Effects of Yoga on Clinical Impact and Psychosocial Aspects of COPD
Condition: Chronic Pulmonary Obstructive Disease
Study type: Interventional

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.
    

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.
    

Intervention name(s): Yoga bhastrika pranayama breathing exercise; Pulmonary Rehabilitation
Intervention type(s): Other; Other
Intervention description(s): 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 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: clinical impact; anxiety; quality of life; Yoga