| CTRI Number |
CTRI/2024/03/064498 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exploring the Role of Aerobic Exercise in Alleviating Hypertension among Working Adults |
|
Scientific Title of Study
|
Effects of aerobic exercise in hypertension conditions on working adults
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankit |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
E003 Galgotias University E003 Galgotias University Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
9350995050 |
| Fax |
|
| Email |
tanwarankit012@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shahiduz Zafar |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
E003 Galgotias University E003 Galgotias University Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
9811701345 |
| Fax |
|
| Email |
shahiduz.zafar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ankit |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
E003 Galgotias University E003 Galgotias University Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
9350995050 |
| Fax |
|
| Email |
tanwarankit012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Reseach and Development cell Galgotias University |
|
|
Primary Sponsor
|
| Name |
Galgotias University Reseach and development Cell |
| Address |
Galgotias University campus Plot No. 2, Yamuna Expressway, Opposite, Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Ankit |
School Of Allied Health Sciences Galgotias University |
B512 Galgotias University Gautam Buddha Nagar UTTAR PRADESH |
9350995050
tanwarankit012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
aerobic exercises with Medication of Hypertensions |
5-10 Session for 30 Min |
| Intervention |
aerobic exercises with Special Diet Plans for managing hypertensions |
3-5 Seesion /Per Week |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Participants must be currently Working.(Age 30-45)
Participants must have a diagnosis of hypertension.
Participants must be willing to engage in regular aerobic exercise for the duration of the study.
Participants must have no contraindications to aerobic exercise.
Participants must be willing to comply with the study protocol, including attending all study visits and providing necessary data.
|
|
| ExclusionCriteria |
| Details |
Participants with a history of cardiovascular disease or other serious medical conditions.
Participants who are pregnant or planning to become pregnant during the study period.
Participants who are currently taking medications for hypertension or any other medications that may impact blood pressure levels.
Participants who have engaged in regular aerobic exercise within the past six months.
Participants who are unable to engage in physical activity due to physical disabilities or limitations.
Participants who are unwilling or unable to comply with the study protocol.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Blood pressure scale
|
8weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Diet intake chart
|
8 week |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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="3" Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Hypertension, or high blood pressure, is a common health concern affecting millions of people worldwide. It is a chronic medical condition that occurs when the blood pressure in the arteries is consistently elevated, leading to an increased risk of heart disease, stroke, and other related health problems. Hypertension can be caused by several factors, including a sedentary lifestyle, poor dietary habits, stress, and genetic predisposition [1]. Working Adults are among the populations at risk of developing hypertension due to their lifestyle choices, which may include a lack of physical activity, unhealthy dietary habits, and high levels of stress. According to the American Heart Association, hypertension is prevalent among young adults, with up to 10% of individuals aged 18-39 years having high blood pressure[2]. Physical exercise is a well-known intervention for managing hypertension and improving cardiovascular health. Aerobic exercise, in particular, has been shown to lower blood pressure and reduce the risk of hypertension in various populations, including individuals with hypertension. Aerobic exercise refers to activities that increase heart rate and respiration, such as walking, jogging, swimming, and cycling. Despite the known benefits of aerobic exercise on hypertension, little is known about its effects on college-going students. This study aims to investigate the effects of aerobic exercise on hypertension conditions in Working Adults. The findings of this study could provide valuable insights into the potential benefits of aerobic exercise in managing hypertension among young adults and inform interventions to improve the cardiovascular health of Working Adults [3]. Hypertension is a chronic medical condition that affects millions of people worldwide. According to the World Health Organization (WHO), hypertension is responsible for 9.4 million deaths globally each year. In the United States, hypertension affects approximately one in every three adults and is a leading risk factor for heart disease, stroke, and kidney failure [4]. Working Adults are a population at risk of developing hypertension due to their lifestyle choices. A sedentary lifestyle, unhealthy dietary habits, and high levels of stress are common among Working Adults and can contribute to the development of hypertension. According to the American Heart Association, young adults are at risk of developing hypertension, with up to 10% of individuals aged 18-39 years having high blood pressure [4]. |