| CTRI Number |
CTRI/2024/08/073122 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation of One Minute Sit to Stand Test with Six Minute Walking Test and Physical Activity in Individuals with respiratory disease due to pulmonary tuberculosis |
|
Scientific Title of Study
|
Correlation of One Minute Sit to Stand Test with Six Minute Walk Test and Physical Activity in Individuals with Post-Tuberculosis Obstructive Airway Disease: A Cross-Sectional Study |
| 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 Rachna Arora |
| Designation |
Assistant Professor |
| Affiliation |
Topiwala National Medical College and Dr B.Y.L. Charitable Hospital |
| Address |
Room no 4,OPD 24, Physiotherapy department, PT School and Centre, Topiwala National Medical College and Dr B.Y.L.Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai,Maharashtra
Mumbai
MAHARASHTRA
400008
India |
| Phone |
7738095911 |
| Fax |
|
| Email |
rachna2arora@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rachna Arora |
| Designation |
Assistant Professor |
| Affiliation |
Topiwala National Medical College and Dr B.Y.L. Charitable Hospital |
| Address |
Room no 4,OPD 24, Physiotherapy department, PT School and Centre, Topiwala National Medical College and Dr B.Y.L.Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai,Maharashtra
Mumbai
MAHARASHTRA
400008
India |
| Phone |
7738095911 |
| Fax |
|
| Email |
rachna2arora@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kinjal Patel |
| Designation |
Post Graduate student |
| Affiliation |
Topiwala National Medical College and Dr B.Y.L. Charitable Hospital |
| Address |
Room no 4,OPD 24, Physiotherapy department, PT School and Centre, Topiwala National Medical College and Dr B.Y.L.Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai,Maharashtra
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9082080324 |
| Fax |
|
| Email |
kkp03099@gmail.com |
|
|
Source of Monetary or Material Support
|
| P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital,
Mumbai
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
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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 Rachna Arora |
P.T School & Centre, T.N.M.C & B.Y.L Ch Nair Hospital |
Room No. 4, OPD-24
(M building),
Physiotherapy
department, P.T School
& Centre, Topiwala
National Medical
College and B.Y.L. Nair
Charitable Hospital, Dr.
A.L. Nair Road, Mumbai
Central, Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
7738095911
rachna2arora@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Academic Research Projects (ECARP) PG Academic Committee T.N. Medical College and B.Y.L Nair Ch Hospital |
Approved |
|
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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 |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Post -Tuberculosis Obstructive Airway Disease individuals referred by Chest Physicians
2.Willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Active hemoptysis and Body temperature more than 100 DEGREE F
2. Uncontrolled hypertension with systolic BP more than 140 mm Hg and diastolic BP more than 90 mm Hg and resting heart rate more than 120 beats per min.
3. Resting oxygen saturation (SPO2 less than 90%)
4. Dyspnea of grade IV (Too breathless to leave the house or breathless while dressing or undressing on mMRC scale or breathless at rest)
5. Individuals with lower limb pain VAS more than 5 out of 10
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. 6 Minute Walk Distance (6MWD) in meters from 6 Minute Walk Test (6MWT)
2. Number of Sit to Stand repetitions (n) from 1 Minute Sit to Stand test (1MSTS)
3. Metabolic Equivalent (MET minutes per week) from International physical activity questionnaire – Short form (IPAQ-SF) |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
18/09/2024 |
| 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="0"
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
|
NEED OF THE STUDY
In individuals with COPD, Mjid Meriem et al, 2015 study have shown positive correlation between 1MSTS test and 6MWT but the cause is considered to be from the damage associated with cigarette smoking in developed countries. In developing countries tuberculous infection or bacterial infection are primary cause for developing obstructive airway disease. In India Brashier et al, 2007 reported an airflow obstruction prevalence of 46%, which rose in frequency over time following treatment completion. Another study by Pal et al, 2022 reported 51% individuals as having post TB COPD as a complication of TB with or without respiratory failure.
Due to pronounced inflammatory changes in pulmonary tuberculosis and structural changes within the muscle as compared to COPD due to non-infective cause, residual impairments persist post completion of disease treatment leading to increase in disease adjusted life years. This leads to increase in morbidity rate due to chronic respiratory diseases that occur as secondary complications post infection. This reduces the functional capacity of the individual which in turn reduces physical activity. With this the individual gets trapped within the vicious cycle of muscle weakness, reduction in functional capacity and physical activity.
1 Minute sit to stand test (1MSTS) is a reliable and valid alternative test to 6 Minute Walk Test (6MWT) in order to determine functional status of the individual with COPD. 1 Minute sit to stand test is also associated with peripheral muscle strength and endurance and a predictor of mortality. At times of space and time constraints, 1MSTS test can be used to assess the functional status of the individual and help determine physical activity level. Hence this study correlates 1MSTS test with 6MWT and Physical Activity in individuals with post tuberculosis obstructive airway disease.
AIM
To correlate one minute sit to stand test with six minute walk test and physical activity in individuals with post- tuberculosis obstructive airway disease.
OBJECTIVES
1. To assess number of sit to stand repetitions (n) performed in one min sit to stand test (1MSTS test) in individuals with post tuberculosis obstructive airway disease.
2. To assess six min walk test distance (6 MWD in meters) using six min walk test (6MWT) in individuals with post tuberculosis obstructive airway disease.
3. To estimate physical activity level by calculating MET minutes/ week, sitting hours and category of physical activity using International physical activity questionnaire- short form (IPAQ - SF) in individuals with post tuberculosis obstructive airway disease.
4. To correlate number of sit to stand repetitions with 6MWD, MET minutes/ week, sitting hours and category of Physical Activity in individuals with post tuberculosis obstructive airway disease.
PROCEDURE
Participants with post tb obstructive airway disease will be screened from Pulmonary medicine OPD and Physiotherapy OPD
Participants included according to inclusion criteria
Written informed consent will be filled
6 min walk test will be assessed
IPAQ - SF will be recorded during the rest period of 15 to 20 minutes
1 min sit to stand test will be assessed
Data will be analyzed
Data Management and analysis
All data obtained from the participants will be kept confidential. Both hard and soft copy will be maintained. The data will be stored in excel sheets for analysis. Graph pad or SPSS software will be used for analysis. Data will be tested for normality.
For correlation of number of sit to stand repetitions in 1 minute with 6-minute walk test distance if the data passes normality testing then Pearson’s correlation coefficient will be used for data analysis if it doesn’t pass normality testing then spearman’s correlation coefficient will be used for data analysis.
Since IPAQ-SF is a questionnaire and a non-parametric variable, correlation of number of sit to stand repetitions in 1 minute with IPAQ-SF will be done using Spearman’s correlation coefficient.
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