| CTRI Number |
CTRI/2026/01/100869 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
How Yoga May Improve Quality of Life in People with Interstitial Lung Disease |
|
Scientific Title of Study
|
Effect of Integrated Approach of Yoga Therapy in Interstitial Lung Disease: A Randomised Crossover Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prakriti Bohra |
| Designation |
PhD Student |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Centre for Open and Distance Education (CODE), 2nd Floor, Arogydhama Health Care Block, S-VYASA, Prashanti Kutiram, Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
09828577103 |
| Fax |
|
| Email |
drprakritibohra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Natesh Babu |
| Designation |
Associate Professor |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Centre for Open and Distance Education (CODE), 2nd Floor, Arogydhama Health Care Block, S-VYASA, Prashanti Kutiram, Bangalore
Kalluballu Post, Jigani Hobli
Bangalore
KARNATAKA
560105
India |
| Phone |
09342825813 |
| Fax |
|
| Email |
natesh.babu@svyasa.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prakriti Bohra |
| Designation |
PhD Student |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Centre for Open and Distance Education (CODE), 2nd Floor, Arogydhama Health Care Block, S-VYASA, Prashanti Kutiram, Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
09828577103 |
| Fax |
|
| Email |
drprakritibohra@gmail.com |
|
|
Source of Monetary or Material Support
|
|
RAJASTHAN JAIPURIA HOSPITAL, Kailash Puri Colony, Milap Nagar, Jaipur, Rajasthan, 302018 |
| S-VYASA, Prashanti Kutiram, Vivekananda Road,Kalluballu Post, Jigani, Anekal,
Bengaluru – 560105, INDIA |
|
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Primary Sponsor
|
| Name |
Prakriti Bohra |
| Address |
Prashanti Kutiram, Vivekananda Road,
Kalluballu Post, Jigani, Anekal,Bengaluru – 560105, INDIA |
| Type of Sponsor |
Other [SELF (PhD Student)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Rajasthan Hospital Jaipur |
86, opp. RAJASTHAN JAIPURIA HOSPITAL, Kailash Puri Colony, Milap Nagar, Jaipur, Rajasthan, 302018 |
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prakriti Bohra |
Rajasthan Hospital |
RAJASTHAN JAIPURIA HOSPITAL, 1st Floor, Respiratory Block, Kailash Puri Colony, Milap Nagar, Jaipur
Jaipur
RAJASTHAN |
09828577103
drprakritibohra@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| IEC-SVYASA |
Approved |
| IEC-SVYASA |
Approved |
| RHL ETHICS COMMITTEE |
Approved |
| RHL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J841||Other interstitial pulmonary diseases with fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated Approach of Yoga Therapy (IAYT) |
This study will employ a validated Integrated Approach of Yoga Therapy (IAYT) module specifically designed for patients with Interstitial Lung Disease (ILD).
The total duration of the intervention will be 12 weeks. Yoga sessions will be conducted six days per week, with a 1-hour session each morning (8:00 AM–9:00 AM) delivered through an online platform to ensure accessibility and continuity.
The IAYT program integrates asanas, pranayama, deep relaxation techniques, mental relaxation practices (including MSRT), educational inputs, and counselling, delivered in a structured and progressive manner. Practices will be introduced gradually, beginning with gentle movements and advancing to breathing and mind–body relaxation techniques, with modifications made as required for individual participants. Participants will continue to receive standard medical management for ILD under the supervision of their treating physician, in accordance with established conventional treatment protocols. |
| Comparator Agent |
Walking with Music |
During the 12-week intervention period, participants in the active control group will not receive IAYT and will continue standard medical care for ILD under their treating physician. In addition, they will perform a non-yogic, attention-matched intervention consisting of walking for 30 minutes twice daily (morning and evening), six days per week, while listening to music of their choice. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
a. Patients with stable chronic ILD, including IPF, CTD-ILD, HP, and Undifferentiated ILD, whose diagnosis was made through a multi-disciplinary team discussion.
b. Consent to participate in a 26-week program.
c. An ambulatory patient capable of performing yoga.
