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CTRI Number  CTRI/2022/01/039346 [Registered on: 12/01/2022] Trial Registered Prospectively
Last Modified On: 09/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical trial to study the effects of low versus high intensity isometric handgrip exercise training on reduction of blood pressure in individuals with high blood pressure 
Scientific Title of Study   The impact of low versus high intensity isometric handgrip exercise training on reduction of blood pressure in individuals with hypertension- A randomized double-blinded controlled trial 
Trial Acronym  IHG-HTN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vidhi Thakar 
Designation  Assistant Professor 
Affiliation  Ashok and Rita Patel Institute of Physiotherapy 
Address  Room 112 Department of Cardiopulmonary Physiotherapy Ground floor Ashok and Rita Patel Institute of Physiotherapy Charotar University of Science and Technology Changa Taluka Petlad

Anand
GUJARAT
388421
India 
Phone  9426778772  
Fax    
Email  vidhithakar.phy@charusat.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Vidhi Thakar 
Designation  Assistant Professor 
Affiliation  Ashok and Rita Patel Institute of Physiotherapy 
Address  Room 112 Department of Cardiopulmonary Physiotherapy Ground floor Ashok and Rita Patel Institute of Physiotherapy Charotar University of Science and Technology Changa Taluka Petlad

Anand
GUJARAT
388421
India 
Phone  9426778772  
Fax    
Email  vidhithakar.phy@charusat.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Dharmishtha Kharva 
Designation  Post Graduate student 
Affiliation  Ashok and Rita Patel Institute of Physiotherapy 
Address  Room 112 Department of Cardiopulmonary Physiotherapy Ground floor Ashok and Rita Patel Institute of Physiotherapy Charotar University of Science and Technology Changa Taluka Petlad

Anand
GUJARAT
388421
India 
Phone  7984281635  
Fax    
Email  20MPTCS103@charusat.edu.in  
 
Source of Monetary or Material Support  
Ashok and Rita Patel Institute of Physiotherapy Charotar University of Science and Technology Changa 
 
Primary Sponsor  
Name  Dr Vidhi Thakar 
Address  Room 112 Department of Cardiopulmonary Physiotherapy Ground floor Ashok and Rita Patel Institute of Physiotherapy Charotar University of Science and Technology Changa Taluka Petlad District Anand 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Dharmishtha Kharva  Room 112 Department of Cardiopulmonary Physiotherapy Ground floor Ashok and Rita Patel Institute of Physiotherapy Charotar University of Science and Technology Changa Taluka Petlad District Anand 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vidhi Thakar  Charusat hospital  OPD 2 Charusat University campus Changa Taluka Petlad
Anand
GUJARAT 		 9426778772

vidhithakar.phy@charusat.ac.in 
Dr Vidhi Thakar  Sheth H J Mahagujarat Hospital   OPD 2 College Road Nadiad
Kheda
GUJARAT 		 9426778772

vidhithakar.phy@charusat.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee CHARUSAT  Approved 
Institutional Ethics Committee CHARUSAT  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Isometric Handgrip (IHG) exercise training  Group A 5% Maximum Voluntary Contraction (MVC) IHG Dose Bilaterally 4 sets of 5% MVC contractions with 2 min hold and 1 min interval in between each contraction, 3 alternative days per week for 4 weeks Home training programme 
Intervention  Isometric Handgrip (IHG) exercise training   Group B 30% Maximum voluntary contraction (MVC) IHG Dose Bilaterally 4 sets of 30% MVC contractions with 2 min hold and 1 min interval in between each contraction 3 alternative days per week for 4 weeks Home training programme 
Intervention  Isometric Handgrip (IHG) exercise training  Group C 90% Maximum voluntary contraction (MVC) IHG Dose Bilaterally 32 contractions of 90% MVC with 5 sec hold and 5 sec rest interval in between each contraction 3 alternative days per week for 4 weeks Home training programme  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Having resting systolic blood pressure between 130 to 159 mmHg and diastolic blood pressure of 85 to 99 mmHg (As per International Society of Hypertension)

Individual not taking antihypertensive medication or either taking antihypertensive medication with no change in medication for past 4 months
 
 
ExclusionCriteria 
Details  Individuals with resting blood pressure greater than or equal to 160/100 mm Hg

Individual with cardiovascular diseases (coronary artery disease, heart failure, peripheral vascular diseases), kidney disease or any cerebrovascular diseases

Individual with any type of Diabetes mellitus

Any physical limitations or disabilities of hand (e.g.: - Upper limb amputation)

Individuals with severe arthritis of hand, carpal tunnel syndrome or cervical radiculopathy

Individual taking more than three blood pressure regulating medications

Individual who are participant of any exercise program or are physically active i.e., walking or pranayama techniques (3 days/week for past 3 months)

Individual with cognitive deficit or difficulty in understanding or mental health issues
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Systolic blood pressure and Diastolic blood pressure  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Exercise adherence   1st week
2nd week
3rd week
4th week 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/01/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vidhithakar.phy@charusat.ac.in].

  6. For how long will this data be available start date provided 01-02-2024 and end date provided 31-12-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is randomized, double blinded, parallel group, multiple arm trial comparing the effects of low [5% MVC (control), 30% MVC (intervention)] versus high [90% MVC (intervention)] intensity isometric handgrip exercise training for 3 alternative days/week for 4 weeks on reduction of blood pressure in individuals with hypertension which will be conducted as a home exercise training programme. The primary outcome measure will be the systolic and diastolic blood pressure change from before and after 4 weeks of Isometric handgrip exercise training. 
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