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CTRI Number  CTRI/2024/05/066794 [Registered on: 06/05/2024] Trial Registered Prospectively
Last Modified On: 03/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Which Pilates Technique will be effective in the primary hypertension? 
Scientific Title of Study   Immediate Effect Of Various Technique Of Pilates on vital parameters in individuals with Primary Hypertension: Crossover 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  Rutuja Pusegaonkar 
Designation  Cardiovascular and respiratory Post Graduate Resident 
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy 
Address  1st floor,Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy, 11/12 Thube Park, Shivajinagar, Pune Pune MAHARASHTRA 411005 India

Pune
MAHARASHTRA
411005
India 
Phone  9011168405  
Fax    
Email  pusegaonkarrutuja@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jahnvi Panwar 
Designation  Associate professor 
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy 
Address  1st floor,Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy, 11/12 Thube Park, Shivajinagar, Pune Pune MAHARASHTRA 411005 India

Pune
MAHARASHTRA
411005
India 
Phone  9396604972  
Fax    
Email  jahnvip4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rutuja Pusegaonkar 
Designation  Cardiovascular and respioratory physiotherapy Post Graduate Resident 
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy 
Address  1st floor,Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy, 11/12 Thube Park, Shivajinagar, Pune Pune MAHARASHTRA 411005 India

Pune
MAHARASHTRA
411005
India 
Phone  9011168405  
Fax    
Email  jahnvip4@gmail.com  
 
Source of Monetary or Material Support  
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy, 11/12 Thube Park, Shivajinagar, Pune Pune MAHARASHTRA 411005 India 
 
Primary Sponsor  
Name  Rutuja Pusegaonkar 
Address  Sancheti Institute Orthopedics and Rehabilitation College of Physiotherapy,11/12 Thube park, shivajinagar,pune-411005 
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 
Dr Rutuja Pusegaonkar  Sancheti Institute Orthopedics and Rehabilitation College of Physiotherapy  1st floor, Sancheti Institute Orthopedics and Rehabilitation College of Physiotherapy,11/12 Thube park, shivajinagar,pune-411005
Pune
MAHARASHTRA 		 9011168405

jahnvip4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I00-I99||Diseases of the circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CardioPilates  Warm up Breathing exercises Neck movements Shoulder movements Hip rotation movement Protocol Jumping jacks 10 reps High knees 10 reps Heel lift 10 reps Table top 10 reps Toe tap 10 reps Single leg stretch 10 reps Cool down Breathing exercise Stretching savasana warm up 10 mins protocol 30 mins cooldown 10 mins 
Intervention  Chair Pilates  Warm up Breathing exercises Neck movements Shoulder movements Hip rotation movement Protocol Seated marches 10 reps Spine twist 10 reps Seated scissor leg 10 reps Seated single leg stretch 10 reps Seated Roll down 10 reps Seated side bend 10 reps Cool down Breathing exercise Stretching savasana warm up 10 mins protocol 30 mins cooldown 10 mins 
Intervention  Mat Pilates  Warm up Breathing exercises Neck movements Shoulder movements Hip rotation movement Protocol Table top 10reps Toe tap 10 reps Single leg stretch 10 reps Side kick 10 reps Swan dive 10 reps Bridging 10 reps Cool down Breathing exercise Stretching savasana warm up 10 mins protocol 30 mins cooldown 10 mins 
Comparator Agent  Mat Pilates CardioPilates Chair Pilates  Comparing all the three interventions with each other warm up 10 mins protocol 30 mins cooldown 10 mins 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Primary Hypertension diagnosed by the Physician
On antihypertensive medication 
 
ExclusionCriteria 
Details  Pregnancy
Patient present with any cardiac, chronic kidney disease, stroke within past year, orthopaedic problem & respiratory problem
Patient on beta-blocker 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Heart Rate
Blood Pressure 		 The outcome will be assessed before the every interventation and after the interventation
 
 
Secondary Outcome  
Outcome  TimePoints 
Modified Borg Scale  The outcome will be assessed before the every interventation & after the interventation
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/05/2024 
Date of Study Completion (India) 22/04/2025 
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 Yet Recruiting 
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   Pilates exercise contibute to the blood pressure management in the primary Hypertension population. Understanding the impact on vital parameters such as blood pressure, heart rate, can help in identifying the potential benefits or risk associated with specific pilates exercise. Mat pilates has proven to be effective intervention in the primary hypertension population. The cardiopilates refers to the fusion of the cardiovascular exercise principle with pilates techniques. It aims to combine the core strengthening & flexibility aspect of pilates with the cardiovascular benefits of aerobic exercise. The chair pilates is modified form of pilates that adapts pilates exercises to be performed while seated on a chair. This variation makes pilates more accessible especially for individuals who have difficulty with the exercises on the mat or floor. This study is to compare the effect of mat pilates, cardiopilates &  chair pilates on the vital parameters in the individuals with the primary hypertension.  
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