| CTRI Number |
CTRI/2025/10/095747 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study tries to find out if doing pilates exercises can help middle aged people react faster and feel better in their daily life
the study looks at how pilates affects simple reaction time which means how quickly someone responds to things and quality of life |
|
Scientific Title of Study
|
Effectiveness of Pilates on Simple Reaction Time and Quality of Life in Middle Age Population a Experimental 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 |
Prajkta Kedar |
| Designation |
Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Room No 201 Neuro Opd Second Floor Parul Sevashram Hospital Parul University PO Limda TAL.Waghodia DIST.Vadodara Room No 201 Neuro Opd Second Floor Parul Sevashram Hospital Parul University PO Limda TAL.Waghodia DIST.Vadodara Vadodara GUJARAT 391760 India |
| Phone |
9326038713 |
| Fax |
|
| Email |
prajktaaavk@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr jigisha vaniya |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Room No 201 Neuro Opd Second Floor Parul Sevashram Hospital Parul University PO Limda TAL.Waghodia DIST.Vadodara Room No 201 Neuro Opd Second Floor Parul Sevashram Hospital Parul University PO Limda TAL.Waghodia DIST.Vadodara Vadodara GUJARAT 391760 India |
| Phone |
8200070593 |
| Fax |
|
| Email |
jigishavaniya95@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prajkta Kedar |
| Designation |
Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Room No 201 Neuro Opd Second Floor Parul Sevashram Hospital Parul University PO Limda TAL.Waghodia DIST.Vadodara Room No 201 Neuro Opd Second Floor Parul Sevashram Hospital Parul University PO Limda TAL.Waghodia DIST.Vadodara Vadodara GUJARAT 391760 India |
| Phone |
9326038713 |
| Fax |
|
| Email |
prajktaaavk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul sevashram hospital waghodia limda 391760 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Prajkta Kedar |
Parul Sevashram Hospital |
Room No 201 Neuro Opd Second Floor Parul Sevashram Hospital Parul University PO Limda TAL.Waghodia DIST.Vadodara Vadodara GUJARAT |
9326038713
prajktaaavk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Committee for Human Research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Middle aged individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy Exercises 4 Weeks 4 Days Per Week |
Ball and Catch Exercise
Range of Motion Exercise for Both Upper and Lower Limb
Walking
|
| Intervention |
Pilates exercise 4 Weeks 4 Days Per Week |
Breathing Exercises
Imprint and Release
Spinal Rotation
Cat Stretch
Mat Exercises
Standing Side Bends
Calf Strengthener
Spine Stretch
Low Back Stretch
Shoulder Bridge
elastic bands
Standing Extension Exercises
Long Sitting Ankle Plantar Flexion
Shoulder Flexion to 90 Degrees
Shoulder Abduction to 90 Degrees
Biceps Curls
Pilates Ball
Seated Bounce on Ball
Seated Leg Rotation
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group 40-60 years
Willingness to participate in the study
Ability to commit to the Pilates training program
Individuals without any disorder |
|
| ExclusionCriteria |
| Details |
Pregnant females
Highly active individual or athletes
Simultaneous participation in other rehabilitation program during study period |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Ruler drop test |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SF-36 questionnaire |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
03/11/2025 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
As the global population continues to age, middle-aged individuals (typically aged 40-60) often experience a decline in both physical and cognitive functions, which can significantly impact their overall well-being and quality of life. In particular, simple reaction time (SRT)—the time it takes to respond to a stimulus—is known to be a key indicator of cognitive performance. people age, cognitive processing, including SRT, tends to slow down, potentially leading to challenges in everyday functioning and decision-making. This decline in reaction time can be particularly detrimental to individuals in middle age, affecting their ability to perform tasks quickly and efficiently. As the global population continues to age, middle-aged individuals (typically aged 40-60) often experience a decline in both physical and cognitive functions, which can significantly impact their overall well-being and quality of life. In particular, simple reaction time (SRT)—the time it takes to respond to a stimulus—is known to be a key indicator of cognitive performance This study aims to explore how regular Pilates practice influences simple reaction time and quality of life in middle-aged adults. |