Chronic Pulmonary Obstructive DiseaseNCT02539524
Effects of Yoga on Clinical Impact and Psychosocial Aspects of COPD
A study testing Yoga bhastrika pranayama breathing exercise and Pulmonary Rehabilitation in people with Chronic Pulmonary Obstructive Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Chronic Pulmonary Obstructive Disease
- What is being tested?
- Yoga bhastrika pranayama breathing exercise and Pulmonary Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD diagnosed classified as B, C or D according to the Global Initiative for Obstructive Lung Disease (GOLD);
- Optimized medical treatment.
Who cannot join
- Any other lung disease;
- Home use of oxygen therapy;
- Respiratory Yoga exercise training in the last 2 years;
- Current smokers.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Pulmonary and Rehabilitation Ambulatory of the Clinical Hospital of the University of São Paulo
São Paulo, São Paulo, 05403-000
About this study
Official title: Effects of Yoga Respiratory Exercises on Clinical Impact, and Psychosocial Aspects in Patients With Chronic Obstructive Pulmonary Disease
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.
Read the detailed description
Introduction According to the Global Initiative for Chronic Lung Disease (GOLD), chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease, characterized by a persistent not totally reversible limitation of air flow, with a progressively characteristic associated to the increase of inflammatory lungs and air pathways reactions to gas and harmful particles. It is one of the main morbid-mortality causes world wide and, thus, a social health matter. Dyspnoea is a recurrent stressful symptom of COPD, and is usually followed by anxiety, depression, and decreased quality of life.
Some studies have addressed the tolerance of yoga breathing exercises by COPD patients, and some have indeed found a decreased functional load of dyspnoea in such patients.
Thus, the aim of this study is to investigate the effects of the regular practice (training) of respiratory Yoga exercises (pranayamas) on the clinical impact and psychosocial aspects: anxiety, depression and quality of life in COPD patients as a complementary therapy to pulmonary rehabilitation.
Methods Participants Diagnosed COPD patients will be recruited from the Pulmonary Rehabilitation Ambulatory of the Clinical Hospital of the Faculty of Medicine of the University of São Paulo (HC-FMUSP). All participants will give written consent to participate of the study, and will be able to exit the study at any point without having to explain the reason.
Sample Size Calculation Based on effect expected proportion in controls of 0.05, assuming an odds ratio of 25, in a confidence level of 0.95, and a power of 0.8, the sample size for each group was 9, in a total sample size (both groups) of 18 participants.
Experimental Design This is a randomized controlled prospective clinical trial, with two groups: pulmonary rehabilitation for control group (PRG) and pulmonary rehabilitation plus Yoga group (YG).Randomization was carried out by numbered paper draw: 20 papers numbered from 1-20 were put in a bag from which participants took 1 paper each. Even numbers indicated PRG and odd ones indicated YG. Medication will not altered during study. Both groups will perform a 12-week pulmonary rehabilitation program, besides that, YG will perform 24 Yoga breathing sessions (2 times a week). Participants of both groups will answer questionnaires to evaluate clinical impact, anxiety, depression and quality of life at study entry and after 12 weeks.
Yoga Breathing Exercises Breathing exercises will be based on traditional Hatha Yoga texts (Hathapradipika and Gheranda Samhita). The chosen exercise was bhastrika pranayama (kapalabhati followed by surya bedhana). Kapalabhhati consists basically of 20 fast and vigorous abdominal contractions for expiration, followed by immediate and maximal relaxation of these muscles for inspiration, and surya bedhana is a slow inspiration through the right nostril, followed by a comfortable apnoea for the same time of air intake, and a slower yet comfortable expiration through the left nostril. During training, participants will be considered at peak training when they are able to perform 10 sets of bhastrika.
Pulmonary Rehabilitation will consist of 30 minutes of aerobic training (cycloergometer or treadmill) followed by resistance exercises for lower and upper limbs.
Evaluations Clinical impact of COPD will be accessed by the COPD Assessment Test; anxiety will be evaluated by Hospital Anxiety and Depression Scale; Quality of Life will be accessed by the self-reported Chronic Respiratory Questionnaire.
Statistical Analysis Intra-group comparisons between moments (pre vs. post treatment) will be done using a paired Student T-test (repeated measures). While inter-groups comparisons (PRG vs. YG) will be done using the independent measures Student T-test. Significance will be accepted when p<0.05. SPSS v.21 software will be used to process analysis.
- Conditions
- Chronic Pulmonary Obstructive Disease
- Being tested
- Yoga bhastrika pranayama breathing exercise, Pulmonary Rehabilitation
- Keywords
- clinical impact, anxiety, quality of life, Yoga
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga bhastrika pranayama breathing exerciseOther
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.
Pulmonary RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Yoga bhastrika pranayama breathing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in COPD Clinical Impact
Evaluated by COPD Assessment Test Questionnaire
Measured: Baseline and 12 weeks
Secondary outcomes (2)
Changes in Anxiety and Depression Scale
Evaluated by Hospital Anxiety and Depression Scale
Measured: Baseline and 12 weeks
Changes in Quality of Life Questionnaire
Evaluated by self-reported Chronic Respiratory Questionnaire
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Pulmonary Obstructive DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danilo Forghieri Santaella, University of Sao Paulo
- Investigators
- Celso RF Carvalho, Ph.D., Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539524
- Sponsor's protocol ID
- 102838/2014
- Status last verified
- Sep 2016
- First submitted
- 28 Aug 2015
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17507545Donesky-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.
