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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  
Dhiraj Hospital,Vadodara 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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].

 
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