| CTRI Number |
CTRI/2024/07/071435 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
How simple 1-min sit-to-stand and 6-min-walk test reveal Heart ang Lung health in Interstitial Lung Disease Patients |
|
Scientific Title of Study
|
Correlation between 1-min-sit-to-stand test and 6-min-walk-test for evaluation of cardio-respiratory parameters in patients with Interstitial 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 Jaspreet Kaur |
| Designation |
Post Graduate Student |
| Affiliation |
College of Physiotherapy, Pt. B.D. Sharma PGIMS Rohtak |
| Address |
Department of Physiotherapy, E-block, College of Physiotherapy Pt. B.D. Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9466295799 |
| Fax |
|
| Email |
jaspreet733.bpt@uhsr.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gitanjali Sikka |
| Designation |
Assistant Professor |
| Affiliation |
College of Physiotherapy, Pt. B.D. Sharma PGIMS Rohtak |
| Address |
Department of Physiotherapy, E-block, College of Physiotherapy Pt. B.D. Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7027192620 |
| Fax |
|
| Email |
gsikka27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gitanjali Sikka |
| Designation |
Assistant Professor |
| Affiliation |
College of Physiotherapy, Pt. B.D. Sharma PGIMS Rohtak |
| Address |
Department of Physiotherapy, E-block, College of Physiotherapy Pt. B.D. Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7027192620 |
| Fax |
|
| Email |
gsikka27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B.D. Sharma PGIMS, Rohtak, 124001, Haryana, India |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy |
| Address |
Pt. B.D. Sharma PGIMS, Rohtak, 124001, Haryana, India |
| 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 Jaspreet Kaur |
Pt. B.D. Sharma PGIMS |
Department of Pulmonary and Critical Care Medicine (PCCM), PGIMS Rohtak, Haryana.
Rohtak
HARYANA |
9466295799
jaspreet733.bpt@uhsr.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J849||Interstitial pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1-minute-sit-to-stand |
1-min-sit-to-stand
A standard chair (height 46 cm) with no arm supports will be used. Patients will instruct to stand up from and sit down on the chair with no support from the hands, repeating the procedure as many times as possible for the duration of 1-min at a patient defined pace. The test will be first demonstrated by a staff member and then performed by the subject. The number of stands during 1-min will be determined manually.
|
| Intervention |
6-minute-walk-test |
- 6-min walk test
Patients perform the 6MWT according to the guidelines of American Thoracic Society (ATS). The 6MWT will be performed on a 30- meter track while attempting to cover as possible in the allotted 6 minutes. An experienced investigator timed the walk and record the distance travelled using standardized encouragement strategy. None of the patients used a walking aid in daily life or during the test.
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed patients with interstitial lung disease |
|
| ExclusionCriteria |
| Details |
Patients with respiratory comorbidities like COPD and lung cancer
History of acute exacerbation/respiratory infection
Unstable cardiac disease
Significant joint/musculoskeletal or neurological disease
Patients on long term oxygen therapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pulse Oximeter, Oscillo metric blood pressure measuring device, Stopwatch, 30-meter stretch walkway, Chair, Modified Borg’s Scale
|
Heart Rate, Blood Pressure, SpO2, Dyspnea |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
06/08/2024 |
| 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 Yet Recruiting |
| 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
|
Patients would be chosen from PGIMS, Rohtak’s Department of PCCM. There will be 80 patients enrolled in this trial. Participants will be randomly assigned to one of the intervention groups (Group-A/Group-B) with a 30-minute washout period using a computer-generated randomization list. All participants will take part in both therapies. All demographic information will be collected, and participants will be assessed for baseline readings (before intervention) of the cardio-respiratory parameters listed below, with values labeled "PRE-A1/ PRE-B1" based on the group in which the patient would be enrolled: - Heart rate (HR), Blood Pressure (BP), Dyspnea and SpO2 levels. Intervention A/Group A will take PRE-A1 assessments. Participants will do 6MWT. Immediately following the test, post-intervention measurements of the outcome measures listed below will be made and labeled as POST-A1 - HR, BP, SpO2 and Dyspnea. The subject will have a 15-minute break. PRE-A2 actions are planned. Participants will complete 6MWT twice. Immediately following the test, post-intervention measurements of the outcome measures listed below will be made and labeled as POST-A2 - HR, BP, SpO2, Dyspnea. The washout interval is 30 minutes. Group B/Intervention B: PRE B2 actions will be implemented. Participants will execute 1STST. The following outcome measurements will be measured after the test and labeled as POST-B1: - HR, BP, SpO2 and Dyspnea. The subject will be given 30 minutes of rest. Pre-B2 measures will be implemented. The subjects will repeat 1STST twice. Following the test, a post-intervention measurement of the outcome measures listed below will be conducted and recorded as POST-B2 - HR, BP, SpO2 and Dyspnea.
|