FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/06/043060 [Registered on: 07/06/2022] Trial Registered Prospectively
Last Modified On: 04/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   a study to compare the effect of handgrip strengthening exercise on blood pressure and heart rate 
Scientific Title of Study   A study to compare the effect of handgrip strengthening exercise on blood pressure and resting heart rate between normotensive and hypertensive patients – A comparative interventional study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pragna shamjibhai vasoya 
Designation  PhD scholar 
Affiliation  marwadi university, physiotherapy department 
Address  Shree K.K. Sheth Physiotherapy Collage, Rajkot, Gujarat, India
Shree K.K. Sheth Physiotherapy Collage, Rajkot, Gujarat, India
Rajkot
GUJARAT
360003
India 
Phone  9428155346  
Fax    
Email  gondaliyapragna@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  pragna shamjibhai vasoya 
Designation  PhD scholar 
Affiliation  marwadi university, physiotherapy department 
Address  Shree K.K. Sheth Physiotherapy Collage, Rajkot, Gujarat, India
Shree K.K. Sheth Physiotherapy Collage, Rajkot, Gujarat, India
Rajkot
GUJARAT
360003
India 
Phone  9428155346  
Fax    
Email  gondaliyapragna@gmail.com  
 
Details of Contact Person
Public Query
 
Name  pragna shamjibhai vasoya 
Designation  PhD scholar 
Affiliation  marwadi university, physiotherapy department 
Address  Shree K.K. Sheth Physiotherapy Collage, Rajkot, Gujarat, India
Shree K.K. Sheth Physiotherapy Collage, Rajkot, Gujarat, India
Rajkot
GUJARAT
360003
India 
Phone  9428155346  
Fax    
Email  gondaliyapragna@gmail.com  
 
Source of Monetary or Material Support  
Shree K.K. Sheth Physiotherapy Collage 
 
Primary Sponsor  
Name  pragna vasoya 
Address  Marwadi university, physiotherapy department, morbi road, PO Gavridad, Gujarat 360003 
Type of Sponsor  Other [self] 
 
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 ashish kakkad  Shree K.K. Sheth Physiotherapy Collage  Shree K.K. Sheth Physiotherapy Collage, Rajkot, Gujarat, India
Rajkot
GUJARAT 
9824415797

ashish.kakkad@marwadieducation.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shree Giriraj hospital research ethics committee  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 
Intervention  handgrip strengthening exercise   I will take blood pressure and resting heart rate and handgrip strength in patients with hypertension and in normotensive subjects. Hand grip strengthening exercise training for 30 minutes, 1 session per day ,5 days a week, for 4 weeks.  
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Age: 45-75 Years8
2. Both male and female
3. normotensive individual and patients who are having essential hypertension.
4. Individual who are willing to participate in the study
 
 
ExclusionCriteria 
Details  1. Subject with known case of any neurological condition
2. Subject with known case of any other cardiovascular conditions
3. Subject with any history of upper limb fracture, cervical radiculopathy and other musculoskeletal disorders disease that would restrict application of hand force.
4. Subject who are not be able to remain in sitting position while performing gripping exercise.
5. Mini mental scale less than 24 will be excluded.
6. Athletes
7. Those who are performing regular physical exercise
8. Smokers and alcohol drinker

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
systolic blood pressure, diastolic blood pressure, heart rate  All will be measured at baseline, 2 WEEK, 3 week, 4 week 
 
Secondary Outcome  
Outcome  TimePoints 
handgrip strength, blood pressure, heart rate  handgrip strength will be taken at baseline , 2 week, 3 week , 4 week. 
 
Target Sample Size   Total Sample Size="174"
Sample Size from India="174" 
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)   15/06/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

TITLE OF STUDY

A study to compare the effect of handgrip strengthening exercise on blood pressure and resting heart rate between normotensive and hypertensive patients – A comparative interventional study.

 

INTRODUCTION

Hypertension, also known as high or raised blood pressure, is a condition in which the blood vessels have persistently raised pressure. Blood is carried from the heart to all parts of the body in the vessels. Each time the heart beats, it pumps blood into the vessels. Blood pressure is created by the force of blood pushing against the walls of blood vessels (arteries) as it is pumped by the heart. The higher the pressure, the harder the heart has to pump. (According to WHO)

High blood pressure (BP) is ranked as the third most important risk factor for attributable burden of disease in south Asia. Hypertension exerts a substantial public health burden on cardiovascular health status and healthcare systems in India. Hypertension is directly responsible for 57% of all stroke deaths and 24% of all coronary heart disease deaths in India. The WHO rates Hypertension as one of the most important causes of premature death worldwide. one-third of urban adult Indians and close to one fourth of rural adult Indians are hypertensive.1