|
|
| ExclusionCriteria |
| Details |
a. Forced Vital Capacity less than 50 percent
Continuous Oxygen therapy
b. Diagnosis of pulmonary hypertension
c. Other respiratory diseases apart from ILD
d. Rapidly Progressive (RP-ILD) or unstable disease
e. Diagnosis of Cardio-respiratory failure, advanced malignancy, renal or hepatic failure, neurological diseases such as Parkinson’s, epilepsy and stroke.
f. Pulmonary infection, Acute exacerbation and other respiratory declines within the last 4 weeks
g. Recent abdominal surgery
h. Pregnant women
i. On anxiety/depression-related drugs
j. Patients admitted to the hospital (inpatients)
k. Patients who are currently on self-medication for ILD or any respiratory condition.
l. Patients who are receiving any form of alternative or complementary therapy, including but not limited to Ayurveda, Unani, Homoeopathy, Naturopathy, Siddha, Tibetan medicine, or other traditional/folk therapies.
m. Co-morbidities which make yoga training impossible
n. Who are regular yoga practitioners and engaged in systematic physical activities and mindfulness practice
|
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Method of Generating Random Sequence
|
Stratified randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Health related Quality of life: CDC-HRQoL and St. George Respiratory Questionnaire (SGRQ) |
Five key timepoints
Pre-Intervention; One Week After Baseline 1; After the First 12-Week Intervention Period; After the 2-Week Washout Period; After the Second 12-Week Intervention Period |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Functional exercise capacity: Six-Minute Walk Distance by Six-Minute Walking Test
|
Five key timepoints
Pre-Intervention; One Week After Baseline 1; After the First 12-Week Intervention Period; After the 2-Week Washout Period; After the Second 12-Week Intervention Period |
| Pulmonary function: Spirometry |
Five key timepoints
Pre-Intervention; One Week After Baseline 1; After the First 12-Week Intervention Period; After the 2-Week Washout Period; After the Second 12-Week Intervention Period |
| Dyspnoea: Modified Medical Research Council Dyspnoea Scale (mMRC) |
Five key timepoints
Pre-Intervention; One Week After Baseline 1; After the First 12-Week Intervention Period; After the 2-Week Washout Period; After the Second 12-Week Intervention Period |
| Fatigue: Borg Rating of Perceived Exertion (RPE) 6–20 |
Five key timepoints
Pre-Intervention; One Week After Baseline 1; After the First 12-Week Intervention Period; After the 2-Week Washout Period; After the Second 12-Week Intervention Period |
| Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) |
Five key timepoints
Pre-Intervention; One Week After Baseline 1; After the First 12-Week Intervention Period; After the 2-Week Washout Period; After the Second 12-Week Intervention Period |
| Lung Capacity: Breath Holding Time |
Five key timepoints
Pre-Intervention; One Week After Baseline 1; After the First 12-Week Intervention Period; After the 2-Week Washout Period; After the Second 12-Week Intervention Period |
| Respiratory Rate (Brahmari) |
Five key timepoints
Pre-Intervention; One Week After Baseline 1; After the First 12-Week Intervention Period; After the 2-Week Washout Period; After the Second 12-Week Intervention Period |
|
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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
|
N/A |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- 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 [drprakritibohra@gmail.com].
- For how long will this data be available start date provided 02-01-2028 and end date provided 02-01-2031?
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
Modification(s)
|
The current study will be a single-centre, randomized, assessor-blinded crossover clinical trial to evaluate the effect of an Integrated Approach to Yoga Therapy compared with walking with music in patients with stable interstitial lung disease. Participants will be randomly allocated to one of two parallel sequences. One sequence will receive yoga therapy for 12 weeks, followed by a 15-day washout period, and then walking with music for 12 weeks. The other sequence will receive walking with music first, followed by washout and then yoga therapy. Standard medical care will be continued throughout the study. The primary outcome will be health-related quality of life assessed using validated respiratory and general health questionnaires. Secondary outcomes will include functional exercise capacity, pulmonary function, dyspnoea, fatigue, anxiety, and depression, sleep quality, breath-holding time, and duration of Bhramari pranayama. Outcome assessments will be conducted at five timepoints, including two baseline assessments one week apart, post-first intervention, post-washout, and post-second intervention. This crossover design will allow each participant to act as their own control while minimizing inter individual variability and enabling evaluation of treatment time and carryover effects. The study will aim to generate clinical evidence for yoga as a structured non-pharmacological adjunct in the management of interstitial lung disease. |