| CTRI Number |
CTRI/2026/04/107554 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
02/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effects of guided exercise based training in patients who had TB previously |
|
Scientific Title of Study
|
Effectiveness of Pulmonary Rehabilitation in patients with post TB sequelae A non randomised controlled 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 |
Mitali Vijay Salve |
| Designation |
Junior Resident |
| Affiliation |
NKP Salve &Lata Mangeshkar Hospital |
| Address |
NKP Salve &Lata Mangeshkar Hospital Vidhyachal hostel room no2 Hingna road Police Nagar Digdoh
Vidhyachal hostel room no2 Hingna road Police Nagar Digdoh
nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9969558650 |
| Fax |
|
| Email |
mitalisalve@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANIL SONTAKKE |
| Designation |
PROFESSOR AND HEAD, DEPARTMENT OF RESPIRATORY MEDICINE |
| Affiliation |
NKP Salve &Lata Mangeshkar Hospital |
| Address |
DEPARTMENT OF RESPIRATORY MEDICINE, LATA MANGESHKAR HOSPITAL, CRPF CAMP, DIGHDOH HILLS, HINGNA, NAGPUR
DEPARTMENT OF RESPIRATORY MEDICINE, LATA MANGESHKAR HOSPITAL, CRPF CAMP, DIGHDOH HILLS, HINGNA, NAGPUR
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9869027857 |
| Fax |
|
| Email |
anilsontakke66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANIL SONTAKKE |
| Designation |
PROFESSOR AND HEAD, DEPARTMENT OF RESPIRATORY MEDICINE |
| Affiliation |
NKP Salve &Lata Mangeshkar Hospital |
| Address |
DEPARTMENT OF RESPIRATORY MEDICINE, LATA MANGESHKAR HOSPITAL, CRPF CAMP, DIGHDOH HILLS, HINGNA, NAGPUR
DEPARTMENT OF RESPIRATORY MEDICINE, LATA MANGESHKAR HOSPITAL, CRPF CAMP, DIGHDOH HILLS, HINGNA, NAGPUR
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9869027857 |
| Fax |
|
| Email |
anilsontakke66@gmail.com |
|
|
Source of Monetary or Material Support
|
| NKP SALVE INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE AND LATA MANGESHKAR HOSPITAL, CRPF CAMP, DIGHDOH, NAGPUR |
|
|
Primary Sponsor
|
| Name |
NKP SALVE INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE AND LATA MANGESHKAR HOSPITA |
| Address |
CRPF CAMP, DIGHDOH,HINGNA, NAGPUR |
| Type of Sponsor |
Private medical college |
|
|
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 |
| MITALI SALVE |
NKP SALVE INSTITUTE OF MEDICAL SCIENCES AND LATA MANGESHKAR HOSPITAL |
DEPARTMENT OF RESPIRATORY MEDICINE, SECOND FLOOR, WARD2
Nagpur
MAHARASHTRA |
9969558650
mitalisalve@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NKP SALVE INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A150||Tuberculosis of lung, (2) ICD-10 Condition: A150||Tuberculosis of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL
|
NIL |
| Intervention |
Pulmonary Rehabilitation |
Post TB patients will be taught exercises on their visit in opd and ward patients. Progress will be assessed in terms of quality of life, mmrc grding, improvement in dyspnea scale. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients more than 18 years who have completed treatment of pulmonary TB and are bacteriologically negative at the end of treatment. |
|
| ExclusionCriteria |
| Details |
Patients requiring supplemental oxygen support, patients with acute respiratory failure, patients not able to perform exercises, mentally retarted patients, pregnant women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)To evaluate the effectiveness of Pulmonary rehabilitation in patients with post-TB sequelae with respect to A) St George Respiratory Questionnare B) MMRC grading C)6min walk test D)Pulmonary function test |
Assessment will be done on admission, 1 week, 2 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
29/04/2026 |
| 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="5"
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
|
Pulmonary TB is a major public health concern in India. More focus is on the cure rate and the patient has to just follow up with routine investigations. Many surviors continue to have limitations affecting overall quality of life. The aim of this study is to improve quality of life in patients with post-Tb sequelae which could add to existing research on this topic. |