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CTRI Number  CTRI/2025/02/080473 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On: 11/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Yoga on Respiratory Function and Well-being of Patients with Chronic Lung Disease 
Scientific Title of Study   Efficacy of Integrated Yoga as an Adjuvant Therapy on Lung Function and Health-related Quality of Life in Chronic Obstructive Pulmonary Disease Patients - 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  Nikhil S 
Designation  Ph.D. Scholar  
Affiliation  Sri Devaraj Urs Academy of Higher Education and Research 
Address  Department of integrative medicine, Sri Devaraj Urs Academy of Higher Education and Research Kolar, Karnataka

Kolar
KARNATAKA
563103
India 
Phone  8970535845  
Fax    
Email  nikhilsrinivasgowda@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Usha G Shenoy 
Designation  Assistant Professor 
Affiliation  Sri Devaraj Urs Academy of Higher Education and Research 
Address  2nd floor, Faculty of Allied Health & Basic Sciences, PG block, Sri Devaraj Urs Academy of Higher Education and Research Kolar, Karnataka

Kolar
KARNATAKA
563103
India 
Phone  9880633910  
Fax    
Email  ushagshenoy@sduaher.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Usha G Shenoy 
Designation  Assistant Professor 
Affiliation  Sri Devaraj Urs Academy of Higher Education and Research 
Address  2nd floor, Faculty of Allied Health & Basic Sciences, PG block, Sri Devaraj Urs Academy of Higher Education and Research Kolar, Karnataka

Kolar
KARNATAKA
563103
India 
Phone  9880633910  
Fax    
Email  ushagshenoy@sduaher.ac.in  
 
Source of Monetary or Material Support  
Sri Devaraj Urs Academy of Higher Education and Research Kolar-563103, Karnataka, India 
 
Primary Sponsor  
Name  Nikhil S 
Address  Department of integrative medicine, Sri Devaraj Urs Academy of Higher Education and Research, tamaka, Kola, Karnataka-563103 
Type of Sponsor  Other [Self ] 
 
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 
Nikhil S  RL Jalappa Hospital and Research Center  Department of integrative medicen, Sri Devaraj Urs Academy of Higher Education and Research Kolar, Karnataka
Kolar
KARNATAKA 
08970535845

nikhilsrinivasgowda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Integrated yoga module   Integrated Yoga will be given to the intervention group- each session will be of one hour. The intervention group will attend sessions five times a week for six weeks. 
Comparator Agent  Standard care for COPD   Patents in the control group will under go standard care treatment only. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Individuals diagnosed with mild and moderate COPD (GOLD).
2. Undergoing standard care.
3. Age ranges from 30 to 60 years.
4. Both genders
5. Who has given consent 
 
ExclusionCriteria 
Details  1. Participants with a history of substance abuse, psychotic illnesses, and those on therapy for psychotic illness.
3. Other chronic conditions such as recent/history of stroke, post coronary artery bypass grafting, morbid obesity, uncontrolled diabetes, and uncontrolled hypertension and lung cancer.
4. Recent fractures / recent surgery, severe knee joint pain/ osteoarthritis will be excluded from the study.
5. Participants who have been exposed to Yoga practice in the last 3 months 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Pulmonary function test (Spirometry test)
2. Functional capacity: 6-minute walk test
3. Dyspnoea -Modified Borg scale 
Baseline data will be collected at first day and at end of sixth week. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Health-related QOL- SGRQ-C (Saint George Respiratory Questionnaire-C)
2.Digit Vigilance Test (DVT)
 
Baseline data will be collected at first day and at end of sixth week. 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   24/02/2025 
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="1"
Months="6"
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  

Chronic Obstructive Pulmonary Disease (COPD) is a common lung disease that causes restricted airflow and breathing problems. It is a non-communicable disease affecting 300 million people globally, which is 10.3% of the population. According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD, India has 55.3 million cases of COPD. The Symptoms include difficulty in breathing, persistent cough, and mucus production, there is also abstracted attention and delayed recall in COPD patients, especially in the exacerbation group where there is cognitive alternation.  Cognitive impairment has been demonstrated in 77% of patients with COPD, Additionally, difficulty in performing instrumental activities of daily living due to COPD is associated with cognitive deficits. Despite the high prevalence, the awareness level in India is low, emphasizing the need for education and proactive strategies to mitigate the disease’s impact. Comprehensive management of COPD includes standard preventive measures like bronchodilators such as beta-2 agonist inhalers such as salbutamol, formoterol and terbutaline, antimuscarinic inhalers such as ipratropium, tiotropium and glycopyronnium. Anti-inflammatories, regular exercise, and pulmonary rehabilitation are also important, along with standard care treatment for COPD. A comprehensive yoga program, including physical postures, breathing exercises, and meditation may improve Forced expiratory volume (FEV1), Forced vital capacity (FVC), Peak expiratory flow rate (PEFR), and FEV1/FVC ratio. Specific yogic Breathing techniques showed a significant positive impact on pulmonary functions. Studies show yoga’s holistic benefits to improve health-related quality of life (HRQoL) in various populations, including patients with chronic illnesses like Diabetes Mellitus, asthma, Myocardial Infarction (MI), and cancer.
Lacuna in Knowledge: The efficacy of yoga as a complementary intervention for respiratory disorders and obstructive breathing has been explored by many studies. Therapies used for COPD studies differ significantly in terms of their practices and, only a few studies have explored the potential benefits of various yogic tools on lung parameters and overall health-related quality in COPD patients. COPD is a multi-component disease, but little attention has been paid to its effects on cognitive function, and studies suggest that cognitive function should be screened in people with COPD, due to a lack of attention and vigilance   in determining the cognitive domain that has been affected. The strength of these findings remains uncertain due to a lack of substantial evidence. The integration of yoga into COPD is a long-conventional treatment that poses a significant challenge for researchers, and also Additionally, the socio-economic burden on patients to access standard treatments is substantial. Recognizing yoga as a cost-effective, safe, and holistic approach, there are limited studies available in the Tertiary Care population. Hence our study aims to determine the mechanisms underlying yoga-based comprehensive therapy.  This study intends to assess the effects of yoga on pulmonary functions, health-related quality-of-life outcomes, and cognitive function, ultimately providing more effective and accessible interventions for COPD and other respiratory conditions.

 
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