| CTRI Number |
CTRI/2022/03/041223 [Registered on: 21/03/2022] Trial Registered Prospectively |
| Last Modified On: |
18/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
effect of short term pulmonary rehabilitation among pulmonary tuberculosis patients during covid-19 pandemic |
|
Scientific Title of Study
|
Effect of short term Pulmonary rehabilitation among pulmonary tuberculosis patients during covid 19 pandemic |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Munazzah Orooj |
| Designation |
PhD Scholar |
| Affiliation |
Teerthanker Mahaveer University Moradabad |
| Address |
Room number 502 5th floor
Department of physiotherapy Teerthanker Mahaveer University Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8744873780 |
| Fax |
|
| Email |
munazzaorooj999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divender Kumar Singh |
| Designation |
Assistant Professor |
| Affiliation |
Teerthanker Mahaveer University Moradabad |
| Address |
Room number 8
Ground Floor
Department of Respiratory Medicine
Room 9
ground floor
Department of Respiratory Medicine
Sharda Hospital
Gautam Buddha Nagar
UTTAR PRADESH
244001
India |
| Phone |
8744873780 |
| Fax |
|
| Email |
dr.deva29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Munazzah Orooj |
| Designation |
PhD Scholar |
| Affiliation |
Teerthanker Mahaveer University Moradabad |
| Address |
Room no 501
5th Floor
Department of Physiotherapy Teerthanker Mahaveer University Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8744873780 |
| Fax |
|
| Email |
munazzaorooj999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy School of Allied Health and Sciences
Sharda Hospital
Greater Noida
Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Munazzah Orooj |
| Address |
Teerthanker Mahaveer University Moradabad |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Teerthanker Mahaveer University Moradabad |
Teerthanker Mahaveer University Moradabad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Munazzah Orooj |
Sharda Hospital |
Room 12 DOT CENTER respiratory medicine Sharda Hospital
Gautam Buddha Nagar
UTTAR PRADESH |
8744873780
munazzaorooj999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J989||Respiratory disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group with usual care |
usual care with identical follow up with no physiotherapy |
| Intervention |
pulmonary rehabilitation |
Patients assigned to the rehabilitation group were Invited to attend a minimum of a 4-weeks (4 sessions/week) outpatient rehabilitation program with a total of 16 sessions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria includes all patients with pulmonary tuberculosis 18 years of age and older, exhibit shortness of breath on exertion, have limitations in the activity of daily living and patients who have completed their chemotherapy |
|
| ExclusionCriteria |
| Details |
Exclusion criteria include all the contraindications of pulmonary rehabilitation such as a history of myocardial infarction, angina, and congestive heart failure. An older patient with age above 80 years and patients with orthopedic or cognitive impairment that would interfere with the regular participation in the rehabilitation program. Those who are unwilling or unable to attend the PR program |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
PULMONARY REHABILITATION
Aerobic training (Walking)resistance training and education will be provided and Quality of life along with lung function and exercise tolerance will be checked at baseline and after 4 weeks |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PULMONARY FUNCTION TEST
SGRQ
6 MINUTE WALK DISTANCE TEST |
4 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
31/03/2022 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NO PUBLICATION |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Objective: To investigate the effect of short-term Pulmonary Rehabilitation program (PR) among Pulmonary tuberculosis patients during pandemic. Methods: Twenty-eight patients will be randomly allocated to the PR group, which comprised of supervised endurance training, resistance training, breathing exercises, self-management, and education. The other 28 patients will be allocated to the control group, who will be asked to continue their usual routine strategies for four weeks. All measurements will be made at enrolment and after completion of 4 weeks of Pulmonary Rehabilitation using the six-minute walk test (6MWT), Modified Medical Research Council (Mmrc) Dyspnea Scale, pulmonary function test (PFT), and SF-36. |