| CTRI Number |
CTRI/2024/08/073001 [Registered on: 27/08/2024] Trial Registered Prospectively |
| Last Modified On: |
24/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Pulmonary Rehabilitation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
What pulmonary rehabilitation does on exercise capacity in post-tuberculosis lung disease |
|
Scientific Title of Study
|
Effect of pulmonary rehabilitation on six minute walk distance and diaphragmatic excursion in post-tuberculosis lung disease |
| 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 Satish Kumar Kumawat |
| Designation |
DM Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Pulmonary Medicine, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9610667900 |
| Fax |
|
| Email |
kumawatsatishkumar6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranav Ish |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Pulmonary, Critical care & Sleep Medicine, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9958356000 |
| Fax |
|
| Email |
pranavish2512@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satish Kumar Kumawat |
| Designation |
DM Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Pulmonary Medicine, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9610667900 |
| Fax |
|
| Email |
kumawatsatishkumar6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, Delhi (India) 110029 |
|
|
Primary Sponsor
|
| Name |
VMMC & SJH |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, Delhi 110029 |
| 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 Satish Kumar Kumawat |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Pulmonary Medicine and Department of PMR, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
New Delhi
DELHI |
9610667900
kumawatsatishkumar6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College & Safdarjung Hospital Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: J40-J47||Chronic lower respiratory diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Not applicable |
| Intervention |
Pulmonary Rehabilitation |
After meeting the inclusion and exclusion criteria, patients will receive pulmonary rehabilitation for the period of eight weeks. This will include stretching exercises, strength training exercises, and aerobic conditioning exercises. This will be done three times a week including at least one session in the hospital setting. Educational sessions on breathing exercises, energy conservation, lung health, and nutrition will also be given to the patient. At the end of eight weeks of the pulmonary rehabilitation program, the results will be compared to the baseline. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 to 60 years
2. Patients priorly diagnosed with pulmonary TB
and completed a course of anti-tubercular
therapy (ATT) with evidence of chronic
respiratory abnormality, with or without
symptoms, attributable at least in part to
previous tuberculosis. |
|
| ExclusionCriteria |
| Details |
1. Currently diagnosed with pulmonary tuberculosis,
2. Diagnosed with Asthma and COPD before ATT,
3. Hospital admission or exacerbation within the last 4 weeks,
4. Unstable cardiovascular disease,
5. Physical disability not permitting pulmonary rehabilitation and
6. Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of pulmonary rehabilitation on a six-minute walk distance and diaphragmatic excursion in post-tuberculosis lung disease |
Baseline and End of 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of pulmonary rehabilitation on spirometry, health-related quality of life, and symptoms in post-tuberculosis lung disease |
Baseline and End of 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
05/09/2024 |
| 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
|
Pulmonary rehabilitation is an important aspect in the management of chronic respiratory diseases such as chronic obstructive pulmonary disease, interstitial diseases, cystic fibrosis, and asthma with benefits in symptoms, exercise capacity, and quality of life. In India, there is a lack of studies regarding the effect of pulmonary rehabilitation on six-minute walk distance and diaphragmatic excursion in post-tuberculosis lung disease. The purpose of this study is to evaluate whether patients with post-tuberculosis lung disease will have an improvement in six-minute walk distance and diaphragmatic excursion or not. This study is a prospective interventional study. |