Yoga Exercises and Meditation on 6 minute walk distance (6 MWD) after 12 week in COPD patients.

Secondary Outcome Measures

Name	Time	Method
RV/TLC in%	3 Months	Effect of Yoga Exercises and Meditation on lung function after 12 week in COPD patients.
TLC in liters	3 Months	Effect of Yoga Exercises and Meditation on lung function after 12 week in COPD patients.
Respiratory impedance in kpa/(L/s)	3 Months	Effect of Yoga Exercises and Meditation on lung function after 12 week in COPD patients.

Trial Locations

Locations (1)

Chest Research Foundation; 🇮🇳 Pune, Maharashtra, India