PubMed 19249998Brown 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.
PubMed 15750381Pomidori 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.
PubMed 19305239Santaella 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.
PubMed 22021757
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yoga Respiratory Exercises on Clinical Impact, and Psychosocial Aspects in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02539524
- Acronym / sponsor ID
- 102838/2014
- Conditions
- Chronic Pulmonary Obstructive Disease
- Keywords
- clinical impact, anxiety, quality of life, Yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction According to the Global Initiative for Chronic Lung Disease (GOLD), chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease, characterized by a persistent not totally reversible limitation of air flow, with a progressively characteristic associated to the increase of inflammatory lungs and air pathways reactions to gas and harmful particles. It is one of the main morbid-mortality causes world wide and, thus, a social health matter. Dyspnoea is a recurrent stressful symptom of COPD, and is usually followed by anxiety, depression, and decreased quality of life.
Some studies have addressed the tolerance of yoga breathing exercises by COPD patients, and some have indeed found a decreased functional load of dyspnoea in such patients.
Thus, the aim of this study is to investigate the effects of the regular practice (training) of respiratory Yoga exercises (pranayamas) on the clinical impact and psychosocial aspects: anxiety, depression and quality of life in COPD patients as a complementary therapy to pulmonary rehabilitation.
Methods Participants Diagnosed COPD patients will be recruited from the Pulmonary Rehabilitation Ambulatory of the Clinical Hospital of the Faculty of Medicine of the University of São Paulo (HC-FMUSP). All participants will give written consent to participate of the study, and will be able to exit the study at any point without having to explain the reason.
Sample Size Calculation Based on effect expected proportion in controls of 0.05, assuming an odds ratio of 25, in a confidence level of 0.95, and a power of 0.8, the sample size for each group was 9, in a total sample size (both groups) of 18 participants.
Experimental Design This is a randomized controlled prospective clinical trial, with two groups: pulmonary rehabilitation for control group (PRG) and pulmonary rehabilitation plus Yoga group (YG).Randomization was carried out by numbered paper draw: 20 papers numbered from 1-20 were put in a bag from which participants took 1 paper each. Even numbers indicated PRG and odd ones indicated YG. Medication will not altered during study. Both groups will perform a 12-week pulmonary rehabilitation program, besides that, YG will perform 24 Yoga breathing sessions (2 times a week). Participants of both groups will answer questionnaires to evaluate clinical impact, anxiety, depression and quality of life at study entry and after 12 weeks.
Yoga Breathing Exercises Breathing exercises will be based on traditional Hatha Yoga texts (Hathapradipika and Gheranda Samhita). The chosen exercise was bhastrika pranayama (kapalabhati followed by surya bedhana). Kapalabhhati consists basically of 20 fast and vigorous abdominal contractions for expiration, followed by immediate and maximal relaxation of these muscles for inspiration, and surya bedhana is a slow inspiration through the right nostril, followed by a comfortable apnoea for the same time of air intake, and a slower yet comfortable expiration through the left nostril. During training, participants will be considered at peak training when they are able to perform 10 sets of bhastrika.
Pulmonary Rehabilitation will consist of 30 minutes of aerobic training (cycloergometer or treadmill) followed by resistance exercises for lower and upper limbs.
Evaluations Clinical impact of COPD will be accessed by the COPD Assessment Test; anxiety will be evaluated by Hospital Anxiety and Depression Scale; Quality of Life will be accessed by the self-reported Chronic Respiratory Questionnaire.
Statistical Analysis Intra-group comparisons between moments (pre vs. post treatment) will be done using a paired Student T-test (repeated measures). While inter-groups comparisons (PRG vs. YG) will be done using the independent measures Student T-test. Significance will be accepted when p<0.05. SPSS v.21 software will be used to process analysis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Rehabilitation Group | Active comparator | Other: Pulmonary RehabilitationPulmonary 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. |
| Yoga Group | Experimental | Other: Yoga bhastrika pranayama breathing exerciseYoga 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). |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD diagnosed classified as B, C or D according to the Global Initiative for Obstructive Lung Disease (GOLD);
- Optimized medical treatment.
Key exclusion criteria (4 listed)
- Any other lung disease;
- Home use of oxygen therapy;
- Respiratory Yoga exercise training in the last 2 years;
- Current smokers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga bhastrika pranayama breathing exerciseBhastrika 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. | Other | Yoga Group |
| Pulmonary RehabilitationPulmonary 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 Group |
Primary outcome
Changes in COPD Clinical Impact
Time frame: Baseline and 12 weeks
Evaluated by COPD Assessment Test Questionnaire
2 secondary outcomes
Changes in Anxiety and Depression Scale
Time frame: Baseline and 12 weeks
Changes in Quality of Life Questionnaire
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Background: PubMed 17507545Rabe 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.
- Background: PubMed 19249998Donesky-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.
- Background: PubMed 15750381Brown 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.
- Background: PubMed 19305239Pomidori 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.
- Background: PubMed 22021757Santaella 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celso RF Carvalho, Ph.D. study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga bhastrika pranayama breathing exercise and Pulmonary Rehabilitation in people with Chronic Pulmonary Obstructive Disease, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in COPD Clinical Impact (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02539524, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2016.