| CTRI Number |
CTRI/2025/07/090008 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal Panel study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of various cardio respiratory parameters in young post covid individuals A longitudinal panel study |
|
Scientific Title of Study
|
Evaluation of various cardio respiratory parameters in young post covid individuals A longitudinal panel 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 |
Rupareliya vaidikkumar Pravinbhai |
| Designation |
PhD Scholar |
| Affiliation |
SPB Physiotherapy college surat |
| Address |
604 satyam appartment arpit bafna society station road bardoli
SPB physiotherapy college Mora bhagal Ugat bhesan road surat
Surat
GUJARAT
394601
India |
| Phone |
8780279268 |
| Fax |
|
| Email |
vaidikrupareliya111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rupareliya vaidikkumar Pravinbhai |
| Designation |
PhD Scholar |
| Affiliation |
SPB Physiotherapy college surat |
| Address |
604 satyam appartment arpit bafna society station road bardoli
SPB physiotherapy college Mora bhagal Ugat bhesan road surat
Surat
GUJARAT
394601
India |
| Phone |
8780279268 |
| Fax |
|
| Email |
vaidikrupareliya111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prakash Patel |
| Designation |
Associate professor |
| Affiliation |
SPB Physiotherapy college |
| Address |
SPB Physiotherapy college mora bhagal ugat bhesan road surat
SPB Physiotherapy college mora bhagal ugat bhesan road surat
Surat
GUJARAT
395005
India |
| Phone |
7874512423 |
| Fax |
|
| Email |
dr.prakash84@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SPB Physiotherapy college Surat |
| Address |
SPB physiotherapy college Mora bhagal Ugat bhesan road surat |
| Type of Sponsor |
Other [private physiotherapy college] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrPrakash Patel |
SPB physiotherapy college Mora bhagal Ugat bhesan road surat |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prakash Patel |
SPB physiotherapy college |
SPB Physiotherapy college mora bhagal ugat bhesan road surat
Surat
GUJARAT |
7874512423
dr.prakash84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGMERC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: U071||COVID 19 virus identified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Day(s) |
| Age To |
35.00 Day(s) |
| Gender |
Both |
| Details |
Young post covid individuals
Individuals with RTPCR/ CT scal report for confirmatory diagnosis
|
|
| ExclusionCriteria |
| Details |
Tobbacco chewing & smoking individuals
Obese class II and III
Any other musculoskeletal and neurological and Cardiorespiratoty issue. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
VO2 max
Heart rate reserve
Post exertional malaise |
VO2 max
Heart rate reserve
Post exertional malaise |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
15/07/2025 |
| 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
|
we will recruite post covid individuals for the study to assess the VO2 max heart rate reserve & post exertional malaise and evlaute the following parameters in two phase of the study initial evaluation and after the 6 month evaluation. |