| CTRI Number |
CTRI/2026/03/105417 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Evaluate the Benefits of PNF Stretching Combined with Pulmonary Rehabilitation in Patients with Interstitial Lung Disease |
|
Scientific Title of Study
|
Effect of Proprioceptive Neuromuscular Facilitation Stretching with Pulmonary Rehabilitation in Patients with Interstitial Lung Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Iqra Tabasum |
| Designation |
MPT (cardiopulmonary) |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room no. 102, Ist floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi- 110025
South
DELHI
110025
India |
| Phone |
9149948300 |
| Fax |
|
| Email |
iqratabasum07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Iqra Tabasum |
| Designation |
MPT (cardiopulmonary) |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room no. 102, Ist floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi- 110025
South
DELHI
110025
India |
| Phone |
9149948300 |
| Fax |
|
| Email |
iqratabasum07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Iqra Tabasum |
| Designation |
MPT (cardiopulmonary) |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room no. 102, Ist floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi- 110025
South
DELHI
110025
India |
| Phone |
9149948300 |
| Fax |
|
| Email |
iqratabasum07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no.13,3rd floor, Metro Centre for Respiratory Diseases,
Metro Hospitals and Heart Institute, Noida
L-Block, Sector 11, Gautam Buddha Nagar
Uttar Pradesh, India-201301. |
|
|
Primary Sponsor
|
| Name |
Centre for Physiotherapy and Rehabilitation Sciences |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi-110025 |
| Type of Sponsor |
Other [Central University] |
|
|
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 |
| Iqra Tabasum |
Metro Hospitals and Heart Institute |
Room no.13,3rd floor, Metro Centre for Respiratory Diseases,
Metro Hospitals and Heart Institute, Noida
L-Block, Sector 11, Gautam Buddha Nagar
Uttar Pradesh, India-201301.
Gautam Buddha Nagar
UTTAR PRADESH |
9149948300
iqratabasum07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jamia Millia Islamia, New Delhi |
Approved |
| Metro Ethical Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Comparator Agent |
Pulmonary Rehabilitation (PR) |
This group will participate in supervised Pulmonary Rehabilitation (PR) three times a week for six weeks, on non-consecutive days.
|
| Intervention |
Pulmonary Rehabilitation (PR) with Proprioceptive Neuromuscular Facilitation (PNF) Stretching |
This group will perform
supervised Pulmonary Rehabilitation (PR) plus Proprioceptive Neuromuscular Facilitation (PNF) Stretching three times per week for six weeks on non-consecutive days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Clinically stable patient and ambulant ILD patient.
Dyspnea on exertion despite medical treatment.
Willing and able to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
Concurrent and predominant pulmonary disease other than ILD.
Presence of comorbidities that can preclude exercise programme (such as severe orthopaedic or neurological deficit or unstable cardiac disease).
Showed unwillingness to follow the protocol.
Unable to speak and/or understand Hindi/English.
Participation in another pulmonary rehabilitation program within the past 6 months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lung function- FVC, FEV1, FEV1/FVC, TLC, DLCO |
Baseline and after 6 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exercise capacity, Thoracic expansion, Dyspnea and Health-related quality of life |
Baseline and after 6 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/03/2026 |
| 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="0"
Months="2"
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 - NO
|
|
Brief Summary
|
This prospective, randomized controlled trial will evaluate whether adding Proprioceptive Neuromuscular Facilitation stretching to conventional pulmonary rehabilitation improves clinical outcomes compared to pulmonary rehabilitation alone in patients with Interstitial Lung Disease. A total of 40 clinically stable adult patients with Interstitial Lung Disease will be randomly allocated into two groups. Both groups will receive supervised pulmonary rehabilitation three times per week for six weeks. The experimental group will receive additional Proprioceptive Neuromuscular Facilitation stretching targeting respiratory and postural muscles during the rehabilitation sessions, while the control group will receive pulmonary rehabilitation alone. Baseline assessments will include pulmonary function parameters, thoracic expansion, exercise capacity, dyspnea severity, and health-related quality of life will be collected one day before intervention and post intervention assessments will be conducted after completion of 18 sessions using standardised outcome measures. |