| CTRI Number |
CTRI/2024/07/070955 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to check Maximum phonation time can be used as a tool to find out pulmonary function in post- Covid 19 and healthy people. |
|
Scientific Title of Study
|
Is Maximum phonation time a surrogate of pulmonary function test among post COVID-19 and healthy individuals |
| 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 Minaxi PT PhD |
| Designation |
Assistant Professor |
| Affiliation |
Saket College of Physiotherapy, Chandimandir, Panchkula |
| Address |
Room No. 66, First floor
Saket College of Physiotherapy, Chandimandir, Panchkula
(Haryana)
Panchkula
HARYANA
134107
India |
| Phone |
9041095121 |
| Fax |
|
| Email |
xs4minaxi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Minaxi PT PhD |
| Designation |
Assistant Professor |
| Affiliation |
Saket College of Physiotherapy, Chandimandir, Panchkula |
| Address |
Room No. 66, First floor
Saket College of Physiotherapy, Chandimandir, Panchkula
(Haryana)
Panchkula
HARYANA
134107
India |
| Phone |
9041095121 |
| Fax |
|
| Email |
xs4minaxi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sonia |
| Designation |
Student, Masters in Physiotherapy (cardiopumonary) |
| Affiliation |
Saket College of Physiotherapy, Chandimandir, Panchkula |
| Address |
Room No. 55, Ground floor in
College rehabilitation center Saket College of
Physiotherapy, Chandimandir, Panchkula, Haryana.
Panchkula
HARYANA
134107
India
Panchkula
HARYANA
134107
India |
| Phone |
9671451149 |
| Fax |
|
| Email |
sonialakhera123@gmail.com |
|
|
Source of Monetary or Material Support
|
| address-Saket college of physiotherapy, Chandimandir Panchkula (India),134107.
Sonia, student of Saket college of physiotherapy, Chandimandir Panchkula. I will myself bear the cost of the study, |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Sonia |
Saket College of Physiotherapy, Chandimandir, Panchkula |
Room no- 55, In College rehabilitation center, Saket College of Physiotherapy, Chandimandir, Panchkula,Haryana
Panchkula
HARYANA |
9671451149
sonialakhera123@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 |
| Healthy Human Volunteers |
Preventive or screening procedure |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Both male and females
2. Post COVID-19 individuals at least after 6 months
of disease (RT PCR positive)
3. Healthy individuals ( Not infected by COVID-19) |
|
| ExclusionCriteria |
| Details |
1.Patient having any history of neurological
, orthopedic, respiratory illness other than
COVID-19, mental illness
or cardiovascular disorder which could affect study interventions and outcomes
2. Recent surgery
3. Pregnancy
4. Malignancy
5. Person who participated in singing class or
played blows instruments, professional
singers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Pulmonary functions FVC and FEV1
2)Maximum phonation time of / a / |
1) Baseline
2) After 5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
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)
|
30/07/2024 |
| 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
|
In this study ,healthy and post COVID -19 individual will be included. Each participants will be performed both procedure i.e. Maximum phonation time (MPT) and pulmonary function test (PFT).This task (MPT) will be repeated 3 times, with the gap of one minute in between the tasks. Time duration of every task will be noted and the longest duration of the attempts will be considered as MPT. The procedure of PFT will be performed according to American Thoracic Society (ATS) guidelines . MPT and PFT will be performed in gap of 5 minutes. The task ( PFT)will be repeated 3 times, gap of one minute in between the trails. Every FEV1 and FVC values will be noted and the best value out of these three trials will be taken as FEV1 and FVC. Collected data will be analyzed statistically using appropriate tests. Result. discussion and conclusion will be written accordingly. |