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CTRI Number  CTRI/2025/12/099809 [Registered on: 24/12/2025] Trial Registered Prospectively
Last Modified On: 24/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Mix of hospital and home exercise can help people who had tuberculosis after completed the treatment, breath better and feel better in daily life.  
Scientific Title of Study   Effects of hybrid-based pulmonary rehabilitation on exercise capacity and quality of life in individuals with post-tubercular sequelae. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manish Kumar S 
Designation  PG resident 
Affiliation  KMCH College of Physiotherapy 
Address  Department of cardio-respiratory, 1st floor, SF NO:259 and 267 kalapatti post, coimbatore-641048.

Coimbatore
TAMIL NADU
641048
India 
Phone  7338765419  
Fax    
Email  smanishsv@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Catherine Shalini R 
Designation  Associate professor 
Affiliation  KMCH College of Physiotherapy 
Address  Department of cardio-respiratory, Room no:202, SF NO:259 and 267 kalapatti post, coimbatore - 641048.

Coimbatore
TAMIL NADU
641048
India 
Phone  9894586624  
Fax    
Email  catherine@kmchphysiotherapy.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr. RM PL. Ramanathan 
Designation  Consultant Pulmonologist and Lung Transplant Physician 
Affiliation  Kovai Medical center & Hospital 
Address  Department of pulmonology,4thfloor pulmonary rehabilitation center, Kovai Medical Center & Hospital(KMCH), Coimbatore-641014.

Coimbatore
TAMIL NADU
641014
India 
Phone  0422 432 4116  
Fax    
Email  ramurmpl@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  KMCH College of Physiotherapy 
Address  SF NO:259 and 267 kalapatti post coimbatore - 641048, Tamil Nadu, India. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Manish Kumar S  Kovai Medical Center and Hospital (KMCH)  Fourth floor, Department of Pulmonology, Pulmonary Rehabilitation centre, Coimbatore - 641014
Coimbatore
TAMIL NADU 
7338765419

smanishsv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee, KMCH Institute Of Allied Health Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 exercises to improve long term outcomes and enhance the quality of life for 6 weeks period 
Intervention  HYBRID BASED PULMONARY REHABILITATION (Centre based followed by tele-rehabilitation)   Hybrid based pulmonary rehabilitation (Centre based followed by tele-rehabilitation) to improve long-term outcomes and enhance the quality of life for 6 weeks period  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Adult patients 18-65 years.
2.Both male and female individuals.
3.History of treated pulmonary tuberculosis.
4.Diagnosed post tubercular sequelae (fibrotic and bronchiectasis variant) by high resolution computed tomography or chest x-ray.
5.Shortness of breath (mMRC greater than 2).
 
 
ExclusionCriteria 
Details  1.Active tuberculosis infection.
2.Hemoptysis.
3.Patients with severe neurological, musculoskeletal, rheumatologic conditions affecting functional testing.
4.Severe pulmonary hypertension.
5.No participants in pulmonary rehabilitation in the last 6 months.
6.Co-existing respiratory diseases (lung cancer).
7.Unstable cardiac conditions (Unstable angina or recent MI).
8.Severe obstruction less then 30 percentage of FVC and FEV1.
9.Recent thoracic surgery (less than 3months).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Exercise capacity  Baseline,3rd week and 6th week 
 
Secondary Outcome  
Outcome  TimePoints 
Dyspnea, Peak expiratory flow rate, Quality of life  Baseline,3rd week and 6th week 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/01/2026 
Date of Study Completion (India) 05/08/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="12" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 sequelae lead to persistent respiratory symptoms and reduced functional capacity, significantly impacting quality of life. While traditional center-based pulmonary rehabilitation (PR)  has demonstrated benefits in other chronic respiratory conditions-such as COPD, bronchiectasis, cystic fibrosis, asthma with improvements in symptoms, exercise capacity, quality of life, these programs are underutilized due to barriers such as distance from rehabilitation centers, travel difficulties, cost, and time constraints. Hybrid based PR, which combines supervised in-center based sessions and tele-rehabilitation, offers a promising alternative to potentially overcome these limitations and improve patient engagement. There is a need to explore whether hybrid PR models can achieve comparable improvements in dyspnea, exercise capacity and quality of life in patients with post tubercular sequelae patients. A significant research gap exists regarding the application and validation of hybrid PR in this population. Evidence specifically supporting the effectiveness and optimal implementation of PR-particularly hybrid based models- in the context of post-tubercular sequelae remains limited. This research gap necessitates investigation into the feasibility and efficacy of hybrid PR to address the unique needs of individuals with Post-tubercular sequelae, considering the heterogeneity of the condition and the need for tailored interventions. Ultimately, evidence-based research in this area is crucial to develop accessible and effective rehabilitation strategies that can improve long-term outcomes and enhance the quality of life for TB survivors living with the sequelae of the disease.

 
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