| 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
|
|
|
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
|
|
|
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
|
|
|
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. |