| CTRI Number |
CTRI/2026/02/102813 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of yoga combined with usual rehabilitation exercises in improving exercise capacity in patients of COPD |
|
Scientific Title of Study
|
Efficacy of Pulmonary Rehabilitation Augmented by Yoga on Exercise Capacity and Quality of Life in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease: A Randomised Controlled Trial |
| Trial Acronym |
PRAYOGIC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pawan Tiwari |
| Designation |
Assistant Professor Pulmonary Critical Care and Sleep Medicine |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Third Floor, New Private Ward, Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
01126593676 |
| Fax |
|
| Email |
pavan14281@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pawan Tiwari |
| Designation |
Assistant Professor Pulmonary Critical Care and Sleep Medicine |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Third Floor, New Private Ward, Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences, Ansari Nagar East, New Delhi
DELHI
110029
India |
| Phone |
01126593676 |
| Fax |
|
| Email |
pavan14281@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pawan Tiwari |
| Designation |
Assistant Professor Pulmonary Critical Care and Sleep Medicine |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Third Floor, New Private Ward, Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences, Ansari Nagar East, New Delhi
DELHI
110029
India |
| Phone |
01126593676 |
| Fax |
|
| Email |
pavan14281@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Biotechnology, Government of India |
|
|
Primary Sponsor
|
| Name |
Pawan Tiwari |
| Address |
Third Floor, New Private Ward, Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences, Ansari Nagar East, New Delhi |
| Type of Sponsor |
Other [self; investigator initiated trial, funded by DBT] |
|
|
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 |
| Pawan Tiwari |
All India Institute of Medical Sciences, New Delhi |
Third Floor, New Private Ward, Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences, Ansari Nagar East, New Delhi
New Delhi
DELHI |
01126593676
pavan14281@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMTTTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (2) ICD-10 Condition: J439||Emphysema, unspecified, (3) ICD-10 Condition: J42||Unspecified chronic bronchitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combined Yoga plus pulmonary rehabilitation |
Patients will visit AIIMS twice a week in the first week, during which they will be taught the basics of yoga and pulmonary rehabilitation exercises to be performed at home, and their proficiency will be assessed. After the initial two visits, the remaining sessions shall be conducted by patients at home and shall be provided and monitored via telemedicine and smartwatches. |
| Comparator Agent |
In hospital pulmonary rehabilitation |
The Pulmonary Rehabilitation Program will include:
1. Patient education
2. Upper and lower limb exercise training
3. Breathing exercises: Patients will be taught controlled breathing techniques, including pursed-lip breathing, diaphragmatic breathing, forward bending exercises and isometric abdominal muscle exercises.
For the first 4 weeks, participants will visit AIIMS twice a week for supervised sessions, with the remaining sessions to be performed at home. In the following 8 weeks, supervised sessions will occur every other week, and patients will complete the other sessions independently at home. At home sessions shall be virtually monitored using telemonitoring and virtual sessions shall be administered at home to ensure adherence.
|
| Comparator Agent |
In hospital yoga-based rehabilitation |
The yoga intervention will be conducted under the guidance of a qualified yoga instructor and will focus on yoga practice and related components, including patient education and stress management. The yoga practice will involve asanas (physical postures), pranayama (breathing techniques), kriyas (cleansing techniques), meditation, and shavasana (relaxation). The physical practice will begin with breathing and loosening exercises, followed by asanas, pranayama, kriyas, and meditation. Patients will be instructed to maintain specific breathing patterns during each asana. Each strenuous posture will be followed by a corresponding relaxation posture for a brief period.
