| 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
|
|
|
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
|
|
|
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. |