| CTRI Number |
CTRI/2024/05/067501 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
11/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral
Other (Specify) [Pulmonary Rehabilitation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
clinical trial to assess the effectiveness of pulmonary rehabilitation among patient with pulmonary tuberculosis |
|
Scientific Title of Study
|
A STUDY TO ASSESS THE EFFECTIVENESS OF PULMONARY REHABILITATION ON KNOWLEDGE, ATTITUDE, PRACTICE, PULMONARY FUNCTIONAL MEASURES AND HEALTH RELATED QUALITY OF LIFE AMONG THE PATIENTS WITH PULMONARY TUBERCULOSIS AT SELECTED TB CENTERS IN THIRUVALLUR |
| Trial Acronym |
TB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Packialakshmi. K |
| Designation |
Assistant Professor |
| Affiliation |
Faculty of Nursing, Dr. MGR Educational and Research Institute |
| Address |
Faculty of Nursing,
ACS Medical College and Hospital Campus,
Dr. MGR Educational and Research Institute, Chennai - 600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9894261806 |
| Fax |
|
| Email |
lakshmikpackia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Packialakshmi. K |
| Designation |
Assistant Professor |
| Affiliation |
Faculty of Nursing, Dr. MGR Educational and Research Institute |
| Address |
Faculty of Nursing,
ACS Medical College and Hospital Campus,
Dr. MGR Educational and Research Institute, Chennai - 600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9894261806 |
| Fax |
|
| Email |
lakshmikpackia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Packialakshmi. K |
| Designation |
Assistant Professor |
| Affiliation |
Faculty of Nursing, Dr. MGR Educational and Research Institute |
| Address |
Faculty of Nursing,
ACS Medical College and Hospital Campus,
Dr. MGR Educational and Research Institute, Chennai - 600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9894261806 |
| Fax |
|
| Email |
lakshmikpackia@gmail.com |
|
|
Source of Monetary or Material Support
|
| DHS NTEP
District TB Center,
Poonamallee, CHennai |
|
|
Primary Sponsor
|
| Name |
Dr Sangeetha |
| Address |
DHS - NTEP,
TB Centers,
Poonamallee.
Thiruvallur - 600 056 |
| 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 |
| Dr Hema V H |
District TB Center |
Room Number 1,
Examination Room,
DHS - NTEP,
Poonamallee,
Thiruvallur - 600 056
Thiruvallur
TAMIL NADU |
9444383220
lakshmikpackia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, ACS Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A157||Primary respiratory tuberculosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Intervention. |
Continuous assessment and routine care. |
| Intervention |
Pulmonary Rehabilitation |
Pulmonary rehabilitation program will be given to TB patients assigned in the experimental group.
Health teaching about Tuberculosis and pulmonary rehabilitation program with the help of hand book.
In physical exercise therapy - The targeted heart rate will be calculated by Korvonean formula and fixed from 40% to 85%. Warm up exercise such as Arm circle, Shoulder rolls, neck stretches and gentle leg exercise will be provided for 5 minutes. Aerobic exercise of walking will be provided. The pulse oximetry will be connected with patient and advice to walk till targeted heart rate achieved. Followed by aerobic exercise, cool down exercise such as Arm circle, Shoulder rolls, neck stretches and gentle leg exercise will be provided for 5 minutes
Followed by cool down exercise diaphragmatic breathing Exercise will be provided for 3 minutes.
Minimum 2 sessions in a week for 12 weeks.
Subjects of control group will receive care as usual and after the post test, pulmonary rehabilitation program will be given for 4 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with Tuberculosis who are diagnosed by medical practitioner
2. Patients with Tuberculosis who are willing to participate in the study
3. Patients with Tuberculosis who are in the ATT for at least 2 months
4. Patients with Tuberculosis with age group between 20 to 50 years
5. Patients with Tuberculosis who are in regular follow up in the TB Centre
6. Patients with primary tuberculosis
|
|
| ExclusionCriteria |
| Details |
1. Patients with Tuberculosis with comorbid illness like neurological problems and AIDS
2. Patients with Tuberculosis who are critically ill
3. Patients with Tuberculosis who are unable to follow instructions
4. Patients with Tuberculosis who are unable to take own decision making
5. Patients with Tuberculosis with active neurologic and Psychiatric problems |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Knowledge, Attitude, Practice, Pulmonary Functional Measures |
Day 1, Week 4, Week 8, Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Health Related Quality of life |
Day 1, Week 4, Week 8, Week 12 |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
11/06/2024 |
| 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="0"
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
|
The selected randomized control trial aimed to assess the effectiveness of pulmonary pulmonary
rehabilitation on knowledge, attitude, practice, pulmonary functional measures
and health related quality of life among patients with pulmonary Tuberculosis
at TB centers in Thiruvallur. The trial samples will be selected using block randomization. A total of 230 samples will be included in the study. Pre test will be done. Samples in the experimental group will undergo pulmonary rehabilitation for a period of 12 weeks. Post test will be conducted at 4, 8, 12 weeks during the pulmonary rehabilitation. Samples of control group will receive care as
usual and after the post test, pulmonary rehabilitation program will be given. The statistical significance of the trial will be evaluated.
|