NCT02539524

Brief Summary

The aim of this study is to investigate weather the breathing exercises of Yoga are effective in altering clinical impact, anxiety, depression and quality of life in Chronic Obstructive Pulmonary Disease patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

10 months

First QC Date

August 28, 2015

Last Update Submit

September 12, 2016

Conditions

Keywords

clinical impactanxietyquality of lifeYoga

Outcome Measures

Primary Outcomes (1)

  • Changes in COPD Clinical Impact

    Evaluated by COPD Assessment Test Questionnaire

    Baseline and 12 weeks

Secondary Outcomes (2)

  • Changes in Anxiety and Depression Scale

    Baseline and 12 weeks

  • Changes in Quality of Life Questionnaire

    Baseline and 12 weeks

Study Arms (2)

Pulmonary Rehabilitation Group

ACTIVE COMPARATOR

Pulmonary Rehabilitation Group Intervention consisted of 12-week pulmonary rehabilitation. Two 1 hour sessions a week, consisting of: 30 min of aerobic training followed by resistance exercises for upper and lower limbs.

Other: Pulmonary Rehabilitation

Yoga Group

EXPERIMENTAL

Yoga Bhastrika Pranayama breathing exercises consisted of: 12-week pulmonary rehabilitation (two 1 hour sessions a week, consisting of: 30 min of aerobic training followed by resistance exercises for upper and lower limbs). After each pulmonary rehabilitation session, participants of this group performed 10 bhastrika pranayama breathing exercises (1 bhastrika is formed by 20 kapalabhati followed by 1 surya bedhana - described earlier).

Other: Yoga bhastrika pranayama breathing exercise

Interventions

Bhastrika Pranayama is formed by a set of 20 nasal forced and rapid expirations, followed by passive nasal inspirations, followed by 1 alternate nasal breath which always begins through the right nostril, and has a retention between intake and outflow. The set of this breathing exercise is supposed to bring respiratory relief.

Yoga Group

Pulmonary Rehabilitation Group Intervention consisted of 12-week pulmonary rehabilitation. Two 1 hour sessions a week, consisting of: 30 min of aerobic training followed by resistance exercises for upper and lower limbs.

Pulmonary Rehabilitation Group

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD diagnosed classified as B, C or D according to the Global Initiative for Obstructive Lung Disease (GOLD);
  • Optimized medical treatment.

You may not qualify if:

  • Any other lung disease;
  • Home use of oxygen therapy;
  • Respiratory Yoga exercise training in the last 2 years;
  • Current smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary and Rehabilitation Ambulatory of the Clinical Hospital of the University of São Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (5)

  • Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.

    PMID: 17507545BACKGROUND
  • 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
  • Brown RP, Gerbarg PL. Sudarshan Kriya yogic breathing in the treatment of stress, anxiety, and depression: part I-neurophysiologic model. J Altern Complement Med. 2005 Feb;11(1):189-201. doi: 10.1089/acm.2005.11.189.

    PMID: 15750381BACKGROUND
  • Pomidori L, Campigotto F, Amatya TM, Bernardi L, Cogo A. Efficacy and tolerability of yoga breathing in patients with chronic obstructive pulmonary disease: a pilot study. J Cardiopulm Rehabil Prev. 2009 Mar-Apr;29(2):133-7. doi: 10.1097/HCR.0b013e31819a0227.

    PMID: 19305239BACKGROUND
  • Santaella DF, Devesa CR, Rojo MR, Amato MB, Drager LF, Casali KR, Montano N, Lorenzi-Filho G. Yoga respiratory training improves respiratory function and cardiac sympathovagal balance in elderly subjects: a randomised controlled trial. BMJ Open. 2011 May 24;1(1):e000085. doi: 10.1136/bmjopen-2011-000085.

    PMID: 22021757BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAnxiety Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Celso RF Carvalho, Ph.D.

    University of Sao Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

August 28, 2015

First Posted

September 3, 2015

Study Start

January 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

September 14, 2016

Record last verified: 2016-09

Locations