Clinical trial NCT04020081: A Study to Evaluate the Effect of Yoga Exercises and Meditation on Lung Function and Quality of Life in COPD Patients.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Obstructive Pulmonary Disease
Keywords: Yoga
Meditation
COPD
Lung function
Lead sponsor: Chest Research Foundation, India
Sponsor class: OTHER
Collaborators: name: Jupiter Hospital, India
First posted: 2019-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: St.George's Respiratory Questionnaires (SGRQ) score for quality of life in numbers.
timeFrame: 3 Months
measure: Exercise capacity 6 minute walk distance (6MWD) in meter.
timeFrame: 3 Months.
Secondary outcomes:
measure: RV/TLC in%
timeFrame: 3 Months
measure: TLC in liters
timeFrame: 3 Months
measure: Respiratory impedance in kpa/(L/s)
timeFrame: 3 Months
Other outcomes:
Locations:
city: Pune
country: India
facility: Chest Research Foundation
state: Maharashtra
Study officials:
affiliation: Director
name: Dr. Sundeep Salvi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.