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临床试验/CTRI/2022/06/043060
CTRI/2022/06/043060尚未招募不适用

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.

pragna vasoya1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2022年6月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
174
试验地点
1
主要终点
systolic blood pressure, diastolic blood pressure, heart rate

研究概览

简要总结

TITLE OF STUDY

A study to comparethe effect of handgrip strengthening exercise on blood pressure and restingheart rate between normotensive and hypertensive patients – A comparativeinterventional study.

 INTRODUCTION

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

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

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

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

  NEED OF THE STUDY

â—     Some evidence indicates that greater handgrip strengthis associated with lower BP.4 In contrast, in the oldest oldpersons, higher BP was found to be associated with greater handgrip strength.6

â—     Also jogging, running and other outdoor physicalexercise reduces blood pressure. But there is no evidence suggestive ofcorrelation between handgrip strengthening exercises and blood pressure.

â—      so, need of thestudy is to compare the effect of handgrip strengthening exercise on bloodpressure between normotensive and hypertensive patients.

  AIM AND OBJECTIVES

AIM OF THE STUDY

A Study to compare the effectiveness of handgripstrengthening exercise on blood pressure, resting heart rate in normotensiveand hypertension patients.

 OBJECTIVE OF THE STUDY:

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

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

·      Tocompare the effect of handgrip strengthening exercise on blood pressure, restingHR between normotensive and hypertensive patients.

     HYPOTHESIS

Nullhypothesis:

·     Thereis no significant effect of hand grip strengthening exercise on blood pressureand resting HR in normotensive and hypertensive patients.

 Alternative hypothesis:

·     Thereis significant effect of hand grip strengthening exercise on blood pressure andresting HR in normotensive and hypertensive patients.

MATERIALS AND METHODS:

STUDY DESIGN: A comparative - interventional study

 INCLUSION CRITERIA:

·     AGE:45-60 Years

·     Bothmale and female

·     BMI:18.5 - 25 Kg/m2

·     normotensiveindividual and patients who are having essential hypertension.

·     Individualwho are willing to participate in the study

    EXCLUSION CRITERIA:

·     Subjectwith known case of any neurological condition

·     Subjectwith known case of any other cardio vascular conditions

·     Subjectwith any history of upper limb fracture or cervical radiculopathy or othermusculoskeletal disorders.

·     Minimetalscale less than 24 will be excluded.

·     Athletes

·     Thosewho are performing regular physical exercise

·     Smokersand alcohol drinker

  Materials

1.   handdynamometer

2.   MercurySphygmomanometer

3.   stethoscope

4.   Stopwatch

5.   Pen

6.   Assessmentform

7.   Consentform

8.   Paper

9.   Plinth

    METHODOLOGY:

·     Subject will be selected accordinginclusion and exclusion criteria.

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

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

·     Cardiovascular parameters like systolicblood pressure, diastolic blood pressure and heart rate Will be measured beforethe exercise after the exercise. handgrip strength will be measured by Jamarhand dynamometer before and after the exercise. SBP, DBP and HR will berecorded at the 1st day of exercise and after 1st week, after 2ndweek and 3rd week of exercise.

 OUTCOME MEASURE:

Following data will bemeasure pre and post exercise.

 Â·     Systolicblood pressure

·     Diastolicblood pressure

·     Restingheart rate

研究设计

研究类型
Interventional
分配方式
Other
盲法
Not Applicable

入排标准

年龄范围
45.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Age: 45-75 Years8
  • Both male and female
  • normotensive individual and patients who are having essential hypertension.
  • Individual who are willing to participate in the study.

排除标准

  • Subject with known case of any neurological condition
  • Subject with known case of any other cardiovascular conditions
  • Subject with any history of upper limb fracture, cervical radiculopathy and other musculoskeletal disorders disease that would restrict application of hand force.
  • Subject who are not be able to remain in sitting position while performing gripping exercise.
  • Mini mental scale less than 24 will be excluded.
  • Those who are performing regular physical exercise
  • Smokers and alcohol drinker.

结局指标

主要结局

systolic blood pressure, diastolic blood pressure, heart rate

时间窗: All will be measured at baseline, 2 WEEK, 3 week, 4 week

次要结局

  • handgrip strength, blood pressure, heart rate(handgrip strength will be taken at baseline , 2 week, 3 week , 4 week.)

研究者

发起方
pragna vasoya
申办方类型
Other [self]

研究点 (1)

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