Efficacy of Yoga based Breathing and Pulmonary Rehabilitation versus Pulmonary Rehabilitation alone on Respiratory Muscle Strength in Patients of Acute Exacerbation of COPD - A Randomized Controlled Trial.

Background: Chronic obstructive pulmonary disease (COPD) is a progressive condition characterized by airflow limitation in the respiratory airways, worsening during acute exacerbations. Pulmonary rehabilitation (PR) is a key treatment for AECOPD. Despite its proven benefits, conventional PR remains underutilized, with fewer than 5% of eligible COPD patients receiving it. In addition to PR, yoga—a mind-body approach—has been shown to improve lung function, psychological parameters, and quality of life in COPD patients. Yoga breathing exercises are recommended by ATS guidelines in PR for COPD treatment, yet they remain underutilized in practice due to a lack of trials.

Aim: This trial aims to compare the effect of home-based yoga breathing combined with PR versus PR alone on clinical, inflammatory markers and pulmonary function test among AECOPD patients over a period of eight weeks.

Methods: This trial is a prospective, randomized controlled trial with two parallel arms. It includes consenting AECOPD patients aged 40-75 who can perform maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), and the Six-Minute Walk Distance (6MWD) test. Exclusion criteria include neuromuscular disorders, inability to perform the intervention, lack of smartphone access, uncontrolled diabetes, severe comorbidities, arrhythmia, severe hypertension, pulmonary embolism, malignancy, limited life expectancy, or heart failure. Based on sample size calculations, 150 hospitalized AECOPD patients will be eligible to participate. All participants will be randomized by block randomization (computer generated sequence) in allocated ratio of 1:1 among both groups by sequentially numbered opaque sealed envelope. The intervention group will receive home-based yoga breathing combined with PR for 45 minutes, three times per week, over 8 weeks via an online platform. The control group will receive Home-based Tele-PR alone for 30 minutes over the same duration.

Outcome: The primary outcome is the change in Respiratory Muscle Strength (RMS), including MIP and MEP, after 8 weeks. Secondary outcomes include changes in the modified Medical Research Council Dyspnea Scale, Forced Expiratory Volume in one second, Depression and Anxiety scores, St. George’s Respiratory Questionnaire scores, PCO2 levels, inflammatory markers (including CRP), Exercise Capacity (6MWD), and rates of readmission and emergency visits. These measures will be assessed at baseline and after 8 weeks of follow-up.

Analysis: Data normality will be assessed using the Shapiro-Wilk test. Based on this, MIP and MEP changes will be analyzed with independent t-tests or Mann-Whitney U tests as appropriate. Other quantitative outcomes will be analyzed with t-tests, and qualitative outcomes with chi-square tests. A significance level of p < 0.05 and a 95% confidence interval will be applied. Analysis will follow an intention-to-treat approach.

Discussion: This trial is expected to provide valuable insights into the efficacy of combining yoga-based breathing with PR to improve RMS  among AECOPD patients, compared to PR alone.