| CTRI Number |
CTRI/2023/11/060260 [Registered on: 28/11/2023] Trial Registered Prospectively |
| Last Modified On: |
29/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assess physical activity and cardio-respiratory fitness in hospital house keeping staff |
|
Scientific Title of Study
|
Association between cardio respiratory fitness and physical activity of hospital house keeping staff:A cross sectional 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 |
Hetasvi Pansuriya |
| Designation |
PG Student |
| Affiliation |
Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University |
| Address |
PG Classroom, On ground Floor, Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University, Pipariya, Waghodiya, Vadodara, Gujarat-391760.
Vadodara GUJARAT 391760 India |
| Phone |
9712385553 |
| Fax |
|
| Email |
hetasvipansuriya777@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nirali Pandya |
| Designation |
Assistant Professor |
| Affiliation |
Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University |
| Address |
Staffroom,On Ground Floor,Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University, Pipariya, Waghodiya, Vadodara, Gujarat-391760.
Vadodara GUJARAT 391760 India |
| Phone |
9377845977 |
| Fax |
|
| Email |
ntpandya.pandya@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nirali Pandya |
| Designation |
Assistant Professor |
| Affiliation |
Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University |
| Address |
Staffroom,On Ground Floor,Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University, Pipariya, Waghodiya, Vadodara, Gujarat-391760.
Vadodara GUJARAT 391760 India |
| Phone |
9377845977 |
| Fax |
|
| Email |
ntpandya.pandya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
Hetasvi Pansuriya |
| Address |
PG Classroom,On Ground Floor,Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University, Pipariya, Waghodiya, Vadodara, Gujarat-391760. |
| 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 |
| Hetasvi Pansuriya |
Dhiraj Hospital |
On ground floor,409-Cardio respiratory physiotherapy OPD, Dhiraj hospital, Pipariya, Waghodiya, Vadodara, Gujarat-391760. Vadodara GUJARAT |
9712385553
hetasvipansuriya777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
26.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Both |
| Details |
-Self-declared healthy hospital house keeping staff.
-Both genders.
-People of age between 26-44 years of age group. |
|
| ExclusionCriteria |
| Details |
-House-keeping staff suffering from any physical or medical problems.
-Those who have any cardio respiratory, orthopedic, and neurological conditions.
-Not on regular medications affecting cardiovascular and respiratory system.
-The one who has recently undergone any surgeries. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Global Physical Activity Questionnaire (GPAQ)
-Queen’s college Step test |
1: Time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "85"
Final Enrollment numbers achieved (India)="85" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/12/2023 |
| Date of Study Completion (India) |
25/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Procedure for measuring physical activity level: To evaluate physical activity, GPAQ will be given to participant. Participant will fill all 16 questions about their physical activity. Evaluating physical activity MET scores will be determined independently for each domain and its subdomains. The duration of physical activity over the course of a normal week, the number of days, and the level of physical activity will all taken into consideration when calculating a categorical indicator. Questions that measure physical activity in three different behavioral domains: at work when traveling and for leisure. Low, Moderate, and High three degrees of physical activity that will identify. High: A person who engages in 1500 MET-minutes of vigorous-intense exercise over the course of three days of work (or) 3,000 MET-minutes of walking combine with moderate- or vigorous-intense activity over the course of more than a week. Moderate: Someone who does vigorous intense activity for at least 20 minutes daily for three or more days, moderate intense activity for 30 minutes daily for five or more days, or walking combine with vigorous or moderately intense activity for 600 MET minutes per week for five or more days. Low: A person who doesn’t fit the above criteria. Procedure for cardio-respiratory fitness: Age, height, and weight will be recorded along with the body mass index [BMI]. Before the test start, participants will be instructed to relax for at least five minutes. All baseline data, such as blood pressure and heart rate, will be recorded. VO2max will be indirectly determined by following the protocol of Queen’s College Step Test (QCST) method. Stepper will be used for the test. They will take four steps at a time ("up-up-down-down") on a stepper. Instruct Male participants will take step at a pace of 24 steps up per minute set by a metronome at 96 beats per minute, while female participants will take step at a rate of 22 steps up per minute set by a metronome at 88 beats per minute for a total of three minutes. After a brief time of practice and demonstration, stepping will be start. Participants will Stepping continue for 3 minutes. Radial pulse will be monitored for 15 seconds (5–20 seconds during the recovery phase) after the last step. The following equation will used to determine the maximum oxygen consumption after converting the 15-second pulse rate into beats per minute (PR x 4). Males’ VO2 max will calculate as follows: 111.33 - [0.42- pulse rate (beats/min)] [ml/Kg/min]. VO2max for females will calculate as follows: 65.81- [0.1847- pulse rate (beats/min)] [ml/Kg/min]. |