| CTRI Number |
CTRI/2025/07/091572 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Assessment of Cardiorespiratory Responses to Various Functional Capacity Tests in Healthy Adults |
|
Scientific Title of Study
|
Comparison of the effect of various functional capacity tests on
cardiorespiratory parameters in 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 |
Mrinalee Jain |
| Designation |
Post Graduate Student |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
College of Physiotherapy,
Medical Road
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8368954183 |
| Fax |
|
| Email |
mrinaleej@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gitanjali Sikka |
| Designation |
Associate Professor |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
College of Physiotherapy, Medical Road
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
07027192620 |
| Fax |
|
| Email |
gsikka27@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mrinalee Jain |
| Designation |
Post Graduate Student |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
College of Physiotherapy, Medical Road
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8368954183 |
| Fax |
|
| Email |
mrinaleej@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak, 124001, Haryana, India |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy |
| Address |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, 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 Mrinalee Jain |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
College of Physiotherapy
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Medical Road
Rohtak -124001
Rohtak
HARYANA |
8368954183
mrinaleej@gmail.com |
|
|
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 |
| Healthy Human Volunteers |
Subjects must not with problems of visual and hearing communication
Subjects with no cognitive dysfunction.
Subjects diagnosed with no cardiopulmonary, vascular or musculoskeletal problem that
precluded their walking, standing from chair or climbing steps |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Subjects able to walk 6 meters without an assistive device
Subjects who are non-smoker and non-drinker
Subjects who fully understood the test and decided to participate of their own free will and agreed with the written consent document.
|
|
| ExclusionCriteria |
| Details |
Subjects having with problems of visual and hearing communication
Subjects with cognitive dysfunction
Subjects diagnosed with cardiopulmonary, vascular or musculoskeletal problem that precluded their walking, standing from chair or climbing steps
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart rate
Saturation of Peripheral Oxygen
Delta Heart Rate
Delta SpO2
Blood Pressure
Delta Blood Pressure
Rate of Perception Excretion |
Pre test
Post test
After 1 minute
After 3 minute |
|
|
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)
|
11/08/2025 |
| 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
|
A total of 250 healthy individuals from the Department of Physiotherapy will be screened based on inclusion and exclusion criteria. Informed consent will be obtained after explaining the purpose and procedures of the study. Each subject will be evaluated in a single day. Initially, demographic details and baseline measurements (heart rate, blood pressure, SpO2) will be recorded and marked as ‘Pre’. Participants will then perform five functional capacity tests—2-Minute Step Test (2MST), 2-Minute Walk Test (2MWT), 3-Minute Walk Test (3MWT), 10-repetition Sit-to-Stand Test (STS10), and 60-second Sit-to-Stand Test (STS60)—in a randomized order using a computer-generated list, with a 10-minute washout period between tests.Post-test measurements, including heart rate, blood pressure, SpO2, Rating of Perceived Exertion (RPE), number of steps (2MST), distance covered (2MWT and 3MWT), repetitions (STS60), and time taken (STS10), will be recorded at specified intervals and marked as ‘Post’. All participants will perform all five tests. |