Chronic Pulmonary Obstructive Disease Clinical Trial
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01449175 -
A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema
|
N/A |