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

July 11, 2019 updated by: Dr.Sundeep S Salvi, Chest Research Foundation, India

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Maharashtra
      • Pune, Maharashtra, India, 411014
        • Recruiting
        • Chest Research Foundation
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr. Sundeep Salvi, MD
        • Principal Investigator:
          • Dr.Alpa Dalal, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Effect of yoga exercises in COPD patients after 12 weeks.
Yoga group
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.
No Intervention: COPD patients lung functions without yoga excercises.
Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
St.George's Respiratory Questionnaires (SGRQ) score for quality of life in numbers.
Time Frame: 3 Months
Effect of Yoga Exercises and Meditation on SGRQ score after 12 week in COPD patients.
3 Months
Exercise capacity 6 minute walk distance (6MWD) in meter.
Time Frame: 3 Months.
Effect of Yoga Exercises and Meditation on 6 minute walk distance (6 MWD) after 12 week in COPD patients.
3 Months.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chest Research Foundation, India

Collaborators

Jupiter Hospital, India

Investigators

  • Principal Investigator: Dr. Sundeep Salvi, MD, Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2018

Primary Completion (Anticipated)

December 20, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

June 3, 2019

First Submitted That Met QC Criteria

July 11, 2019

First Posted (Actual)

July 15, 2019

Study Record Updates

Last Update Posted (Actual)

July 15, 2019

Last Update Submitted That Met QC Criteria

July 11, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRF/01/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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