| CTRI Number |
CTRI/2025/07/090423 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The Benefits of Diaphragmatic Stretching for Lung Health After TB |
|
Scientific Title of Study
|
Effect of Diaphragmatic Stretching on
Cardiopulmonary Parameter in Post Pulmonary TB Sequalae Patient |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Minal Fiza |
| Designation |
MPT student |
| Affiliation |
Delhi Pharmaceutical Sciences and Research University |
| Address |
Room no.605,Delhi Pharmaceutical Sciences and Research University, school of physiotherapy , 6th floor,
school of physiotherapy, sector-3, pushp vihar, M.B. Road New Delhi - 10017
India
South
DELHI
110017
India |
| Phone |
9319501324 |
| Fax |
|
| Email |
20minalfiza@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Minal Fiza |
| Designation |
MPT student |
| Affiliation |
Delhi Pharmaceutical Sciences and Research University |
| Address |
Room no.605,Delhi Pharmaceutical Sciences and Research University, school of physiotherapy , 6th floor,
school of physiotherapy, sector-3, pushp vihar, M.B. Road New Delhi - 10017
India
South
DELHI
110017
India |
| Phone |
9319501324 |
| Fax |
|
| Email |
20minalfiza@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Richa H Rai |
| Designation |
professor |
| Affiliation |
Delhi Pharmaceutical Sciences and Research University |
| Address |
room no. 605, Delhi Pharmaceutical Sciences and Research University,
school of physiotherapy, 6th floor, new building.
sector-3, pushp vihar, M.B. Road New Delhi - 10017
India
South
DELHI
110017
India |
| Phone |
9350267077 |
| Fax |
|
| Email |
richarai@dpsru.edu.in |
|
|
Source of Monetary or Material Support
|
| National Institute of TB and Respiratory Diseases hospital, Department of physiotherapy, 1st floor, Room no. 115, OPD building. Sri Aurobindo Marg Near Qutub Minar, Mehrauli, New Delhi, Delhi 110030 India
South
DELHI |
|
|
Primary Sponsor
|
| Name |
Delhi Pharmaceutical Sciences and Research University |
| Address |
Delhi Pharmaceutical Sciences and Research University, school of physiotherapy, sector-3, pushp vihar. Road New Delhi -10017
India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| National Institute of TB and Respiratory Diseases hospital |
National Institute of TB and Respiratory Diseases hospital, Department of physiotherapy, 1st floor, Room no. 115, OPD building. Sri Aurobindo Marg Near Qutub Minar, Mehrauli, New Delhi, Delhi 110030 India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Minal Fiza |
National Institute of TB and Respiratory Diseases hospital |
National Institute of TB and Respiratory Diseases hospital, Department of physiotherapy, 1st floor, Room no. 115, OPD building.
Sri Aurobindo Marg Near Qutub Minar, Mehrauli, New Delhi, Delhi 110030
India
South
DELHI |
09319501324
20minalfiza@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| post graduate ethics committee |
Approved |
| Student research development committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B909||Sequelae of respiratory and unspecified tuberculosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional
physiotherapy |
Conventional Physiotherapy, includes breathing exercises (segmental breathing), Mucus clearance techniques, and shoulder mobility exercises.
time for the protocol last for the 30-45 min in group. Then immediate effect will be recorded.total duration of this study will be 2 months.
|
| Intervention |
Diaphragmatic stretching along with
conventional physiotherapy. |
diaphragmatic stretching is given for 2 set of 10 breath and 1 min rest in between, total.
Conventional Physiotherapy, includes breathing exercises (segmental breathing), Mucus
clearance techniques, and shoulder mobility exercises.
time for the protocol last for the 30-45 min in group. The intervention will be given and
immediate effect will be recorded.
total duration of this study will be 2 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with post pulmonary TB sequalae who are diagnosed and
referred by the pulmonologist or physician.
2.Both the gender will be included
3.Subject who has Completed course of ATT.
4.Subject with sputum smear as well as culture negative.
5. X-Ray finding show no active infection finding. |
|
| ExclusionCriteria |
| Details |
1.Patient with multi drug resistant TB.
2.Life threating disorder.
3.History of recent cardiothoracic or abdominal surgery.
4.Acute rib fracture.
5.History of psychiatric illness.
• Recent history of chest wall or abdominal trauma.
• History of any other neurological, psychological, systemic, musculoskeletal disorder
that can interfere with the rehabilitation programme or can affect the outcome of the
study |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) PEFR (peak expiratory flow rate) (l/min)
b) Resting Heart rate (bpm)
c) chest expansion (cm)
d) Oxygen saturation(Spo2) |
pre- before intervention
post - after intervention on the same day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| a) Resting blood pressure (mmhg) |
pre- before intervention
post - after intervention on the same day |
|
|
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)
|
21/07/2025 |
| 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="0"
Months="2"
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
|
This study investigates the effect of diaphragmatic stretching on cardiopulmonary parameters in patients with post tuberculosis lung sequelae. The primary aim is to evaluate whether diaphragmatic stretching can improve respiratory functions such as PEFR chest expansion and other cardiopulmonary measures in these patients potentially aiding in respiratory rehabilitation and management of post TB lung damage. |