| 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
|
|
|
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
|
|
|
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. |