| CTRI Number |
CTRI/2025/12/099875 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to assess the effectiveness of Pulmonary Rehabilitation Programme on Physiological and Psychological variables of patients with pulmonary tuberculosis at selected hospital of Ambala, Haryana. |
|
Scientific Title of Study
|
A quasi-experimental study to assess the effectiveness of Pulmonary Rehabilitation Programme on Physiological and Psychological variables of patients with pulmonary tuberculosis at selected hospital of Mullana, Ambala. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Thakur |
| Designation |
PG Student |
| Affiliation |
M.M. College of Nursing, Mullana Ambala |
| Address |
Maharishi Markandeshwar (Deemed To Be University), Mullana Amabala HARYANA 133207
India
Maharishi Markandeshwar (Deemed To Be University), Mullana Amabala Room no.203, Medical Surgical Nursing Department
Ambala
HARYANA
133203
India |
| Phone |
08580598403 |
| Fax |
|
| Email |
shanuthakur.226@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shakuntala |
| Designation |
Assistant Professor |
| Affiliation |
M.M. College of Nursing, Mullana Ambala |
| Address |
Maharishi Markandeshwar (Deemed To Be University), Mullana Amabala HARYANA 133207
India
Maharishi Markandeshwar (Deemed To Be University), Mullana Amabala Room no.203, Medical Surgical Nursing Department
Ambala
HARYANA
133203
India |
| Phone |
7807267792 |
| Fax |
|
| Email |
chauhanshakuntala04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivani Thakur |
| Designation |
PG Student |
| Affiliation |
M.M. College of Nursing, Mullana Ambala |
| Address |
Maharishi Markandeshwar (Deemed To Be University), Mullana Amabala HARYANA 133207
India
Maharishi Markandeshwar (Deemed To Be University), Mullana Amabala Room no.203, Medical Surgical Nursing Department
HARYANA
133203
India |
| Phone |
08580598403 |
| Fax |
|
| Email |
shanuthakur.226@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar Deemed To Be University |
| Address |
Maharishi Markandeshwar (Deemed To Be University), Mullana Amabala, Haryana
India Pin-133207 |
| Type of Sponsor |
Research institution |
|
|
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 Shakuntala |
Maharishi Markandeshwar Institute of Medical Sciences & Research |
M.M. College of Nursing, Medical Surgical Nursing Department, Room no:203
Ambala
HARYANA
Ambala
HARYANA |
7807267792
chauhanshakuntala04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharishi Markandeshwar Institute of Medical Sciences and Research Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J984||Other disorders of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Pulmonary Rehabilitation Programme |
The pulmonary rehabilitation programme include breathing exercises (diaphragmatic with pursed lip breathing and coughing exercise) parayanam and anulom vilom will be administered for 30 minutes in 2 sessions. From day 1 to day 5, pulmonary rehabilitation will be administered for two times a day in the presence of researcher. Each session will be of 30 minutes and each exercise will be performed for 5-6 times. From day 7 to 28, pulmonary rehabilitation will be performed by patients in their homes. Telephonic follow ups will be maintained by researcher to check the compliance with the intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The study included pulmonary tuberculosis patients who are:
more than equal to 18 years of age
admitted in TB-chest ward
willing to participate
capable of understanding English or Hindi.
accessible throughout the data gathering period. |
|
| ExclusionCriteria |
| Details |
The study excluded pulmonary tuberculosis patients who:
is critically ill
have haemoptysis
are above 65 years
stayed in TB-chest ward less than 6 days |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in oxygen saturation level, reducing respiratory rate, heart rate, anxiety and enhance self esteem. |
1 WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in anxiety & enhance self-esteem. |
4 week |
|
|
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)
|
07/01/2026 |
| 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="0"
Months="2"
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
|
“A quasi-experimental study to assess the effectiveness of Pulmonary Rehabilitation Programme on Physiological and Psychological variables of patients with pulmonary tuberculosis at selected hospital of Mullana, Ambala.” The intervention for this research study is: The pulmonary rehabilitation programme include breathing exercises (diaphragmatic with pursed lip breathing and deep breathing exercise) parayanam and anulom vilom will be administered for 30 minutes in 2 sessions. From day 1 to day 5, pulmonary rehabilitation will be administered for two times a day in the presence of researcher. Each session will be of 30 minutes and each exercise will be performed for 5-6 times. From day 7 to 28, pulmonary rehabilitation will be performed by patients in their homes. Telephonic follow ups will be maintained by researcher to check the compliance with the intervention. Possible outcome: Improvement in oxygen saturation level, reducing respiratory rate, heart rate, anxiety and enhancing the self esteem of the patients. |