| CTRI Number |
CTRI/2025/07/091281 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [HEALTH EDUCATION ABOUT PHYSICAL ACTIVITY ] |
| Study Design |
Other |
|
Public Title of Study
|
effect of health education about physical activity throgh a planned physical activy module in adult with hypertension in rural telangana |
|
Scientific Title of Study
|
Effect of planned physical activity module on adult with hypertension in rural Telangana- Community Based intervention
Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Venkatesh |
| Designation |
junior resident |
| Affiliation |
AIIMS BIBINAGAR |
| Address |
Department of Community Medicine and Family Medicine, academic block, AIIMS Bibinagar, HMR, yadadri bhuvangiri district, telangana.
Department of Community Medicine and Family Medicine, academic block, AIIMS Bibinagar, HMR, yadadri bhuvangiri district, telangana.
Nalgonda
TELANGANA
508126
India |
| Phone |
8073177371 |
| Fax |
|
| Email |
DR.VENKATESHPOBBATHI3@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RASHMI KUNDAPUR |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
AIIMS BIBINAGAR |
| Address |
Department of Community Medicine and Family Medicine, academic block, AIIMS Bibinagar, HMR, yadadri bhuvangiri district, telangana.
Department of Community Medicine and Family Medicine, academic block, AIIMS Bibinagar, HMR, yadadri bhuvangiri district, telangana.
Nalgonda
TELANGANA
508126
India |
| Phone |
9880496567 |
| Fax |
|
| Email |
dr.rashmi.kundapur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr RASHMI KUNDAPUR |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
AIIMS BIBINAGAR |
| Address |
Department of Community Medicine and Family Medicine, academic block, AIIMS Bibinagar, HMR, yadadri bhuvangiri district, telangana.
Department of Community Medicine and Family Medicine, academic block, AIIMS Bibinagar, HMR, yadadri bhuvangiri district, telangana.
Nalgonda
TELANGANA
508126
India |
| Phone |
9880496567 |
| Fax |
|
| Email |
dr.rashmi.kundapur@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Venkatesh |
| Address |
AIIMS bibinagar , HMR, yadadri bhuvangiri district, Telangana 508126 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Venkatesh |
AIIMS BIBIBNAGAR , |
Department of Community Medicine and Family Medicine, academic block,
Nalgonda
TELANGANA |
08073177371
DR.VENKATESHPOBBATHI3@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Bibinagar Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PLANNED PHYSICAL ACTIVITY MODULE |
A 12-month physical activity health education intervention for hypertensive patients, incorporating a planned physical activity module with monthly follow-ups, alongside standard care. |
| Comparator Agent |
standard care of treatment |
standard care of treatment as they were following before |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
average change of blood pressure in adult
hypertensives on PPAM compared to control group. erage change of blood pressure in adult
hypertensive on PPPAM compared to control group. |
at a monthly interval for 12 months , the participiants are checked for blood pressure and physical activity profile |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| at a monthly interval for 12 months , the participants are checked for average blood pressure changes |
at monthly interval for 12 months
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
31/07/2025 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) - nil
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response (Others) - nil
- Who will be able to view these files?
Response (Others) - nil
- For what types of analyses will this data be available?
Response (Others) - nil
- By what mechanism will data be made available?
Response (Others) - nil
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response (Others) - nil
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
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 |