| CTRI Number |
CTRI/2026/04/107436 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
02/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Respiratory Therapy ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Home based Pulmonary Rehabilitation among Adult Patients Suffering with Stable Interstitial Lung Diseases |
|
Scientific Title of Study
|
Effectiveness of Home based Pulmonary Rehabilitation among Adult Patients Suffering with Stable Interstitial Lung Diseases: A Randomized Control 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 |
Abu Talha hanfi |
| Designation |
Head of Respiratory Therapist |
| Affiliation |
Symbiosis International (Deemed University) |
| Address |
Symbiosis International (Deemed University)Lavale , Mulshi, Pune , Maharashtra 412115
Pune
MAHARASHTRA
4112115
India |
| Phone |
7387143678 |
| Fax |
|
| Email |
abutalhahanfi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sammita Jadhav |
| Designation |
Director |
| Affiliation |
Symbiosis Institute of health sciences |
| Address |
Symbiosis International (Deemed University)
Symbiosis Institute of health sciences
5th floor hill base.
Lavale , Mulshi, Pune , Maharashtra
Pune
MAHARASHTRA
4112115
India |
| Phone |
9527355053 |
| Fax |
|
| Email |
director_sihs@siu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Abu Talha hanfi |
| Designation |
Head of Respiratory Therapist |
| Affiliation |
Symbiosis International (Deemed University) |
| Address |
Symbiosis International (Deemed University)Lavale , Mulshi, Pune , Maharashtra 412115
Pune
MAHARASHTRA
4112115
India |
| Phone |
7387143678 |
| Fax |
|
| Email |
abutalhahanfi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Symbiosis university Hospital and research centre
Lavale,pune Maharashtra
412115 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [no sponsor ] |
|
|
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 |
| DrSammita jadhav |
Symbiosis University Hospital and Research Center |
TB chest OPD ground floor general hospital building.
Symbiosis international (Deemed university ) campus, hill base, lavale,Tal : Mulshi , Pune 412115.
Pune
MAHARASHTRA |
9527355053
director_sihs@siu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| INDEPENDENT EITHICS COMMITTEE |
Approved |
| Independent Ethics Committee(BHR)-SIU |
Approved |
| INDEPENDENT ETHICS COMMITTEE |
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 |
| Intervention |
home base pulmonary rehab program |
Type Rehabilitation
Intervention name Home Based Pulmonary Rehabilitation Program
Details of Intervention
Adult patient with stable ILD in the Intervention group will a structured Home Based Pulmonary Rehabilitation Program . The program will include breathing ,aerobic exercises and upper and lower limb strengthening exercises . participant will also receive education regarding disease management ,energy conservation technique and lifestyle modification .The rehabilitation program will be performed at home for specified duration 12 months will regular monitoring and follow up through telephone calls and periodic supervision by the Investigator/ Respiratory Therapist to ensure adherence and safety.
|
| Comparator Agent |
standard medical care and routine follow up |
Frequency- monthly twice |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Stable Medical therapy with no active infection .
Stable ILD
mMrc Till grade 3
|
|
| ExclusionCriteria |
| Details |
Co-morbidities such as unstable angina , recent myocardial infraction or cerebrovascular accident , active cancer, severe orthopaedics disorders
Systematic menifeststions such as active myopathy , arthaalagia and sinusitis
Any neurological and cognitive impairment
Saturation less than 88%
unstable ILD
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pulmonary Function Test
Six min Walk test
DLCO
|
First measure at baseline , then at 3 , 6 9 ,12 months follow up
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
borg scale
mMRC GRADE
st.george respiratory questionair |
First measure at baseline then 3,6 ,9 12 months follow up |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
14/04/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The scope of this study is very widespread. There is abundance of evidence which is available for COPD but this study includes other ILD. The knowledge, awareness and prevention of respiratory diseases is very important. Pulmonary rehabilitation is a combination of multidimensional which helps the patient to improve the quality of life. Mostly the study was conducted by physiotherapist but by the reach of my knowledge it is the first study which will be conducted by respiratory therapist. There are many barriers which is related to pulmonary rehabilitation this study helps us to reduce the barriers and guide them for prevention of the diseases. |