| CTRI Number |
CTRI/2024/06/068351 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of different Exercises on Vital Signs, Oxygen intake, and Exertion Level in Young Healthy Adults 18–40 Years of Age Group |
|
Scientific Title of Study
|
Effect Of Different Exercise Regimen on Exertion Level Oxygen Consumption and Vital Parameters in Young Healthy Adults 18 to 40 years of Age group An
Observational 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 |
Mrunal Rajendrasingh Pardeshi |
| Designation |
MPT 1yr cardiovascular and respiratory Physiotherapy |
| Affiliation |
Dr.DVVPFS College Of Physiotherapy , Ahmednagar |
| Address |
Department of Cardiovascular Physiotherapy Basement
Dr Vithalrao Vikhe Patil college of physiotherapy vilad ghat Ahmednagar
MAHARASHTRA
414111
India
Department of Cardiovascular and Respiratory Physiotherapy Basement Dr Vithalrao
Vikhe Patil college of physiotherapy vilad ghat Ahmednagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414003
India |
| Phone |
07020877490 |
| Fax |
|
| Email |
mrunalpardeshi2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arijit kumar Das PT |
| Designation |
Associate professor Cardiovascular and Respiratory physiotherapy |
| Affiliation |
Dr.DVVPFS College Of Physiotherapy , Ahmednagar |
| Address |
Department of Cardiovascular and Respiratory physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy, Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India
Department of Cardiovascular and Respiratory physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy, Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9545174855 |
| Fax |
- |
| Email |
arijitdasphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arijit kumar Das PT |
| Designation |
Associate professor Cardiovascular and Respiratory physiotherapy |
| Affiliation |
Dr.DVVPFS College Of Physiotherapy , Ahmednagar |
| Address |
Department of Cardiovascular and Respiratory physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy, Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9545174855 |
| Fax |
- |
| Email |
arijitdasphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiovascular and Respiratory Physiotherapy DVVPFS College of Physiotherapy Ahmednagar |
|
|
Primary Sponsor
|
| Name |
DVVPFS College of Physiotherapy Ahmednaga |
| Address |
Department of
cardiovascular and respiratory Physiotherapy block one basement Dvvpfs College of Physiotherapy Ahmednagar MAHARASHTRA |
| Type of Sponsor |
Private 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 |
| Mrunal Pardeshi |
DVVPFS College of Physiotherapy |
Dr Vithalrao Vikhe Patil Foundations College of
Physiotherapy Opp Govt Milk dairy PO MIDC
Ahmednagar 414111
Ahmadnagar
MAHARASHTRA |
07020877490
-
mrunalpardeshi2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DVVPFS College of Physiotherapy Institutional ethical Committe Ahmednagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
none |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
young healthy adults |
|
| ExclusionCriteria |
| Details |
1)subjects diagnosed with musculoskeletal, cardiovascular,respiratory and neurological disorders which can hamper the activities to be carried out
2) subject doing regular exercise from last 1 month or more |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
VO2 max
RPE Scale
RR
HR
SPO2
|
vital parameters will be checked
pre and post, before and after every exercise |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
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)
|
16/06/2024 |
| 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
|
psychological and physiological aspects of exercise are impacted by various exercise regimen it is easier to walk on flat surface than it is to walk on treadmill or cycle ergometer, but when we consider diff exercise regimen, physiological changes may or may not be changeable. We found very few articles about physiological changes in normal adults. through this study we will be able to find out in this three-exercise regimen one can have high oxygen consumption and less extertion level. this will be used in future for rehabilitation program |