For the first 4 weeks, participants will visit AIIMS twice a week for supervised sessions, with the remaining sessions to be performed at home. In the following 8 weeks, supervised sessions will occur every other week, and patients will complete the other sessions independently at home. At home sessions shall be virtually monitored using telemonitoring and virtual sessions shall be administered at home to ensure adherence.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Moderate to severe COPD (FEV1 less than 50% predicted)
Controlled symptoms for the last 7 days, without systemic steroids or antibiotics
Willing to participate and attend in-hospital pulmonary rehabilitation for the next 12 weeks
Ready to give written informed consent
|
|
| ExclusionCriteria |
| Details |
Patients requiring hospitalisation (till stabilization/recovery) (shall be reassessed for inclusion after discharge)
On treatment for active respiratory infections (e.g., tuberculosis, chronic pulmonary aspergillosis etc.)
Presence of severe comorbidities such as hematological or solid organ malignancy, symptomatic cardiovascular disease, musculoskeletal or neurological disease that might affect ambulation or exercise training
Ccognitive dysfunction, mental disorder or abnormal behaviors
Inability to follow up as per protocol
Participation in a pulmonary rehabilitation programme in the past 12 months
Currently practicing yoga based rehabilitation
Participating in another interventional trial
Patients with a life expectancy of less than four weeks
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of yoga alone, pulmonary rehabilitation alone, and the combination of yoga and pulmonary rehabilitation in improving exercise capacity, as measured by the 6-minute walk test in patients with moderate to severe chronic obstructive pulmonary disease |
To compare the efficacy of yoga alone, pulmonary rehabilitation alone, and the combination of yoga and pulmonary rehabilitation in improving exercise capacity, as measured by the 6-minute walk test in patients with moderate to severe chronic obstructive pulmonary disease |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Maximal exercise capacity (VO2 max)
• COPD Assessment Test (CAT)
• Lung function (FEV1)
• Forced oscillometry testing parameters (R5, R20, R5-R20, Ax)
• Body plethysmography (Total lung capacity and RV/TLC)
• Time to next exacerbation (months)
• Body composition (using body impedance analysis)
• Inflammatory biomarkers (CRP, SAA, IL-6, IL10, YKL-40, 8-Isoprostane and FENO)
• Feasibility and utility of telemonitored parameters (heart rate, daytime activity, daily step counts, sleep quality and nocturnal saturation) using personalised monitoring (smartwatch) |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pavan14281@gmail.com].
- For how long will this data be available start date provided 01-09-2029 and end date provided 01-02-2032?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The trial is a single center open label randomized parallel group three arm non inferiority study being conducted at AIIMS New Delhi.
116 eligible COPD patients are enrolled and randomised by sex into one of three intervention arms yoga alone,pulmonary rehabilitation alone or combined yoga plus PR, each for 12 weeks.
The interventions include in-person, supervised hospital sessions, followed by telesupervised home sessions using wearable devices to monitor adherence and activity. Primary and Secondary Outcomes Primary outcome is improvement in exercise capacity measured by the 6 minute walk test at 12 weeks.
Secondary outcomes include maximal exercise capacity, VO2 max, COPD Assessment Test, lung function FEV1, forced oscillometry parameters, body plethysmography, time to next exacerbation, body composition, inflammatory biomarkers CRP, SAA, IL6, IL10, YKL40, 8Isoprostane, FENO and feasibility of telemonitored parameters. Methodology and Analysis Inclusion criteria are Moderate to severe COPD with controlled symptoms, willingness for in hospital and home based intervention, written consent.
Exclusion criteria are Active respiratory infections, major comorbidities, inability to perform trial activities, before yoga rehab participation or concurrent trial participation Data analysis is planned via Intention to treat and per protocol approaches with analysis of covariance ANCOVA and adjustments for baseline values and confounders dropouts expected at 20 with results interpreted under CONSORT and noninferiority reporting guidelines Rationale and Expected Impact The study seeks to clarify the clinical effectiveness of combining yoga and PR versus single modalities aiming for improvements in functional capacity inflammation and wellbeing for COPD patients in a cost effective accessible hybrid format.
Outcomes are expected to inform best practices for integrative nonpharmacological management in pulmonary rehabilitation settings. |