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临床试验/CTRI/2025/07/091281
CTRI/2025/07/091281尚未招募不适用

Effect of planned physical activity module on adult with hypertension in rural Telangana- Community Based intervention Trial

Dr Venkatesh1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月31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
100
试验地点
1
主要终点
average change of blood pressure in adult

研究概览

简要总结

PROJECT SUMMARY

Background: Hypertension is a preventable and modifiable risk factor for cardiovascular disease (stroke and coronary heart disease), According to WHO, estimated 1.28 billion adults aged 30-79 years worldwide have hypertension and 2/3rd live in low and middle income countries.Estimated 46% of adults with hypertension are unaware about their condition and only 42% of those diagnosed avail treatment(3)physical inactivity is believed to be responsible for 5% to 13% of hypertension(6)Meta-analysis 2018 in east Asians suggests aerobic fitness training decreases blood pressure approximately 4.7mmHg systolic and 3.2 mm Hg diastolic blood pressure in people with mild to moderate hypertension (7) 5mmHg reduction SBP in the population leads to overall reduction of 14% mortality due to stroke, 9% reduction in mortality due to coronary heart disease and 7% reduction in all cause of mortality (8)The national prevalence of hypertension is estimated to be 18.3%; men (21.6%) and women (14.8%)(4)In Telangana it is 26.1% in women and 31.4% among men(5)

Objectives

: Aim: To study the effect of a Planned  Physical Activity Module on the average blood pressure adult with hypertension on oral anti-hypertensive

Primary objective: To measure an average change of blood pressure in adult hypertensive on PPAM compared to control group.

Secondary objective: i ii To evaluate the effectiveness of health education intervention in increasing physical activity profile of persons with hypertension. To evaluate the acceptability of the PPAM module iii To identify the change in drug intake pattern in the intervention group compared to the control group

Methods: A community based interventional study will be conducted at field practice area of AIIMSBibinagar (Bibinagar and Bommalaramaram),between September 2024 and december 2025. To evaluateeffect of planned  physical activity module on the adult hypertensive patients in rural Telangana. Eligible subjects within the inclusion and exclusion criteria , will be explained about the study and information sheet would be provided to them to make them understand the participation and purpose of the study. Base line blood pressure of Bibinagar(intervention group)and Bommalaramaram (control group ) are measured and introduction of PPPAM in the intervention group and control group followed without any intervention over 9 months,end line bp measured and data analysis done .

Expected outcomes: • Mean change in average BP of the intervention group v/s control group • Proportion of persons adhering to the PPAM • Acceptability of the PPAM

研究设计

研究类型
Interventional
分配方式
Na

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adult patient with hypertension(30-65 years), diagnosed at least 12 months prior to the study who are on oral anti-hypertensives.
  • Systolic BP 120-140 mmHg and Diastolic BP 80-90 mmHg as measured as average of last 2 out of 3 readings measured on the date of the recruitment survey.
  • Residing in the study setting for a minimum duration of 12 months.

排除标准

  • Persons with any other comorbidities’ like diabetes mellitus, neuro musculoskeletal disorder, disorders renal and CVS and pregnancy Persons with physical disability, previous diagnosis of intellectual disability or mental health disorder who are unable to comprehend the contents of the module.

结局指标

主要结局

average change of blood pressure in adult

时间窗: at a monthly interval for 12 months , the participiants are checked for blood pressure and physical activity profile

hypertensives on PPAM compared to control group. erage change of blood pressure in adult

时间窗: at a monthly interval for 12 months , the participiants are checked for blood pressure and physical activity profile

hypertensive on PPPAM compared to control group.

时间窗: at a monthly interval for 12 months , the participiants are checked for blood pressure and physical activity profile

次要结局

  • at a monthly interval for 12 months , the participants are checked for average blood pressure changes(at monthly interval for 12 months)

研究者

发起方
Dr Venkatesh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Venkatesh

AIIMS BIBINAGAR

研究点 (1)

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