NCT04020081

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

1.8 years

First QC Date

June 3, 2019

Last Update Submit

July 11, 2019

Conditions

COPDObstructive Pulmonary Disease

Keywords

YogaMeditationCOPDLung function

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • RV/TLC in%

    3 Months

  • TLC in liters

    3 Months

  • Respiratory impedance in kpa/(L/s)

    3 Months

Study Arms (2)

Effect of yoga exercises in COPD patients after 12 weeks.

EXPERIMENTAL

Yoga group

Other: Yoga breathing exercises and Meditation

COPD patients lung functions without yoga excercises.

NO INTERVENTION

Control group

Interventions

Yoga breathing exercises and MeditationOTHER

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.

Effect of yoga exercises in COPD patients after 12 weeks.

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chest Research Foundation

Pune, Maharashtra, 411014, India

RECRUITING

Related 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.

    PMID: 19249998BACKGROUND

  • 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.

    PMID: 28714735BACKGROUND

  • 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.

    PMID: 24977005RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases, Obstructive

Interventions

Meditation

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Dr. Sundeep Salvi, MD

    Director

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitin Vanjare, M.Sc.

CONTACT

+91 9970537116vanjarenitin@crfindia.com

Shweta Rasam, B.Sc.

CONTACT

+91 9881133834shweta@crfindia.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 3, 2019

First Posted

July 15, 2019

Study Start

March 9, 2018

Primary Completion

December 20, 2019

Study Completion

January 1, 2020

Last Updated

July 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)