| CTRI Number |
CTRI/2026/01/101266 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Pulmonary Rehabilitation] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of a Supervised Exercise and Breathing Training Program on Walking Capacity in Patients with Lung Problems After Tuberculosis |
|
Scientific Title of Study
|
Effect of Pulmonary Rehabilitation versus Standard Care on Exercise Capacity in Post-Tubercular Lung Disease Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anirudh Mishra |
| Designation |
DM Resident |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Pulmonary, Critical Care and Sleep Medicine,
Room no. 541,
Level 5,
Block D,
GMCH, Sector 32
Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9649837031 |
| Fax |
|
| Email |
mishra.anirudh18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Aggarwal |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Medical College and Hospital |
| Address |
Room no. 541
Level 5
Block D
Government Medical College and Hospital
Sector 32
Chandigarh
sector 32
chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121584 |
| Fax |
|
| Email |
drdeepak@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Aggarwal |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Medical College and Hospital |
| Address |
Room no. 541
Level 5
Block D
Government Medical College and Hospital
Sector 32
Chandigarh
sector 32
chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121584 |
| Fax |
|
| Email |
drdeepak@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, sector 32, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Department of Pulmonary, Critical Care and Sleep Medicine,
Room no. 541,
Level 5,
Block D,
GMCH, Sector 32,
Chandigarh
Pin Code - 160030 |
| Type of Sponsor |
Government 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 |
| Dr Anirudh Mishra |
Government Medical College and Hospital |
Department of Pulmonary, Critical Care and Sleep Medicine,
Room no. 541,
Level 5,
Block D,
Sector 32
Chandigarh
CHANDIGARH |
9649837031
mishra.anirudh18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(GMCH, Chandigarh) |
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 |
| Intervention |
Pulmonary Rehabilitation |
The intervention group (PR Group) will undergo an 8-week comprehensive pulmonary rehabilitation program, comprising 16 supervised sessions (twice weekly) at the hospital’s PR centre. The program will include aerobic training including walking over trade mill or cycling for 10-15 minutes, strength training for upper and lower limbs in terms of bicep curls, sit-to-stand and step-up exercises including 2–3 sets of 8–12 repetitions for 15-20 minutes. The use of Therabands/light weights will be done for resistance training, inspiratory muscle training will be done using incentive spirometry along with flexibility and balance exercises for 15-20 minutes. The patient will be continuously monitored during exercise period for any drop in SPO2 and uncontrollable breathlessness and fatigue. Along with in-hospital sessions, patients will also be advised for 30 minutes of aerobic exercise at home.
Educational sessions will be conducted at baseline which will focus on disease awareness including its symptoms and complications, breathing techniques such as diaphragmatic breathing, pursed-lip breathing and airway clearance techniques. Patients will be counselled regarding smoking cessation, nutritional education including dietary advice and medication adherence. |
| Comparator Agent |
Standard Care |
The control group (Standard care group) will receive standard medical care including optimization of pharmacological therapy, routine follow-up visits, and general advice about the benefits of exercise and healthy lifestyle as a part of standard care. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who have completed anti-tuberculosis treatment successfully at least 2 months prior to enrollment.
2. Sputum negative prior to enrollment. |
|
| ExclusionCriteria |
| Details |
1. Acute respiratory worsening in preceding 4 weeks
2. Unstable cardiac disease such as unstable angina, recent MI, severe HF
3. Severe orthopedic conditions limiting intervention exercises
4. Active malignancy
5. Severe cognitive impairment preventing participation
6. Pregnancy
7. Resting hypoxemia that is SpO2 less than 88% on room air requiring continuous O2
8. Active TB including drug-resistant TB |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in 6-minute walk distance from baseline to 8 weeks in the two treatment arms.
|
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in quality of life and lung function parameters from baseline to 8 weeks in the two treatment arms. |
8 weeks |
| Sustained effects of pulmonary rehabilitation on 6-minute walk test distance, quality of life and lung function parameters at 12 weeks in PR group |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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="1"
Months="6"
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
|
Post-tubercular lung disease is a common cause of chronic respiratory symptoms, reduced exercise capacity, and impaired quality of life even after successful completion of anti-tuberculosis treatment. Pulmonary rehabilitation has proven benefits in other chronic respiratory diseases, but evidence in PTLD remains limited. This study is a prospective, randomized, parallel-group, non-blinded controlled trial designed to evaluate the effect of an 8-week structured pulmonary rehabilitation program compared with standard medical care in patients with post-tubercular lung disease. A total of 70 eligible patients will be randomized in a 1:1 ratio to either the pulmonary rehabilitation group or the standard care group. The pulmonary rehabilitation program will include supervised aerobic training, strength training, inspiratory muscle training, flexibility and balance exercises, along with patient education and home-based exercises. The control group will receive standard pharmacological management and lifestyle advice. The primary outcome is the change in six-minute walk distance from baseline to 8 weeks. Secondary outcomes include changes in lung function parameters, quality of life scores, and assessment of sustained benefits at 12 weeks in the rehabilitation group. The study aims to generate evidence on the role of pulmonary rehabilitation in improving functional capacity and overall health status in patients with post-tubercular lung disease. |