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CTRI Number  CTRI/2024/12/078027 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 09/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of yoga breathing and pulmonary rehabilitation in AECOPD patients. 
Scientific Title of Study   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. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivam Varfa 
Designation  Ph.D. Scholar 
Affiliation  All India Institute of Medical Science Rishikesh 
Address  Shivam Varfa, Ph.D. Scholar, Floor 6, Dept. of Pulmonary medicine, AIIMS Rishikesh - 249203 (Contact No. 8224967331)

Dehradun
UTTARANCHAL
249203
India 
Phone  8224967331  
Fax    
Email  shivamvarfa1619@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ruchi Dua 
Designation  Additional Professor 
Affiliation  AIIMS Rishikesh 
Address  Dr Ruchi Dua, Additional professor, Floor 6, Dept. of Pulmonary medicine, AIIMS Rishikesh - 249203 (Contact No. 7895973469)

Dehradun
UTTARANCHAL
249203
India 
Phone  7895973469  
Fax    
Email  Ruchi.pulm@aiimsrishikesh.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Ruchi Dua 
Designation  Additional Professor 
Affiliation  AIIMS Rishikesh 
Address  Dr Ruchi Dua, Additional professor, Floor 6, Dept. of Pulmonary medicine, AIIMS Rishikesh - 249203 (Contact No. 7895973469)

Dehradun
UTTARANCHAL
249203
India 
Phone  7895973469  
Fax    
Email  Ruchi.pulm@aiimsrishikesh.edu.in  
 
Source of Monetary or Material Support  
This study will be conducted at AIIMS, Rishikesh. The study will take the infrastructural support from AIIMS. The study has not received any funding from external sources. 
 
Primary Sponsor  
Name  AIIMS Rishikesh 
Address  All India Institute of Medical Sciences Virbhadra Road Rishikesh Uttarakhand 249203 India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ruchi Dua  AIIMS RISHIKESH  Pulmonary medicine ward, level 5, All India Institute of Medical Science, Virbhadra Road, Rishikesh, Uttarakhand 249203. India.
Dehradun
UTTARANCHAL 		 7895973469

Ruchi.pulm@aiimsrishikesh.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pulmonary Rehabilitation (PR)  Pulmonary rehabilitation for Control Group Module, A structured 30-minute pulmonary rehabilitation program. The session begins with a 5-minute warm-up, followed by 25 minutes of progressive upper and lower limb exercises, including sit-to-stand, biceps curl with shoulder press, step-up, bent-over rowing, static-dynamic squat, and front raise with dumbbells or a water bottle. Accessories such as dumbbells, water bottles, chairs, or step boxes are utilised to enhance the exercises. The same PR module is applied to both groups to ensure consistency. Additionally, the module includes patient education program on managing COPD at home, focusing on treatment basics, exacerbation signs, medication use, physical activity, nutrition, smoking cessation, and relaxation techniques.  
Intervention  Yoga-based breathing and Pulmonary rehabilitation  The total duration of the intervention is 45 minutes, structured to incorporate a combination of warm-up exercises, physical activity, and yoga-based breathing practices. The session begins with a 5-minute warm-up to prepare the body and mind. This is followed by upper and lower limb exercises lasting 25 minutes, focusing on strength and endurance using accessories such as dumbbells, water bottles, or a stepbox as required. The final 15 minutes are dedicated to yoga-based breathing exercises and specific pranayama techniques. Additionally, the module includes a patient education program on managing COPD at home, focusing on treatment basics, exacerbation signs, medication use, physical activity, nutrition, smoking cessation, and relaxation techniques. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Inclusion Criteria
1) Both genders of age range 40-75 years old.
2) Individuals admitted with the diagnosis of AECOPD.
3) Individuals should be able to perform spirometry, MIP/MEP, and 6MWD.
4) Consenting
 
 
ExclusionCriteria 
Details  Exclusion criteria
1) Muscular/neurological/neuromuscular disease
2) Unable to perform rehabilitation/yoga
3) Patients or caretakers do not have access to smart phones
4) Uncontrolled DM/severe co-morbidities (IHD/CKD/CLD), arrhythmia, severe hypertension, acute pulmonary embolism, any known malignancy with a short life expectancy, and acute heart failure.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome for this trial will be the change in respiratory muscle strength including Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) among AECOPD patients.  outcomes will be recorded on baseline and 8 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes for this study will be following:
1. Symptom score - mMRC Dyspnea, BORG Scale
2. GAD-7 for Generalized Anxiety Disorder
3. Patient Health Questionnaire (PHQ-9) for Depression
4. Health-related quality of life (SGRQ)
5. Partial pressure of Carbon dioxide (PCO2)
6. C-Reactive Protein (CRP)
7. Spirometry Variables: FEV1%, FVC, FEV1/FVC
8. 6-minute walk distance (6MWD) with BORG scale
9. Adverse Events (Deaths, emergency visits, readmission rate)
 		 8 weeks 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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