An early and a regular screening to detect underlying hypertension is necessary to prevent any future complications. Prevalence of hypertension is increasing rapidly among Indians. Rapid urbanization, sedentary life style, junk food and stress are the powerful environmental risk factors for increasing prevalence of hypertension, especially in younger age group. Hypertension is a major risk factor for cardiovascular diseases like myocardial infarction, stroke. Hypertension is a controllable disease, early diagnosis and control can prevent 300,000 of 1.5 million deaths from cardiovascular diseases in India. Lifestyle modifications like increased physical activity, salt restriction and weight reduction are effective for prevention and treatment of hypertension. Exercise being the integral component of therapy. Regular exercise has been shown to be effective in reducing the risks of hypertension. It is an important intervention to prevent and treat hypertension.2

Hypertension is a serious medical condition. It markedly increases the risk of cardiovascular diseases and overall mortality. Lifestyle modifications, such as increased levels of physical activity, are recommended as the first line of anti-hypertensive treatment.

 

 

NEED OF THE STUDY

 

●     Some evidence indicates that greater handgrip strength is associated with lower BP.4 In contrast, in the oldest old persons, higher BP was found to be associated with greater handgrip strength.6

●     Also jogging, running and other outdoor physical exercise reduces blood pressure. But there is no evidence suggestive of correlation between handgrip strengthening exercises and blood pressure.

●      so, need of the study is to compare the effect of handgrip strengthening exercise on blood pressure between normotensive and hypertensive patients.

 

 

 

AIM AND OBJECTIVES

 

AIM OF THE STUDY

A Study to compare the effectiveness of handgrip strengthening exercise on blood pressure, resting heart rate in normotensive and hypertension patients.

 

OBJECTIVE OF THE STUDY:

·      To find out the effect of hand grip strengthening exercise on blood pressure, resting HR in normotensive patients.

·      To find out the effect of hand grip strengthening exercise on blood pressure, resting HR in patient with essential hypertension.

·      To compare the effect of handgrip strengthening exercise on blood pressure, resting HR between normotensive and hypertensive patients.

 

 

 

 

 

HYPOTHESIS

Null hypothesis:

·      There is no significant effect of hand grip strengthening exercise on blood pressure and resting HR in normotensive and hypertensive patients.

 

Alternative hypothesis:

·      There is significant effect of hand grip strengthening exercise on blood pressure and resting HR in normotensive and hypertensive patients.

 

MATERIALS AND METHODS:

 

STUDY DESIGN: A comparative - interventional study

 

INCLUSION CRITERIA:

·      AGE: 45-60 Years

·      Both male and female

·      BMI: 18.5 - 25 Kg/m2

·      normotensive individual and patients who are having essential hypertension.

·      Individual who are willing to participate in the study

 

 

 

 

EXCLUSION CRITERIA:

·      Subject with known case of any neurological condition

·      Subject with known case of any other cardio vascular conditions

·      Subject with any history of upper limb fracture or cervical radiculopathy or other musculoskeletal disorders.

·      Minimetal scale less than 24 will be excluded.

·      Athletes

·      Those who are performing regular physical exercise

·      Smokers and alcohol drinker

 

 

 Materials

1.    hand dynamometer

2.    Mercury Sphygmomanometer

3.    stethoscope

4.    Stop watch

5.    Pen

6.    Assessment form

7.    Consent form

8.    Paper

9.    Plinth

 

 

 

 

METHODOLOGY:

·      Subject will be selected according inclusion and exclusion criteria.

·      Sample size will be calculated from prevalence rate or from previous study has been done on hypertension.

·      The purpose of the study was explained to the subjects and a written informed consent was obtained. Total 50 healthy normotensive and 50 patients with essential hypertension will be chosen as subjects and their baseline blood pressure and resting HR will be recorded. The subjects are asked to perform the handgrip exercise of for 10 minutes for 3 weeks. after the exercise, the blood pressure will be recorded from the exercising arm. The blood pressure will be recorded again 3 minutes after the exercise.

·      Cardiovascular parameters like systolic blood pressure, diastolic blood pressure and heart rate Will be measured before the exercise after the exercise. handgrip strength will be measured by Jamar hand dynamometer before and after the exercise. SBP, DBP and HR will be recorded at the 1st day of exercise and after 1st week, after 2nd week and 3rd week of exercise.

 

OUTCOME MEASURE:

Following data will be measure pre and post exercise.

 

·      Systolic blood pressure

·      Diastolic blood pressure

·      Resting heart rate

 

 

 
Close