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

Primary Purpose

COPD, Obstructive Pulmonary Disease

Status

Unknown status

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Yoga breathing exercises and Meditation

About this trial

This is an interventional treatment trial for COPD focused on measuring Yoga, Meditation, COPD, Lung function

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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).
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:
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.

Sites / Locations

Chest Research FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Effect of yoga exercises in COPD patients after 12 weeks.

COPD patients lung functions without yoga excercises.

Arm Description

Yoga group

Control group

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

RV/TLC in%

Effect of Yoga Exercises and Meditation on lung function after 12 week in COPD patients.

TLC in liters

Effect of Yoga Exercises and Meditation on lung function after 12 week in COPD patients.

Respiratory impedance in kpa/(L/s)

Effect of Yoga Exercises and Meditation on lung function after 12 week in COPD patients.

Full Information

NCT ID

NCT04020081

First Posted

June 3, 2019

Last Updated

July 11, 2019

Sponsor

Chest Research Foundation, India

Collaborators

Jupiter Hospital, India

1. Study Identification

Unique Protocol Identification Number

NCT04020081

Brief Title

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

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 9, 2018 (Actual)

Primary Completion Date

December 20, 2019 (Anticipated)

Study Completion Date

January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chest Research Foundation, India

Collaborators

Jupiter Hospital, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD, Obstructive Pulmonary Disease

Keywords

Yoga, Meditation, COPD, Lung function

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Effect of yoga exercises in COPD patients after 12 weeks.

Arm Type

Experimental

Arm Description

Yoga group

Arm Title

COPD patients lung functions without yoga excercises.

Arm Type

No Intervention

Arm Description

Control group

Intervention Type

Other

Intervention Name(s)

Yoga breathing exercises and Meditation

Intervention Description

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.

Primary Outcome Measure Information:

Title

St.George's Respiratory Questionnaires (SGRQ) score for quality of life in numbers.

Description

Effect of Yoga Exercises and Meditation on SGRQ score after 12 week in COPD patients.

Time Frame

3 Months

Title

Exercise capacity 6 minute walk distance (6MWD) in meter.

Description

Effect of Yoga Exercises and Meditation on 6 minute walk distance (6 MWD) after 12 week in COPD patients.

Time Frame

3 Months.

Secondary Outcome Measure Information:

Title

RV/TLC in%

Description

Effect of Yoga Exercises and Meditation on lung function after 12 week in COPD patients.

Time Frame

3 Months

Title

TLC in liters

Description

Effect of Yoga Exercises and Meditation on lung function after 12 week in COPD patients.

Time Frame

3 Months

Title

Respiratory impedance in kpa/(L/s)

Description

Effect of Yoga Exercises and Meditation on lung function after 12 week in COPD patients.

Time Frame

3 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nitin Vanjare, M.Sc.

Phone

+91 9970537116

vanjarenitin@crfindia.com

First Name & Middle Initial & Last Name or Official Title & Degree

Shweta Rasam, B.Sc.

Phone

+91 9881133834

shweta@crfindia.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Sundeep Salvi, MD

Organizational Affiliation

Director

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chest Research Foundation

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411014

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nitin Vanjare, M.Sc.

Phone

+91 9970537116

vanjarenitin@crfindia.com

First Name & Middle Initial & Last Name & Degree

Shweta Rasam, B.Sc.

Phone

+91 9881133834

shweta@crfindia.com

First Name & Middle Initial & Last Name & Degree

Dr. Sundeep Salvi, MD

First Name & Middle Initial & Last Name & Degree

Dr.Alpa Dalal, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19249998

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.

Results Reference

background

PubMed Identifier

28714735

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.

Results Reference

background

PubMed Identifier

24977005

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.

Results Reference

result

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

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