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CTRI Number  CTRI/2024/11/076786 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 13/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Effect of small bouts of exercise on fitness of sedentary desk job workers 
Scientific Title of Study   Enhancing health and fitness in sedentary desk job workers - A comprehensive workplace exercise intervention  
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aishwarya Abhay Deo 
Designation  Master of physiotherapy student  
Affiliation  SVKMs NMIMS, Sunandan Divitia school of science 
Address  Room no. 27, 3rd floor, Hedavkar wadi no.1, Gokhale road south Dadar, Mumbai -400028

Mumbai
MAHARASHTRA
400028
India 
Phone  07738317378  
Fax    
Email  aishdeo@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Poonam Parulekar  
Designation  Assistant Professor  
Affiliation  SVKMs NMIMS, Sunandan Divitia school of science 
Address  Sunandan Divitia School of Science, 7th floor, SVKMs Mithibai college, Vile Parle west.

Mumbai
MAHARASHTRA
400056
India 
Phone  9821820233  
Fax    
Email  Poonam.Parulekar@nmims.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Poonam Parulekar  
Designation  Assistant Professor  
Affiliation  SVKMs NMIMS, Sunandan Divitia school of science 
Address  Sunandan Divitia School of Science, 7th floor, SVKMs Mithibai college, Vile Parle west.


MAHARASHTRA
400056
India 
Phone  9821820233  
Fax    
Email  Poonam.Parulekar@nmims.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Ground floor Nanavati Max Super Specialty Hospital SV Road Vile Parle west, Mumbai, Maharashtra 400056 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [] 
 
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 
Dr Poonam Parulekar  Dr. Balabhai Nanavati, super speciality hospital   Department of Physiotherapy, Ground floor Nanavati Max Super Specialty Hospital SV Road Vile Parle west, Mumbai, Maharashtra 400056
Mumbai
MAHARASHTRA 
9821820233

Poonam.Parulekar@nmims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics commitee, Dr. Balabhai Nanavti Hospital Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Sedentary Desk Job Workers  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  acute exercise bouts   stretching exercises 2 added on every week. breathing exercises added every week. 5-6 minutes of simple endurance activities, changed every week. simple games and tasks taken as group activities twice a week [ includes reinforcement of the daily exercises and games] Total intervention for 6 weeks group sessions - 2 times/ week individual sessions - 5 days/ week [ including grp sesssions]  
Comparator Agent  not applicable   not applicable  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  49.00 Year(s)
Gender  Both 
Details  1. Full-time sedentary desk job workers.
2. Category levels 1& 2 on an IPAQ questionnaire, with low and moderate levels of physical activity respectively.
 
 
ExclusionCriteria 
Details  1. Individuals with pre-existing medical conditions that may affect flexibility, endurance, or respiratory function, such as musculoskeletal disorders, cardiovascular diseases, or respiratory conditions.
2. Pregnant women.
3. Recent major surgery or hospitalization within the last three months.
4. People who work remotely on a full-time basis.
5. People with any co-morbidities like – diabetes, hypertension etc 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
YMCA step test - Heart rate   pre & after 6 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
myocardial Oxygen Consumption
 
pre and post YMCA step test  
vital capacity -Inspiratory spirometer  post 6 weeks of intervention 
Health status
NIOSH worker wellbeing questionnaire [Section 4 – Health Status]
 
pre and post 6 weeks 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   24/11/2024 
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 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  

In my study, titled "Enhancing Health and Fitness in Sedentary Desk Job Workers," I aim to explore the impact of a structured workplace exercise program on cardiopulmonary endurance, vital capacity, and overall health among adults aged 30 to 49 with sedentary desk jobs. With a large portion of the workforce in service sectors, prolonged sitting has become a serious health risk, often contributing to decreased productivity, absenteeism, and even mental health impacts. Recognizing this from my review of the literature, my study addresses the need for proactive health measures directly in the workplace. I have acquired the ethical committee approval letter from the Ethics Committee of Dr. Balabhai Nanavati Hospital Mumbai

The study is a quasi-experimental study with 45 participants who will take part in a 6-week program. This program includes both individual sessions that work on components like stretching, endurance exercises, and breathing exercises, and group sessions that help with team building and improving the mental well-being of the participants. Participants will undergo assessments for endurance, and vital capacity, and the health status questionnaire before and after the program. I’ll be analyzing the data using SPSS, with a significance level set at p < 0.05 to understand the program’s impact. This research has the potential to present a practical, time-efficient solution for improving health outcomes among desk job workers without requiring additional gym time or resources.

 
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